Trial Outcomes & Findings for Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in MALT Lymphoma (NCT NCT00210353)
NCT ID: NCT00210353
Last Updated: 2019-06-06
Results Overview
Percentage of patients without events (failure of treatment or Death from any cause) after 5 years from trial registration
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
454 participants
Primary outcome timeframe
5 years
Results posted on
2019-06-06
Participant Flow
Subjects were enrolled from 10 January 2003 to 07 July 2010
Participant milestones
| Measure |
ARM B - Rituximab + Chlorambucil
rituximab 375 mg/m2 iv, d1, d8, d15, d22 chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
|
ARM C (Since April 2006) - Rituximab
Rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
|
ARM A - Chlorambucil
Chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
|
|---|---|---|---|
|
Overall Study
STARTED
|
152
|
151
|
151
|
|
Overall Study
COMPLETED
|
107
|
125
|
113
|
|
Overall Study
NOT COMPLETED
|
45
|
26
|
38
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in MALT Lymphoma
Baseline characteristics by cohort
| Measure |
ARM A - Chlorambucil
n=131 Participants
Chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
|
ARM B - Rituximab + Chlorambucil
n=132 Participants
Rituximab 375 mg/m2 iv, d1, d8, d15, d22 Chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
|
ARM C (Since April 2006) - Rituximab
n=138 Participants
Rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
|
Total
n=401 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
59.5 years
n=7 Participants
|
62.5 years
n=5 Participants
|
61 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
204 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
197 Participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
15 participants
n=5 Participants
|
28 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
54 participants
n=5 Participants
|
52 participants
n=7 Participants
|
58 participants
n=5 Participants
|
164 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
18 participants
n=5 Participants
|
23 participants
n=7 Participants
|
19 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
Region of Enrollment
France
|
39 participants
n=5 Participants
|
40 participants
n=7 Participants
|
41 participants
n=5 Participants
|
120 participants
n=4 Participants
|
|
Region of Enrollment
Switzerland
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
0 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Ann Arbor stage
Ann Arbor Stage > 2
|
53 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
|
Ann Arbor stage
Ann arbor stage ≤ 2
|
78 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
226 Participants
n=4 Participants
|
|
B-symptoms
Presence of B-symptoms
|
6 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
B-symptoms
Absence of B symptoms
|
125 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
359 Participants
n=4 Participants
|
|
International Prognostic Index (IPI) risk
Low
|
79 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
229 Participants
n=4 Participants
|
|
International Prognostic Index (IPI) risk
Low-intermediate
|
25 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
International Prognostic Index (IPI) risk
Intermediate-high
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
International Prognostic Index (IPI) risk
High
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
International Prognostic Index (IPI) risk
NA
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Evaluable patients
Percentage of patients without events (failure of treatment or Death from any cause) after 5 years from trial registration
Outcome measures
| Measure |
ARM A - Chlorambucil
n=131 Participants
Chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
|
ARM B - Rituximab + Chlorambucil
n=132 Participants
Rituximab 375 mg/m2 iv, d1, d8, d15, d22 chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
|
ARM C (Since April 2006) - Rituximab
n=138 Participants
Rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
|
|---|---|---|---|
|
Event-free-survival (EFS)
|
51 percentage of patients
Interval 42.0 to 60.0
|
68 percentage of patients
Interval 60.0 to 76.0
|
51 percentage of patients
Interval 42.0 to 60.0
|
SECONDARY outcome
Timeframe: End of treatment (after 24 weeks of therapy)Population: Evaluable patients
Response criteria were defined according to the NCI standardized response criteria for non-Hodgkin's lymphoma. Complete response. Disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms, if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. Regression of all lymph nodes and nodal masses to normal (≤ 1.5 cm in their greatest transverse diameter for nodes \> 1.5 cm before therapy and to ≤ 1 cm for nodes that were 1.1-1.5 cm. Regression by more than 75% in the sum of the products of the greatest diameters). Partial response. Decrease by at least 50% in SPD of the six largest measurable lesions. It is not necessary for all lesions to have regressed to qualify for partial response, but no lesion should have progressed and no new lesion should appear. For primary gastric sites, response was based on GELA histologic grading system.
