Trial Outcomes & Findings for Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma (NCT NCT01040871)
NCT ID: NCT01040871
Last Updated: 2014-01-13
Results Overview
Complete response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma. 1. Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. 2. PET scan was negative. 3. The spleen and/or liver, if enlarged before therapy on the basis of physical examination or CT scan, was not palpable on physical examination and was considered normal size by imaging studies; all splenic and hepatic nodules related to lymphomas disappeared. 4. If bone marrow was involved before treatment, the infiltrate cleared on repeated bone marrow biopsy. 5. No new sites of disease were detected.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
164 participants
Primary outcome timeframe
6 cycles
Results posted on
2014-01-13
Participant Flow
164 participants were randomized, three participants did not receive study treatment (2 in the VR-CAP and 1 in the R-CHOP arm) for a total of 161 treated.
Participant milestones
| Measure |
VR-CAP
VR-CAP arm received rituximab 375 mg/m2 IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, VELCADE 1.3 mg/m2 IV on Days 1, 4, 8, and 11, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.
|
R-CHOP
R-CHOP received rituximab 375 mg/m2IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, vincristine 1.4 mg/m2 (maximum total of 2 mg) IV on Day 1, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.Prednisone
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
80
|
|
Overall Study
COMPLETED
|
71
|
73
|
|
Overall Study
NOT COMPLETED
|
13
|
7
|
Reasons for withdrawal
| Measure |
VR-CAP
VR-CAP arm received rituximab 375 mg/m2 IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, VELCADE 1.3 mg/m2 IV on Days 1, 4, 8, and 11, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.
|
R-CHOP
R-CHOP received rituximab 375 mg/m2IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, vincristine 1.4 mg/m2 (maximum total of 2 mg) IV on Day 1, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.Prednisone
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Death
|
1
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
drug supply issue
|
1
|
0
|
|
Overall Study
Randomized and Not Treated
|
2
|
1
|
Baseline Characteristics
Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
VR-CAP
n=84 Participants
VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
|
R-CHOP
n=80 Participants
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 15.00 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 13.83 • n=7 Participants
|
57.2 years
STANDARD_DEVIATION 14.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
22 participants
n=5 Participants
|
14 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
4 participants
n=5 Participants
|
12 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
India
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
13 participants
n=5 Participants
|
8 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
France
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Ireland
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 cyclesPopulation: All randomized subjects with non-GCB DLBCL who received at least 1 dose of any study drug, had at least 1 measurable lesion at baseline, and had at least 1 post-baseline response assessment
Complete response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma. 1. Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. 2. PET scan was negative. 3. The spleen and/or liver, if enlarged before therapy on the basis of physical examination or CT scan, was not palpable on physical examination and was considered normal size by imaging studies; all splenic and hepatic nodules related to lymphomas disappeared. 4. If bone marrow was involved before treatment, the infiltrate cleared on repeated bone marrow biopsy. 5. No new sites of disease were detected.
Outcome measures
| Measure |
VR-CAP
n=76 Participants
VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
|
R-CHOP
n=74 Participants
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
|
|---|---|---|
|
Complete Response (CR) Rate
|
64.5 percentage of participants
Interval 55.4 to 73.5
|
63.5 percentage of participants
Interval 54.3 to 72.7
|
SECONDARY outcome
Timeframe: 6 cyclesPopulation: All randomized subjects with non-GCB DLBCL who received at least 1 dose of any study drug, had at least 1 measurable lesion at baseline, and had at least 1 post-baseline response assessment
Overall response = Complete Response (CR) + Partial Response (PR) Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, and end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma. Complete Response: see primary endpoint Partial Response: At least a 50% decrease in the sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses.
Outcome measures
| Measure |
VR-CAP
n=76 Participants
VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
|
R-CHOP
n=74 Participants
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
|
|---|---|---|
|
Overall Response Rate
|
93.4 percentage of participants
Interval 88.7 to 98.1
|
98.6 percentage of participants
Interval 96.4 to 100.0
|
SECONDARY outcome
Timeframe: Median follow up approx. 12 monthsProportion of subjects who achieved a CR or PR with duration of at least 6 months. Duration of response (CR or PR) was calculated from the date of initial documentation of a response to the date of first documented evidence of disease progression or death due to disease progression. Response was evaluated by an Independent Radiology Review Committee using available computed tomography (CT) and positron emission tomography (PET) scans collected at Baseline, end of cycle 3, end of cycle 6 (or end of treatment) based on the Revised Response Criteria for Malignant Lymphoma.
Outcome measures
| Measure |
VR-CAP
n=76 Participants
VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
|
R-CHOP
n=74 Participants
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
|
|---|---|---|
|
Rate of Durable Response
|
53.9 percentage of participants
Interval 44.5 to 63.4
|
67.6 percentage of participants
Interval 58.6 to 76.5
|
SECONDARY outcome
Timeframe: Median follow up approx 12 monthsProportion of subjects who achieved a CR with duration of at least 6 months
Outcome measures
| Measure |
VR-CAP
n=76 Participants
VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
|
R-CHOP
n=74 Participants
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
|
|---|---|---|
|
Rate of Durable Complete Response
|
44.7 percentage of participants
Interval 35.3 to 54.1
|
47.3 percentage of participants
Interval 37.7 to 56.9
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Intent to Treat Population
Kaplan-meier estimate of subsequent anti-lymphoma therapy at 1-year. Time to subsequent anti-lymphoma therapy was measured from the date of randomization to the start date of new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti-lymphoma treatment was censored at the date of death or the last date known to be alive.
