Trial Outcomes & Findings for Study of VELCADE and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (NCT NCT00312845)
NCT ID: NCT00312845
Last Updated: 2012-06-25
Results Overview
Progression free survival is defined as time from randomization to progressive disease or death due to any cause, whichever occurs first.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
676 participants
Primary outcome timeframe
Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.
Results posted on
2012-06-25
Participant Flow
Participant milestones
| Measure |
Bortezomib + Rituximab
1.6 mg/m\^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m\^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m\^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
|
Rituximab
375 mg/m\^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m\^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
|
|---|---|---|
|
Overall Study
STARTED
|
336
|
340
|
|
Overall Study
COMPLETED
|
237
|
245
|
|
Overall Study
NOT COMPLETED
|
99
|
95
|
Reasons for withdrawal
| Measure |
Bortezomib + Rituximab
1.6 mg/m\^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m\^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m\^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
|
Rituximab
375 mg/m\^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m\^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
|
|---|---|---|
|
Overall Study
Adverse Event
|
19
|
5
|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
14
|
6
|
|
Overall Study
Disease Progression
|
56
|
77
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Other
|
6
|
5
|
Baseline Characteristics
Study of VELCADE and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Bortezomib + Rituximab
n=336 Participants
1.6 mg/m\^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m\^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m\^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
|
Rituximab
n=340 Participants
375 mg/m\^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m\^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
|
Total
n=676 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
243 Participants
n=5 Participants
|
242 Participants
n=7 Participants
|
485 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
93 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Age Continuous
|
56.8 years
STANDARD_DEVIATION 11.12 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 12 • n=7 Participants
|
57 years
STANDARD_DEVIATION 11.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
164 Participants
n=5 Participants
|
203 Participants
n=7 Participants
|
367 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
172 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
309 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
52 participants
n=5 Participants
|
55 participants
n=7 Participants
|
107 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Region of Enrollment
India
|
17 participants
n=5 Participants
|
24 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Region of Enrollment
France
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
China
|
46 participants
n=5 Participants
|
40 participants
n=7 Participants
|
86 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
18 participants
n=5 Participants
|
21 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
18 participants
n=5 Participants
|
19 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
24 participants
n=5 Participants
|
21 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.Population: Intention to treat (ITT) population is defined as all patients randomized to the trial.
Progression free survival is defined as time from randomization to progressive disease or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Bortezomib + Rituximab
n=336 Participants
1.6 mg/m\^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m\^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m\^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
|
Rituximab
n=340 Participants
375 mg/m\^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m\^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
|
|---|---|---|
|
Progression Free Survival
|
389 days
Interval 351.0 to 456.0
|
334 days
Interval 278.0 to 365.0
|
SECONDARY outcome
Timeframe: Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.Population: The response-evaluable population was defined as all subjects in the ITT population who received at least 1 dose of VELCADE or rituximab, had at least 1 measurable tumor mass (\>1.5 cm in the longest dimension and \>1.0 cm in the short axis) at baseline, and had at least 1 post-baseline disease assessment by independent radiology reviewers/IRC.
Overall response rate is defined as Complete Response (CR) + Complete Response Unconfirmed (CRu) + Partial Response (PR) using International Working Group Criteria (IWGC) and Independent Radiographic Review results and clinical results. The IWGC CR requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms, and normalization of lactic dehydrogenase and bone marrow involvement. CRu requires more than 75% reduction in sum of product of nodes (SPD). PR requires moer than 50% reduction in SPD.
Outcome measures
| Measure |
Bortezomib + Rituximab
n=315 Participants
1.6 mg/m\^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m\^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m\^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
|
Rituximab
n=324 Participants
375 mg/m\^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m\^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
|
|---|---|---|
|
Overall Response Rate
|
199 participants
|
160 participants
|
Adverse Events
Bortezomib + Rituximab
Serious events: 59 serious events
Other events: 288 other events
Deaths: 0 deaths
Rituximab
Serious events: 37 serious events
Other events: 232 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bortezomib + Rituximab
n=334 participants at risk
1.6 mg/m\^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m\^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m\^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
|
Rituximab
n=339 participants at risk
375 mg/m\^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m\^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
2.1%
7/334 • the end of study
|
0.88%
3/339 • the end of study
|
|
Infections and infestations
Herpes zoster
|
1.2%
4/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Infections and infestations
Sepsis
|
0.90%
3/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/334 • the end of study
|
0.59%
2/339 • the end of study
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
5/334 • the end of study
|
0.59%
2/339 • the end of study
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
4/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Gastrointestinal disorders
Abdominal pain
|
0.60%
2/334 • the end of study
|
0.59%
2/339 • the end of study
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.5%
5/334 • the end of study
|
0.88%
3/339 • the end of study
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.60%
2/334 • the end of study
|
0.59%
2/339 • the end of study
|
|
General disorders
Pyrexia
|
1.8%
6/334 • the end of study
|
0.59%
2/339 • the end of study
|
|
General disorders
Asthenia
|
0.30%
1/334 • the end of study
|
0.59%
2/339 • the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.60%
2/334 • the end of study
|
0.59%
2/339 • the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.60%
2/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Nervous system disorders
Cerebrovascular accident