Outcome measures
| Measure |
ARM A - Chlorambucil
n=131 Participants
Chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
|
ARM B - Rituximab + Chlorambucil
n=132 Participants
Rituximab 375 mg/m2 iv, d1, d8, d15, d22 chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
|
ARM C (Since April 2006) - Rituximab
n=138 Participants
Rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
|
|---|---|---|---|
|
Complete and Partial Remission Rate - Percentage of Patients With Complete and Partial Response at the End of Treatment
|
85.5 percentage of patients
Interval 78.3 to 91.0
|
94.7 percentage of patients
Interval 89.4 to 97.8
|
78.3 percentage of patients
Interval 70.4 to 84.8
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Evaluable patients
Response criteria were defined according to the NCI standardized response criteria for non-Hodgkin's lymphoma. Complete response (CR). Disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms, if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. Regression of all lymph nodes and nodal masses to normal (≤ 1.5 cm in their greatest transverse diameter for nodes \> 1.5 cm before therapy and to ≤ 1 cm for nodes that were 1.1-1.5 cm. Regression by more than 75% in the sum of the products of the greatest diameters).
Outcome measures
| Measure |
ARM A - Chlorambucil
n=131 Participants
Chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
|
ARM B - Rituximab + Chlorambucil
n=132 Participants
Rituximab 375 mg/m2 iv, d1, d8, d15, d22 chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
|
ARM C (Since April 2006) - Rituximab
n=138 Participants
Rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
|
|---|---|---|---|
|
Response Duration (Time to Relapse or Progression) - Percentage of Patients in Continuous Remission at Five Years From Trial Registration
|
70 percentage of patients
Interval 60.0 to 78.0
|
79 percentage of patients
Interval 71.0 to 85.0
|
66 percentage of patients
Interval 56.0 to 74.0
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Evaluable Patients
Percentage of patients without disease progression after 5 years from trial registration
Outcome measures
| Measure |
ARM A - Chlorambucil
n=131 Participants
Chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
|
ARM B - Rituximab + Chlorambucil
n=132 Participants
Rituximab 375 mg/m2 iv, d1, d8, d15, d22 chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
|
ARM C (Since April 2006) - Rituximab
n=138 Participants
Rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
|
|---|---|---|---|
|
Progression-free-survival (PFS)
|
59 percentage of patients
Interval 50.0 to 68.0
|
72 percentage of patients
Interval 63.0 to 79.0
|
57 percentage of patients
Interval 48.0 to 65.0
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Evaluable Patients
Percentage of patients alive after 5 years from trial registration
Outcome measures
| Measure |
ARM A - Chlorambucil
n=131 Participants
Chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
|
ARM B - Rituximab + Chlorambucil
n=132 Participants
Rituximab 375 mg/m2 iv, d1, d8, d15, d22 chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
|
ARM C (Since April 2006) - Rituximab
n=138 Participants
Rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
|
|---|---|---|---|
|
Overall Survival
|
89 percentage of patients
Interval 82.0 to 93.0
|
90 percentage of patients
Interval 83.0 to 94.0
|
92 percentage of patients
Interval 86.0 to 96.0
|
Adverse Events
ARM A
Serious events: 4 serious events
Other events: 42 other events
Deaths: 20 deaths
ARM B
Serious events: 20 serious events
Other events: 77 other events
Deaths: 25 deaths
ARM C (Since April 2006)
Serious events: 13 serious events
Other events: 59 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
ARM A
n=131 participants at risk
chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
chlorambucil (drug): chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment, two weeks rest, chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
|
ARM B
n=132 participants at risk
rituximab 375 mg/m2 iv, d1, d8, d15, d22 chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
rituximab+chlorambucil: rituximab 375 mg/m2 iv, d1, 8, 15, 22, chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment, ; two weeks rest; chlorambucil 6 mg/m2 os, daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
|
ARM C (Since April 2006)
n=138 participants at risk
rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
rituximab: rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.76%
1/131 • Number of events 1 • Seven years and eight months
|
0.00%
0/132 • Seven years and eight months
|
0.00%
0/138 • Seven years and eight months
|
|
Investigations
Transaminases increased
|
0.76%
1/131 • Number of events 1 • Seven years and eight months
|
0.76%
1/132 • Number of events 1 • Seven years and eight months
|
0.00%
0/138 • Seven years and eight months
|
|
Infections and infestations
Pneumonia
|
0.76%
1/131 • Number of events 1 • Seven years and eight months
|
0.76%
1/132 • Number of events 1 • Seven years and eight months
|
0.00%
0/138 • Seven years and eight months
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.76%
1/131 • Number of events 1 • Seven years and eight months
|
0.00%
0/132 • Seven years and eight months
|
0.00%
0/138 • Seven years and eight months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/131 • Seven years and eight months
|
0.76%
1/132 • Number of events 1 • Seven years and eight months
|
0.00%
0/138 • Seven years and eight months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/131 • Seven years and eight months
|
0.76%
1/132 • Number of events 1 • Seven years and eight months
|
0.00%
0/138 • Seven years and eight months
|
|
General disorders
Death NOS
|
0.00%
0/131 • Seven years and eight months
|
0.76%
1/132 • Number of events 1 • Seven years and eight months
|
0.00%
0/138 • Seven years and eight months
|
|
Injury, poisoning and procedural complications
Accident at home
|
0.00%
0/131 • Seven years and eight months
|
0.76%
1/132 • Number of events 1 • Seven years and eight months
|
0.00%
0/138 • Seven years and eight months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/131 • Seven years and eight months
|
0.76%
1/132 • Number of events 1 • Seven years and eight months
|
0.00%
0/138 • Seven years and eight months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal Cancer stage unspecified
|
0.00%
0/131 • Seven years and eight months
|
0.76%
1/132 • Number of events 1 • Seven years and eight months
|
0.00%
0/138 • Seven years and eight months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/131 • Seven years and eight months
|
0.76%
1/132 • Number of events 1 • Seven years and eight months
|
0.00%
0/138 • Seven years and eight months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/131 • Seven years and eight months
|
0.76%
1/132 • Number of events 1 • Seven years and eight months
|
0.00%
0/138 • Seven years and eight months
|
|
Eye disorders
Vision blurred
|
0.00%
0/131 • Seven years and eight months
|
0.76%
1/132 • Number of events 1 • Seven years and eight months
|
0.00%
0/138 • Seven years and eight months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukemia
|
0.00%
0/131 • Seven years and eight months
|
0.76%
1/132 • Number of events 1 • Seven years and eight months
|
0.00%
0/138 • Seven years and eight months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/131 • Seven years and eight months
|
2.3%
3/132 • Number of events 3 • Seven years and eight months
|
0.00%
0/138 • Seven years and eight months
|
|
General disorders
Injection site thrombosis
|
0.00%
0/131 • Seven years and eight months
|
0.76%
1/132 • Number of events 1 • Seven years and eight months
|
0.00%
0/138 • Seven years and eight months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/131 • Seven years and eight months
|
1.5%
2/132 • Number of events 2 • Seven years and eight months
|
1.4%
2/138 • Number of events 2 • Seven years and eight months
|
|
Infections and infestations
Urosepsis
|
0.00%
0/131 • Seven years and eight months
|
0.76%
1/132 • Number of events 1 • Seven years and eight months
|
0.00%
0/138 • Seven years and eight months
|
|
Surgical and medical procedures
Stent removal
|
0.00%
0/131 • Seven years and eight months
|
0.76%
1/132 • Number of events 1 • Seven years and eight months
|
0.00%
0/138 • Seven years and eight months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/131 • Seven years and eight months
|
0.76%
1/132 • Number of events 1 • Seven years and eight months
|
0.00%
0/138 • Seven years and eight months
|
|
General disorders
Pyrexia
|
0.00%
0/131 • Seven years and eight months
|
0.76%
1/132 • Number of events 1 • Seven years and eight months
|
1.4%
2/138 • Number of events 2 • Seven years and eight months
|
|
Reproductive system and breast disorders
metrorrhagia
