Trial Outcomes & Findings for CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a) (NCT NCT01010061)
NCT ID: NCT01010061
Last Updated: 2018-09-14
Results Overview
PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator. Progressive disease (PD) required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (\>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels \>20 g/L or \<10 g/dL or a decrease of platelet counts \>50% or \<100 x 10\^9/L or by a decrease of neutrophil counts \>50% or \<1.0 x 10\^9/L).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
787 participants
Primary outcome timeframe
Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)
Results posted on
2018-09-14
Participant Flow
787 patients were enrolled in the study. Following a 6 patient safety run-in prior to randomization, 781 patients were randomized.
589 patients were randomized to 1 of 3 treatment groups in 2:2:1 ratio: GClb (n=238), RClb (n=233) or Clb (n=118) in Stage 1 and an additional 192 randomized to GClb or RClb in Stage 2 \[NCT02053610\]. Stage 1 was divided for analysis into: Stage 1a (GClb vs Clb) n=356 reported here and Stage 1b (RClb vs Clb) \[NCT01998880\] reported separately.
Participant milestones
| Measure |
Obinutuzumab + Chlorambucil (GClb)
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
|
Chlorambucil (Clb)
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
|
|---|---|---|
|
Overall Study
STARTED
|
238
|
118
|
|
Overall Study
Received Study Drug
|
236
|
116
|
|
Overall Study
COMPLETED
|
190
|
78
|
|
Overall Study
NOT COMPLETED
|
48
|
40
|
Reasons for withdrawal
| Measure |
Obinutuzumab + Chlorambucil (GClb)
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
|
Chlorambucil (Clb)
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
|
|---|---|---|
|
Overall Study
Adverse Events or Intercurrent Illness
|
33
|
16
|
|
Overall Study
Disease Progression
|
2
|
8
|
|
Overall Study
Withdrew Consent
|
5
|
1
|
|
Overall Study
Death
|
3
|
6
|
|
Overall Study
Administrative/Other
|
0
|
1
|
|
Overall Study
Refused Treatment/Did Not Cooperate
|
2
|
0
|
|
Overall Study
Insufficient Therapeutic Response
|
1
|
5
|
|
Overall Study
Violation of Selection Criteria
|
0
|
1
|
|
Overall Study
Did Not Receive Treatment
|
2
|
2
|
Baseline Characteristics
CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)
Baseline characteristics by cohort
| Measure |
Obinutuzumab + Chlorambucil (GClb)
n=238 Participants
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
|
Chlorambucil (Clb)
n=118 Participants
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
|
Total
n=356 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65 years
|
42 participants
n=5 Participants
|
26 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
196 participants
n=5 Participants
|
92 participants
n=7 Participants
|
288 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
140 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)Population: Intent-to-treat population included all randomized participants. Patients without PFS events were censored.
PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator. Progressive disease (PD) required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (\>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels \>20 g/L or \<10 g/dL or a decrease of platelet counts \>50% or \<100 x 10\^9/L or by a decrease of neutrophil counts \>50% or \<1.0 x 10\^9/L).
Outcome measures
| Measure |
Obinutuzumab + Chlorambucil (GClb)
n=238 Participants
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
|
Chlorambucil (Clb)
n=118 Participants
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
31.1 Months
Interval 26.5 to 35.6
|
11.1 Months
Interval 10.7 to 11.3
|
PRIMARY outcome
Timeframe: Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)Population: Intent-to-treat population included all randomized participants.
Percentage of Participants with Progression Free Survival Events: disease progression, relapse, or death.
Outcome measures
| Measure |
Obinutuzumab + Chlorambucil (GClb)
n=238 Participants
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
|
Chlorambucil (Clb)
n=118 Participants
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
|
|---|---|---|
|
Percentage of Participants With Progression Free Survival Events
|
72.7 Percentage of participants
|
90.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Randomization to clinical cutoff date of 9 May 2013 (median observation 22.8 months)Population: Intent-to-treat population included all randomized participants. Patients without PFS events were censored.
PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by Independent Review Committee. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (\>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels \>20 g/L or \<10 g/dL or a decrease of platelet counts \>50% or \<100 x 10\^9/L or by a decrease of neutrophil counts \>50% or \<1.0 x 10\^9/L).
Outcome measures
| Measure |
Obinutuzumab + Chlorambucil (GClb)
n=238 Participants
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
|
Chlorambucil (Clb)
n=118 Participants
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
|
|---|---|---|
|
Progression Free Survival Based on Independent Review Committee (IRC) Data
|
27.2 Months
Interval 23.5 to 33.0
|
11.2 Months
Interval 11.0 to 12.1
|
SECONDARY outcome
Timeframe: Randomization to clinical cutoff date of 9 May 2013 (median observation 22.8 months)Population: Intent-to-treat population included all randomized participants. Participants without PFS events were censored.
Percentage of Participants with Progression Free Survival Events: progression, relapse, or death from any cause as assessed by an Independent Review Committee.
Outcome measures
| Measure |
Obinutuzumab + Chlorambucil (GClb)
n=238 Participants
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
|
Chlorambucil (Clb)
n=118 Participants
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
|
|---|---|---|
|
Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data
|
37.4 Percentage of participants
|
76.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)Population: Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.
EOTR was the first response assessment 56 days from the last dose according to the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) guidelines. CR required: Peripheral blood lymphocytes below 4 x 10\^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils \>1.5 x 10\^9/L, Platelets \>100 x 10\^9/L, Hemoglobin \>11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils \>1.5 x 10\^9/ or ≥50% increase, Platelets \>100 x 10\^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.
Outcome measures
| Measure |
Obinutuzumab + Chlorambucil (GClb)
n=238 Participants
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
|
Chlorambucil (Clb)
n=118 Participants
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
|
|---|---|---|
|
Percentage of Participants With End of Treatment Response (EOTR)
Complete Response (CR)
|
17.2 Percentage of participants
Interval 12.7 to 22.6
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
|
Percentage of Participants With End of Treatment Response (EOTR)
Complete Response incomplete (CRi)
|
4.2 Percentage of participants
Interval 2.0 to 7.6
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
|
Percentage of Participants With End of Treatment Response (EOTR)
Partial Response (PR)
|
48.3 Percentage of participants
Interval 41.8 to 54.9
|
28.8 Percentage of participants
Interval 20.8 to 37.9
|
|
Percentage of Participants With End of Treatment Response (EOTR)
Nodular Partial Response (nPR)
|
7.6 Percentage of participants
Interval 4.5 to 11.7
|
2.5 Percentage of participants
Interval 0.5 to 7.3
|
|
Percentage of Participants With End of Treatment Response (EOTR)
Stable Disease
|
5 Percentage of participants
Interval 2.6 to 8.6
|
22.9 Percentage of participants
Interval 15.7 to 31.5
|
|
Percentage of Participants With End of Treatment Response (EOTR)
Progressive Disease
|
4.2 Percentage of participants
Interval 2.0 to 7.6
|
28.8 Percentage of participants
Interval 20.8 to 37.9
|
|
Percentage of Participants With End of Treatment Response (EOTR)
No Response Assessment
|
13.4 Percentage of participants
95% CI not estimated.
|
16.9 Percentage of participants
95% CI not estimated.
|
SECONDARY outcome
Timeframe: Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)Population: Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.
Best overall response according to IWCLL guidelines was defined as the percentage of patients with CR, CRi,PR or nPR. CR required all of the following: Peripheral blood lymphocytes below 4 x 10\^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils \>1.5 x 10\^9/L, Platelets \>100 x 10\^9/L, Hemoglobin \>11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils \>1.5 x 10\^9/ or ≥50% increase, Platelets \>100 x 10\^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.