|
0.60%
2/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Immune system disorders
Hypersensitivity
|
1.2%
4/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Immune system disorders
Anaphylactic reaction
|
0.60%
2/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Vascular disorders
Hypotension
|
1.2%
4/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Renal and urinary disorders
Renal failure
|
0.60%
2/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Metabolism and nutrition disorders
Dehydration
|
0.60%
2/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Cardiac disorders
Left entricular dysfunction
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Cardiac disorders
Palpitations
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
General disorders
Chest pain
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
General disorders
Oedema peripheral
|
0.30%
1/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
General disorders
Pain
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Infections and infestations
Empyema
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Infections and infestations
Laryngitis
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Infections and infestations
Lower respiratory tract infection
|
0.30%
1/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Infections and infestations
Meningitis
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Infections and infestations
Necrotixing fasciitis
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Injury, poisoning and procedural complications
Collapse of lung
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Nervous system disorders
Convulsion
|
0.30%
1/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Nervous system disorders
Dementia
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Nervous system disorders
Somnolence
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.30%
1/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Blood and lymphatic system disorders
Anaemia
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Cardiac disorders
Acute myocardial infarction
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Cardiac disorders
Angina unstable
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Cardiac disorders
Cardiac failure acute
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Cardiac disorders
Cardiogenic shock
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Cardiac disorders
Coronary artery disease
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Cardiac disorders
Cyanosis
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Cardiac disorders
Tachycardia
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Gastrointestinal disorders
Constipation
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Gastrointestinal disorders
Dysphagia
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Gastrointestinal disorders
Nausea
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Gastrointestinal disorders
Periodontitis
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Gastrointestinal disorders
Toothache
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
General disorders
Chest discomfort
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Infections and infestations
Aspergillosis
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Infections and infestations
Hepatitis B
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Infections and infestations
Hepatitis viral
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Infections and infestations
Herpes virus infection
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Infections and infestations
Pyelonephritis
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Infections and infestations
Respiratory tract infection
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Infections and infestations
Septic shock
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Infections and infestations
Upper respiratory tract infection
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Injury, poisoning and procedural complications
Concussion
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Nervous system disorders
Loss of consciousness
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Nervous system disorders
Myelopathy
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Nervous system disorders
Syncope
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Nervous system disorders
Toxic encephalopathy
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Renal and urinary disorders
Renal failure acute
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Renal and urinary disorders
Renal impairment
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Pleural haemorrhage
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Vascular disorders
Orthostatic hypotension
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
|
Vascular disorders
Thrombosis
|
0.30%
1/334 • the end of study
|
0.00%
0/339 • the end of study
|
Other adverse events
| Measure |
Bortezomib + Rituximab
n=334 participants at risk
1.6 mg/m\^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m\^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m\^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
|
Rituximab
n=339 participants at risk
375 mg/m\^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m\^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.6%
32/334 • the end of study
|
3.8%
13/339 • the end of study
|
|
General disorders
Chills
|
8.4%
28/334 • the end of study
|
5.0%
17/339 • the end of study
|
|
General disorders
Fatigue
|
22.5%
75/334 • the end of study
|
8.0%
27/339 • the end of study
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
37/334 • the end of study
|
7.4%
25/339 • the end of study
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.8%
46/334 • the end of study
|
4.4%
15/339 • the end of study
|
|
Nervous system disorders
Headache
|
12.6%
42/334 • the end of study
|
7.1%
24/339 • the end of study
|
|
Nervous system disorders
Paraesthesia
|
11.7%
39/334 • the end of study
|
2.9%
10/339 • the end of study
|
|
Psychiatric disorders
Insomnia
|
9.0%
30/334 • the end of study
|
5.3%
18/339 • the end of study
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.3%
51/334 • the end of study
|
9.1%
31/339 • the end of study
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.5%
25/334 • the end of study
|
4.4%
15/339 • the end of study
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.2%
24/334 • the end of study
|
2.9%
10/339 • the end of study
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.0%
20/334 • the end of study
|
2.1%
7/339 • the end of study
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
4.8%
16/334 • the end of study
|
3.2%
11/339 • the end of study
|
|
Infections and infestations
Nasopharyngitis
|
6.6%
22/334 • the end of study
|
2.4%
8/339 • the end of study
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.8%
16/334 • the end of study
|
2.4%
8/339 • the end of study
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.4%
18/334 • the end of study
|
1.5%
5/339 • the end of study
|
|
Nervous system disorders
Dizziness
|
6.0%
20/334 • the end of study
|
2.7%
9/339 • the end of study
|
|
Nervous system disorders
Neuralgia
|
6.9%
23/334 • the end of study
|
0.29%
1/339 • the end of study
|
|
Vascular disorders
Hypertension
|
6.3%
21/334 • the end of study
|
2.7%
9/339 • the end of study
|
Additional Information
Yusri A. Elsayed, M.D., M.H.Sc., Ph.D.
Johnson & Johnson Pharmaceutical Research & Development
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place