|
0.00%
0/131 • Seven years and eight months
|
0.00%
0/132 • Seven years and eight months
|
0.72%
1/138 • Number of events 1 • Seven years and eight months
|
|
Gastrointestinal disorders
gastrointestinal obstruction
|
0.00%
0/131 • Seven years and eight months
|
0.00%
0/132 • Seven years and eight months
|
0.72%
1/138 • Number of events 1 • Seven years and eight months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/131 • Seven years and eight months
|
0.00%
0/132 • Seven years and eight months
|
0.72%
1/138 • Number of events 1 • Seven years and eight months
|
|
Immune system disorders
Allergic reactions
|
0.00%
0/131 • Seven years and eight months
|
0.00%
0/132 • Seven years and eight months
|
0.72%
1/138 • Number of events 1 • Seven years and eight months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/131 • Seven years and eight months
|
0.00%
0/132 • Seven years and eight months
|
0.72%
1/138 • Number of events 1 • Seven years and eight months
|
|
Infections and infestations
Sepsis NOS
|
0.00%
0/131 • Seven years and eight months
|
0.00%
0/132 • Seven years and eight months
|
0.72%
1/138 • Number of events 1 • Seven years and eight months
|
|
Infections and infestations
Infection NOS
|
0.00%
0/131 • Seven years and eight months
|
0.00%
0/132 • Seven years and eight months
|
1.4%
2/138 • Number of events 2 • Seven years and eight months
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/131 • Seven years and eight months
|
0.00%
0/132 • Seven years and eight months
|
0.72%
1/138 • Number of events 1 • Seven years and eight months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/131 • Seven years and eight months
|
0.00%
0/132 • Seven years and eight months
|
0.72%
1/138 • Number of events 1 • Seven years and eight months
|
|
General disorders
Disease prpgression NOS
|
0.76%
1/131 • Number of events 1 • Seven years and eight months
|
0.00%
0/132 • Seven years and eight months
|
0.00%
0/138 • Seven years and eight months
|
Other adverse events
| Measure |
ARM A
n=131 participants at risk
chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
chlorambucil (drug): chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment, two weeks rest, chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
|
ARM B
n=132 participants at risk
rituximab 375 mg/m2 iv, d1, d8, d15, d22 chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
rituximab+chlorambucil: rituximab 375 mg/m2 iv, d1, 8, 15, 22, chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment, ; two weeks rest; chlorambucil 6 mg/m2 os, daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
|
ARM C (Since April 2006)
n=138 participants at risk
rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
rituximab: rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
|
|---|---|---|---|
|
General disorders
Fatigue
|
12.2%
16/131 • Number of events 16 • Seven years and eight months
|
9.8%
13/132 • Number of events 13 • Seven years and eight months
|
11.6%
16/138 • Number of events 16 • Seven years and eight months
|
|
General disorders
Pyrexia
|
0.76%
1/131 • Number of events 1 • Seven years and eight months
|
4.5%
6/132 • Number of events 6 • Seven years and eight months
|
6.5%
9/138 • Number of events 9 • Seven years and eight months
|
|
Gastrointestinal disorders
Nausea
|
5.3%
7/131 • Number of events 7 • Seven years and eight months
|
13.6%
18/132 • Number of events 18 • Seven years and eight months
|
5.1%
7/138 • Number of events 7 • Seven years and eight months
|
|
Infections and infestations
Infection
|
13.0%
17/131 • Number of events 17 • Seven years and eight months
|
9.8%
13/132 • Number of events 13 • Seven years and eight months
|
10.1%
14/138 • Number of events 14 • Seven years and eight months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.9%
9/131 • Number of events 9 • Seven years and eight months
|
8.3%
11/132 • Number of events 11 • Seven years and eight months
|
5.1%
7/138 • Number of events 7 • Seven years and eight months
|
|
General disorders
Infusion related reactions
|
0.00%
0/131 • Seven years and eight months
|
15.9%
21/132 • Number of events 21 • Seven years and eight months
|
14.5%
20/138 • Number of events 20 • Seven years and eight months
|
Additional Information
Prof. Emanuele Zucca MD, Scientific and Medical Director
International Extranodal Lymphoma Study Group (IELSG)
Phone: +41 91 811 9040
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place