Outcome measures
| Measure |
Obinutuzumab + Chlorambucil (GClb)
n=238 Participants
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
|
Chlorambucil (Clb)
n=118 Participants
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
|
|---|---|---|
|
Percentage of Participants With Best Overall Response
Complete Response (CR)
|
26.5 Percentage of participants
Interval 21.0 to 32.6
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
|
Percentage of Participants With Best Overall Response
Complete Response incomplete (CRi)
|
2.5 Percentage of participants
Interval 0.9 to 5.4
|
1.7 Percentage of participants
Interval 0.2 to 6.0
|
|
Percentage of Participants With Best Overall Response
Partial Response (PR)
|
47.1 Percentage of participants
Interval 40.6 to 53.6
|
31.4 Percentage of participants
Interval 23.1 to 40.5
|
|
Percentage of Participants With Best Overall Response
Nodular Partial Response (nPR)
|
2.1 Percentage of participants
Interval 0.7 to 4.8
|
0 Percentage of participants
Interval 0.0 to 3.1
|
|
Percentage of Participants With Best Overall Response
Stable Disease
|
4.2 Percentage of participants
Interval 2.0 to 7.6
|
21.2 Percentage of participants
Interval 14.2 to 29.7
|
|
Percentage of Participants With Best Overall Response
Progressive Disease
|
4.2 Percentage of participants
Interval 2.0 to 7.6
|
28.8 Percentage of participants
Interval 20.8 to 37.9
|
|
Percentage of Participants With Best Overall Response
No Response Assessment
|
13.4 Percentage of participants
95% CI was not estimated.
|
16.9 Percentage of participants
95% CI was not estimated.
|
SECONDARY outcome
Timeframe: Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)Population: Intent-to-treat population included all randomized participants. Patients without EFS events were censored.
Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy. Progressive disease as per IWCLL criteria required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (\>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels \>20 g/L or \<10 g/dL or a decrease of platelet counts \>50% or \<100 x 10\^9/L or by a decrease of neutrophil counts \>50% or \<1.0 x 10\^9/L).
Outcome measures
| Measure |
Obinutuzumab + Chlorambucil (GClb)
n=238 Participants
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
|
Chlorambucil (Clb)
n=118 Participants
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
|
|---|---|---|
|
Event Free Survival
|
28.7 Months
Interval 23.9 to 32.9
|
10.8 Months
Interval 8.0 to 11.1
|
SECONDARY outcome
Timeframe: Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)Population: Intent-to-treat population included all randomized participants. Patients without OS events were censored.
Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause.
Outcome measures
| Measure |
Obinutuzumab + Chlorambucil (GClb)
n=238 Participants
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
|
Chlorambucil (Clb)
n=118 Participants
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
|
|---|---|---|
|
Overall Survival
|
NA Months
Interval 74.2 to
The median survival time and upper limit of 95% CI could not be estimated due to a low number of deaths.
|
66.7 Months
Interval 50.9 to
The upper limit of 95% CI could not be estimated due to a low number of deaths.
|
SECONDARY outcome
Timeframe: Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)Population: Participants from the Intent-to-treat population (all randomized participants) with CR or PR. Participants without response were censored.
Duration of Response was defined as the date the response \[either Complete Response (CR) or Partial Response (PR)\] was first recorded until the date of Disease Progression or death due to any cause. Response was assessed according IWCLL guidelines.
Outcome measures
| Measure |
Obinutuzumab + Chlorambucil (GClb)
n=191 Participants
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
|
Chlorambucil (Clb)
n=41 Participants
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
|
|---|---|---|
|
Duration of Response
|
24.8 Months
Interval 22.1 to 33.5
|
5.1 Months
Interval 3.3 to 6.7
|
SECONDARY outcome
Timeframe: Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)Population: Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.