Outcome measures
| Measure |
VR-CAP
n=84 Participants
VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
|
R-CHOP
n=80 Participants
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
|
|---|---|---|
|
Subsequent Anti-lymphoma Therapy Rate at 1-year
|
71.1 percentage of participants
Interval 57.9 to 80.8
|
80.2 percentage of participants
Interval 68.8 to 87.9
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Intent to Treat Population
Kaplan-meier estimate of progression-free survival at 1-year. Progression-free survival was defined as the interval between the date of randomization and the date of first documented evidence of disease progression or death.
Outcome measures
| Measure |
VR-CAP
n=84 Participants
VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
|
R-CHOP
n=80 Participants
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
|
|---|---|---|
|
Progression-free Survival (PFS)Rate at 1-year
|
78.9 percentage of partipants
Interval 67.2 to 86.8
|
83.9 percentage of partipants
Interval 72.7 to 90.8
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Intent to Treat Population
Kaplan-meier estimate of overall survival at 1-year measured from date of randomization.
Outcome measures
| Measure |
VR-CAP
n=84 Participants
VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
|
R-CHOP
n=80 Participants
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
|
|---|---|---|
|
Overall Survival Rate at 1-year
|
94.1 percentage of partipants
Interval 84.6 to 97.8
|
84.2 percentage of partipants
Interval 73.2 to 91.0
|
SECONDARY outcome
Timeframe: 18-24 monthsOutcome measures
Outcome data not reported
Adverse Events
VR-CAP
Serious events: 31 serious events
Other events: 73 other events
Deaths: 0 deaths
R-CHOP
Serious events: 27 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VR-CAP
n=82 participants at risk
VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
|
R-CHOP
n=79 participants at risk
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.5%
7/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
8.9%
7/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.9%
4/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
6.3%
5/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Blood and lymphatic system disorders
Splenomegaly
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Infections and infestations
Pneumonia
|
4.9%
4/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
3.8%
3/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Infections and infestations
Device related infection
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Infections and infestations
Gastroenteritis
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Infections and infestations
Lung infection
|
2.4%
2/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Infections and infestations
Septic shock
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Infections and infestations
Abscess neck
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Infections and infestations
Herpes zoster
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Infections and infestations
Oral candidiasis
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Infections and infestations
Respiratory tract infection
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Infections and infestations
Sepsis
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Infections and infestations
Skin infection
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
2/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Gastrointestinal disorders
Dyphagia
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
General disorders
Pyrexia
|
6.1%
5/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
General disorders
Asthenia
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
General disorders
Chest pain
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
General disorders
General physical health deterioration
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
General disorders
Malaise
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
General disorders
Performance status decreased
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Cardiac disorders
Cardiac arrest
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Cardiac disorders
Cardiac failure acute
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Cardiac disorders
Extrasystoles
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Cardiac disorders
Pericarditis
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Nervous system disorders
Cerebrovascular accident
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Nervous system disorders
Dizziness
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Nervous system disorders
Paraesthesia
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Nervous system disorders
Syncope
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
2/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.4%
2/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Vascular disorders
Hypotension
|
2.4%
2/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Vascular disorders
Hypertension
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Vascular disorders
Orthostatic hypotension
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Vascular disorders
Venous thrombosis
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Ear and labyrinth disorders
Vertigo
|
2.4%
2/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Metabolism and nutrition disorders
Hyperphosphatasaemia
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Eye disorders
Retinal detachment
|
1.2%
1/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Investigations
International normalised ratio increased
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Skin and subcutaneous tissue disorders
Skin discoloration
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
Other adverse events
| Measure |
VR-CAP
n=82 participants at risk
VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
|
R-CHOP
n=79 participants at risk
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
29.3%
24/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
31.6%
25/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Gastrointestinal disorders
Dyspepsia
|
13.4%
11/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
8.9%
7/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Gastrointestinal disorders
Stomatitis
|
11.0%
9/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
8.9%
7/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.0%
9/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
5.1%
4/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
28.0%
23/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
19.0%
15/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Nervous system disorders
Headache
|
11.0%
9/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
10.1%
8/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Nervous system disorders
Hypoaesthesia
|
9.8%
8/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
5.1%
4/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Nervous system disorders
Neuralgia
|
11.0%
9/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
0.00%
0/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Nervous system disorders
Dysgeusia
|
6.1%
5/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
General disorders
Fatigue
|
25.6%
21/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
13.9%
11/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
General disorders
Oedema peripheral
|
17.1%
14/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
6.3%
5/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
General disorders
Chills
|
2.4%
2/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
6.3%
5/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.4%
11/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
7.6%
6/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.5%
7/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
2.5%
2/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.7%
3/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
7.6%
6/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.1%
5/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
3.8%
3/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Infections and infestations
Nasopharyngitis
|
7.3%
6/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
3.8%
3/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.1%
14/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
13.9%
11/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.3%
6/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
6.3%
5/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.2%
10/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
5.1%
4/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
7.3%
6/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Blood and lymphatic system disorders
Anaemia
|
23.2%
19/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
21.5%
17/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.9%
13/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
6.3%
5/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.3%
6/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
2.5%
2/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
5.1%
4/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Psychiatric disorders
Insomnia
|
12.2%
10/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
7.6%
6/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
9.8%
8/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
11.4%
9/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Eye disorders
Conjunctivitis
|
6.1%
5/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
1.3%
1/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
|
Investigations
Weight decreased
|
7.3%
6/82
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
5.1%
4/79
Number at risk is based on the safety population defined as patients who were randomized and received at least one dose of study drug. A total of 164 participants were randomized and 3 participants did not receive study treatment (2 in the VR-CAP arm, 1 in the R-CHOP arm) for a total of 161 treated (82 in the VR-CAP arm, 79 in the R-CHOP arm).
|
Additional Information
Dr. Helgi van de Velde
Johnson & Johnson Pharmaceutical Research & Development
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place