Molecular remission was defined as a minimal residual disease (MRD)-negative result at the end of treatment (assessment that occurred between 56 days and 6 months of last treatment). Molecular remission was assessed for all patients using a blood sample. Additionally, a bone marrow sample was obtained from patients whom the investigator assumed to have a complete response, consistent with the IWCLL guidelines. A combined analysis of blood and bone marrow results was conducted. A patient was considered MRD negative if result was less than 1 chronic lymphocytic leukemia (CLL) cell in 10000 leukocytes (MRD value \< 0.0001) based on the method of allele specific polymerase chain reaction (ASO-PCR).
Outcome measures
| Measure |
Obinutuzumab + Chlorambucil (GClb)
n=166 Participants
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
|
Chlorambucil (Clb)
n=90 Participants
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
|
|---|---|---|
|
Percentage of Participants With Molecular Remission at the End of Treatment
|
25 Percentage of participants
Interval 18.9 to 32.6
|
0 Percentage of participants
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)Population: Intent-to-treat population included all randomized participants. Participants without events (re-treatment or new anti-leukemic therapy) were censored.
Time to re-treatment/new anti-leukemic therapy was defined as time between the date of randomization and the date of first intake of re-treatment or new anti-leukemic therapy.
Outcome measures
| Measure |
Obinutuzumab + Chlorambucil (GClb)
n=238 Participants
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
|
Chlorambucil (Clb)
n=118 Participants
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
|
|---|---|---|
|
Time to Re-Treatment/New-antileukemic Therapy
|
55.7 Months
Interval 47.4 to
The upper level of the 95% CI was not reached.
|
15.1 Months
Interval 11.7 to 18.0
|
SECONDARY outcome
Timeframe: Pre- and post-dose sampling on day 1 of cycles 1-6 (Up to 26.8 months)Population: PK population includes all participants with PK data available at the given time-point.
Blood samples were collected from all patients allocated to the GClb treatment arm pre- and post-dose Day 1 of Cycles 1 to 6 and were sent to a laboratory. The concentration of obinutzumab in serum was determined using a validated enzyme-linked immunosorbent assay (ELISA) and was reported in micrograms/milliliter (μg/mL).
Outcome measures
| Measure |
Obinutuzumab + Chlorambucil (GClb)
n=220 Participants
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
|
Chlorambucil (Clb)
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
|
|---|---|---|
|
Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb)
Post-dose Cycle 1 (n=201)
|
247 μg/mL
Geometric Coefficient of Variation 41.6
|
—
|
|
Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb)
Pre-dose Cycle 2 (n=198)
|
227 μg/mL
Geometric Coefficient of Variation 57.9
|
—
|
|
Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb)
Post-dose Cycle 2 (n=197)
|
587 μg/mL
Geometric Coefficient of Variation 36.5
|
—
|
|
Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb)
Pre-dose Cycle 3 (n=193)
|
165 μg/mL
Geometric Coefficient of Variation 68.7
|
—
|
|
Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb)
Post-dose Cycle 3 (n=192)
|
527 μg/mL
Geometric Coefficient of Variation 39.7
|
—
|
|
Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb)
Pre-dose Cycle 4 (n=191)
|
156 μg/mL
Geometric Coefficient of Variation 74.3
|
—
|
|
Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb)
Post-dose Cycle 4 (n=189)
|
535 μg/mL
Geometric Coefficient of Variation 41.0
|
—
|
|
Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb)
Pre-dose Cycle 5 (n=185)
|
163 μg/mL
Geometric Coefficient of Variation 72.4
|
—
|
|
Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb)
Post-dose Cycle 5 (n=181)
|
534 μg/mL
Geometric Coefficient of Variation 39.1
|
—
|
|
Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb)
Pre-dose Cycle 6 (n=185)
|
181 μg/mL
Geometric Coefficient of Variation 69.0
|
—
|
|
Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb)
Post-dose Cycle 6 (n=183)
|
525 μg/mL
Geometric Coefficient of Variation 39.6
|
—
|
SECONDARY outcome
Timeframe: Baseline and Cycle 4 Day 1 (Cy4D1)Population: ITT population. Here, n signifies the number of participants who were evaluated for specified categories.
The EORTC Quality of Life Questionnaire QLQ-C30 was used to assess patient-reported outcomes (PRO) and symptom burden. The QLQ-C30 contains 30 items including the functional scales of physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items) and symptom scales including fatigue (3 items), nausea and vomiting (2 items), and pain (4 items) and six single item scales on dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact. Final scores are transformed such that they range from 0 - 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.
Outcome measures
| Measure |
Obinutuzumab + Chlorambucil (GClb)
n=238 Participants
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
|
Chlorambucil (Clb)
n=118 Participants
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
|
|---|---|---|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Social Functioning Scale:Baseline(n=226,110)
|
86.3 unit on a scale
Standard Deviation 22.52
|
83.3 unit on a scale
Standard Deviation 25.34
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Social Functioning Scale: Cy4D1(n=190,93)
|
87.8 unit on a scale
Standard Deviation 19.97
|
85.5 unit on a scale
Standard Deviation 19.38
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Insomnia Scale: Baseline (n=228,111)
|
29.4 unit on a scale
Standard Deviation 31.12
|
31.5 unit on a scale
Standard Deviation 32.98
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Insomnia Scale: Cy4D1(n=189,93)
|
20.6 unit on a scale
Standard Deviation 27.13
|
24.4 unit on a scale
Standard Deviation 29.13
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Appetite Loss Scale: Baseline (n=226, 111)
|
18.1 unit on a scale
Standard Deviation 28.46
|
19.8 unit on a scale
Standard Deviation 29.26
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Appetite Loss Scale: Cy4D1 (n=189, 92)
|
10.2 unit on a scale
Standard Deviation 21.77
|
14.5 unit on a scale
Standard Deviation 24.36
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Cognitive Functioning Scale: Baseline (n=227, 111)
|
80.6 unit on a scale
Standard Deviation 21.35
|
81.8 unit on a scale
Standard Deviation 22.76
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Cognitive Functioning Scale:Cy4D1 (n=190,93)
|
83.9 unit on a scale
Standard Deviation 20.31
|
85.8 unit on a scale
Standard Deviation 18.54
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Constipation Scale: Baseline (n=225, 111)
|
14.8 unit on a scale
Standard Deviation 23.94
|
16.8 unit on a scale
Standard Deviation 26.92
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Constipation Scale: Cy4D1 (n=188, 93)
|
15.1 unit on a scale
Standard Deviation 25.16
|
12.5 unit on a scale
Standard Deviation 23.53
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Diarrhoea Scale: Baseline (n=226, 110)
|
9.3 unit on a scale
Standard Deviation 20.05
|
8.8 unit on a scale
Standard Deviation 18.98
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Diarrhoea Scale: Cy4D1 (n=189, 93)
|
9.3 unit on a scale
Standard Deviation 19.47
|
6.5 unit on a scale
Standard Deviation 14.95
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Dyspnoea Scale: Baseline (n=225, 109)
|
27.1 unit on a scale
Standard Deviation 29.89
|
23.9 unit on a scale
Standard Deviation 27.63
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Dyspnoea: Cy4D1 (n=189, 91)
|
15.9 unit on a scale
Standard Deviation 23.71
|
22.3 unit on a scale
Standard Deviation 26.78
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Emotional Functioning Scale: Baseline (n=226, 111)
|
73.8 unit on a scale
Standard Deviation 23.45
|
72.9 unit on a scale
Standard Deviation 25.7
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Emotional Functioning Scale: Cy4D1(n=190,93)
|
82.5 unit on a scale
Standard Deviation 18.62
|
80.6 unit on a scale
Standard Deviation 18.48
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Fatigue Scale: Baseline (n=226, 111)
|
38 unit on a scale
Standard Deviation 25.72
|
36.9 unit on a scale
Standard Deviation 27.01
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Fatigue Scale: Cy4D1(n=189, 93)
|
29.2 unit on a scale
Standard Deviation 20.39
|
30.8 unit on a scale
Standard Deviation 23.00
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Financial Difficulties Scale: Baseline (n=224,110)
|
8.9 unit on a scale
Standard Deviation 20.69
|
13.6 unit on a scale
Standard Deviation 25.26
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Financial Difficulty Scale: Cy4D1(n=189,93)
|
7.4 unit on a scale
Standard Deviation 17.64
|
9.3 unit on a scale
Standard Deviation 19.88
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Nausea, Vomiting Scale: Baseline (n=227, 111)
|
5 unit on a scale
Standard Deviation 11.18
|
7.4 unit on a scale
Standard Deviation 18.49
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Nausea, Vomiting Scale: Cy4D1 (n=189,93)
|
5.5 unit on a scale
Standard Deviation 11.51
|
7.5 unit on a scale
Standard Deviation 17.81
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Pain scale: Baseline (n=228, 111)
|
22.9 unit on a scale
Standard Deviation 27.57
|
21.5 unit on a scale
Standard Deviation 25.66
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Pain scale: Cy4D1 (n=190, 93)
|
17.9 unit on a scale
Standard Deviation 24.09
|
17.7 unit on a scale
Standard Deviation 25.98
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Physical Functioning Scale: Baseline (n=228, 111)
|
73.7 unit on a scale
Standard Deviation 19.86
|
77.3 unit on a scale
Standard Deviation 18.87
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Physical Functioning Scale: Cy4D1(n=189,93)
|
78.6 unit on a scale
Standard Deviation 18.71
|
80.9 unit on a scale
Standard Deviation 16.24
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Global Health Status Scale: Baseline (n=226, 111)
|
58.4 unit on a scale
Standard Deviation 22.8
|
57.4 unit on a scale
Standard Deviation 22.9
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Global Health Status Scale: Cy4D1(n=189,93)
|
66.7 unit on a scale
Standard Deviation 20.03
|
63.4 unit on a scale
Standard Deviation 20.56
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Role Functioning Scale: Baseline(n=227,110)
|
76.1 unit on a scale
Standard Deviation 26.18
|
74.7 unit on a scale
Standard Deviation 28.35
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score
Role Functioning Scale: Cy4D1(n=189,93)
|
79.7 unit on a scale
Standard Deviation 23.64
|
81.5 unit on a scale
Standard Deviation 21.35
|
SECONDARY outcome
Timeframe: Baseline and Cycle 4 Day 1 (Cy4D1)Population: ITT population. Here, n signifies the number of participants who were evaluated for specified categories.
EORTC Quality of Life Questionnaire (QLQ-CLL16) module was used to assess patient-reported outcomes and symptom burden. The QLQ-CLL16 module includes three multi-item scales assessing fatigue (2 items), treatment side effects and disease symptoms (8 items), infection (4 items) and two single item scales on social activities and future health worries. Final scores are transformed such that they range from 0 - 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.
Outcome measures
| Measure |
Obinutuzumab + Chlorambucil (GClb)
n=238 Participants
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
|
Chlorambucil (Clb)
n=118 Participants
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
|
|---|---|---|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score
Disease Effects Scale: Baseline (n=209, 102)
|
23 unit on a scale
Standard Deviation 18.89
|
23.7 unit on a scale
Standard Deviation 20.18
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score
Disease Effects Scale: Cy4D1 (n=176, 86)
|
15.0 unit on a scale
Standard Deviation 15.12
|
15.9 unit on a scale
Standard Deviation 14.16
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score
Fatigue Scale: Baseline (n=209, 102)
|
31.2 unit on a scale
Standard Deviation 25.83
|
27.6 unit on a scale
Standard Deviation 24.65
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score
Fatigue Scale: Cy4D1 (n=176, 86)
|
20.9 unit on a scale
Standard Deviation 21.51
|
23.4 unit on a scale
Standard Deviation 22.20
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score
Future Health: Baseline (n=206, 101)
|
47.7 unit on a scale
Standard Deviation 32.14
|
50.8 unit on a scale
Standard Deviation 33.53
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score
Future Health: Cy4D1 (n=175, 86)
|
29.5 unit on a scale
Standard Deviation 31.74
|
39.1 unit on a scale
Standard Deviation 30.33
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score
Infection Scale: Baseline (n=209, 102)
|
12 unit on a scale
Standard Deviation 15.91
|
14.6 unit on a scale
Standard Deviation 17.97
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score
Infection Scale: Cy4D1 (n=176, 86)
|
8.9 unit on a scale
Standard Deviation 11.65
|
8.5 unit on a scale
Standard Deviation 10.70
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score
Social Problems: Cy4D1 (n=175, 85)
|
19.4 unit on a scale
Standard Deviation 27.75
|
22.0 unit on a scale
Standard Deviation 27.00
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score
Social Problems: Baseline (n=206, 100)
|
24.3 unit on a scale
Standard Deviation 31.99
|
26.3 unit on a scale
Standard Deviation 33.26
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score
Treatment Side Effects Scale: Baseline (n=209,102)
|
19.8 unit on a scale
Standard Deviation 17.7
|
17.2 unit on a scale
Standard Deviation 15.27
|
|
European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score
Treatment Side Effect Scale: Cy4D1(n=176,86)
|
14.7 unit on a scale
Standard Deviation 14.68
|
15.6 unit on a scale
Standard Deviation 16.11
|
Adverse Events
Obinutuzumab + Chlorambucil (GClb)
Serious events: 113 serious events
Other events: 215 other events
Deaths: 0 deaths
Chlorambucil (Clb)
Serious events: 45 serious events
Other events: 89 other events
Deaths: 0 deaths
Crossover Subjects: Obinutuzumab + Chlorambucil (GClb)
Serious events: 8 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Obinutuzumab + Chlorambucil (GClb)
n=241 participants at risk
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
|
Chlorambucil (Clb)
n=116 participants at risk
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
|
Crossover Subjects: Obinutuzumab + Chlorambucil (GClb)
n=30 participants at risk
Subjects in Clb arm who progressed during/within 6 months after end of Clb treatment had opportunity to cross over to GClb arm at discretion of investigator. Subjects received 1000 mg obinutuzumab IV infusion, on Day 1 \[First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 milligram per kilogram of body weight (mg/kg) orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
|
|---|---|---|---|
|
Infections and infestations
Endocarditis
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Pneumonia
|
4.1%
10/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
3.4%
4/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
3.3%
1/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Respiratory tract infection
|
0.83%
2/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
2.6%
3/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Septic shock
|
0.83%
2/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
1.7%
2/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
3/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Erysipelas
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
1.7%
2/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.83%
2/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Epididymitis
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Neutropenic sepsis
|
1.2%
3/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Sepsis
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
3.4%
4/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
3.3%
1/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Infection
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Liver abscess
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Bronchitis
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Dacryocystitis
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Diverticulitis
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Escherichia sepsis
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Gangrene
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Intervertebral discitis
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Lung infection
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Stenotrophomonas sepsis
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Subcutaneous abscess
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Superinfection bacterial
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Wound infection
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.2%
27/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.83%
2/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.9%
7/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
3.3%
1/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
2.5%
6/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.83%
2/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.2%
3/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid melanoma
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraocular melanoma
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.83%
2/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.83%
2/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial spreading melanoma stage unspecified
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.83%
2/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
4.3%
5/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
3.3%
1/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
3/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
1.7%
2/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.2%
3/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.83%
2/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Cardiac disorders
Myocardial infarction
|
1.7%
4/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
1.7%
2/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Cardiac disorders
Cardiac failure
|
1.2%
3/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
1.7%
2/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Cardiac disorders
Atrial fibrillation
|
0.83%
2/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Cardiac disorders
Atrial thrombosis
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Cardiac disorders
Nodal rhythm
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.83%
2/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Gastrointestinal disorders
Ascites
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Gastrointestinal disorders
Colitis
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Gastrointestinal disorders
Gastritis
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Gastrointestinal disorders
Thrombosis mesenteric vessel
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.2%
3/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Nervous system disorders
Syncope
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Nervous system disorders
Central nervous system haemorrhage
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Vascular disorders
Deep vein thrombosis
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Vascular disorders
Capillary leak syndrome
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Vascular disorders
Diabetic macroangiopathy
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Vascular disorders
Dry gangrene
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
General disorders
Chest pain
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
General disorders
Asthenia
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
General disorders
Death
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
General disorders
Fatigue
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
General disorders
General physical health deterioration
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
General disorders
Impaired healing
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
General disorders
Malaise
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
General disorders
Pyrexia
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.83%
2/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.83%
2/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
1.2%
3/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Hepatobiliary disorders
Liver disorder
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Congenital, familial and genetic disorders
Hereditary non-polyposis colorectal cancer syndrome
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Reproductive system and breast disorders
Testicular hypertrophy
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Immune system disorders
Anaphylactic reaction
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Investigations
Platelet count decreased
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Surgical and medical procedures
Fracture treatment
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.86%
1/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous Carcinoma of Skin
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Cancer
|
0.41%
1/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
3.3%
1/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
3.3%
1/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
3.3%
1/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
3.3%
1/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
3.3%
1/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Nervous system disorders
Major depression
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
3.3%
1/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
Other adverse events
| Measure |
Obinutuzumab + Chlorambucil (GClb)
n=241 participants at risk
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
|
Chlorambucil (Clb)
n=116 participants at risk
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
|
Crossover Subjects: Obinutuzumab + Chlorambucil (GClb)
n=30 participants at risk
Subjects in Clb arm who progressed during/within 6 months after end of Clb treatment had opportunity to cross over to GClb arm at discretion of investigator. Subjects received 1000 mg obinutuzumab IV infusion, on Day 1 \[First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 milligram per kilogram of body weight (mg/kg) orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
41.1%
99/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
18.1%
21/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
40.0%
12/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.9%
36/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
7.8%
9/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
23.3%
7/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Blood and lymphatic system disorders
Anaemia
|
11.2%
27/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
10.3%
12/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
10.0%
3/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.1%
17/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
16.7%
5/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
32/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
25.0%
29/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
10.0%
3/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.5%
23/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
11.2%
13/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
10.0%
3/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
17/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
10.3%
12/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
6.7%
2/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
13/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
12.1%
14/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
61.0%
147/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
50.0%
15/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
General disorders
Pyrexia
|
10.4%
25/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
6.9%
8/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
6.7%
2/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
General disorders
Fatigue
|
6.6%
16/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
10.3%
12/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
3.3%
1/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
General disorders
Asthenia
|
7.1%
17/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
6.9%
8/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
3.3%
1/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
22/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
6.9%
8/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
13.3%
4/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
5/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
6.9%
8/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
6.7%
2/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Bronchitis
|
4.1%
10/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
6.9%
8/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
3.3%
1/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Nervous system disorders
Headache
|
7.9%
19/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
6.9%
8/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.3%
8/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
7.8%
9/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
6.7%
2/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Urinary tract infection
|
5.8%
14/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
1.7%
2/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infections
|
5.8%
14/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
5.2%
6/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/241 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
0.00%
0/116 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
6.7%
2/30 • Randomization to clinical cutoff (median observation 42 months)
Safety population included patients who received at least 1 dose of study drug. Adverse Events are reported for Stage 1a (GClb and Clb arms). In Stage 1a, 4 patients randomized to the RClb arm actually received obinutuzumab and were included in the GClb arm for analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER