Trial Outcomes & Findings for Ofatumumab vs Physician's Choice in Subjects With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukemia (NCT NCT01313689)
NCT ID: NCT01313689
Last Updated: 2018-11-08
Results Overview
PFS is the interval of time between the date of first randomization to the date of disease progression (PD) or death due to any reason, whichever occurred first. The date of PD was defined as the first occurrence of any criteria of progression. PD criteria requires at least one of the following: progression of lymphadenopathy, \>=50% increase in liver or spleen size, \>=50% increase in number of lymphocytes per microliter, more aggressive histology, occurence of cytopenia after treatment attributable to CLL. Disease progression was determined according to the 2008 International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) update of the National Cancer Institute-sponsored Working Group CLL Guidelines for Response (NCI-WG). PFS was censored at the time of the last follow up for participants who have neither progressed or died.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
122 participants
Primary outcome timeframe
From the randomization date up to 60 months post the randomization date.
Results posted on
2018-11-08
Participant Flow
Note: The 'Total Participants' in the Baseline Characteristics Table and in most of the Efficacy results Tables should be either Any OFA + Physician's Choice or OFA extended + OFA observation + OFA + Physician's Choice instead of the automatic calculated Total number indicated.
Participants(par) were randomized to receive an Open-Label treatment(trt) of ofatumumab(OFA) or a physicians choice(PC) trt for up to 24 weeks. OFA par without progressive disease(PD) underwent a second randomization to receive an additional 24 weeks of OFA or no further trt. PC par who developed PD had the option to receive OFA salvage therapy.
Participant milestones
| Measure |
Any Ofatumumab
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Physician's Choice (PC)
Par. randomized to receive PC trt during Randomization 1 were admin. treatments approved for Chronic Lymphocytic Leukaemia (CLL) \& well-established standards of care as prescribed with standard dose \& route. Experimental therapies or any doses beyond approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for max. trt duration of 48 weeks. Par. entered Follow-up after OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status \& anti-cancer therapy information was collected in the SFU. Par. did not receive OFA salvage trt \& demonstrated PD, entered SFU.Of 43 par 22 went to OFA salvage arm.
|
Ofatumumab Extended (OFA Ext)
Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab Observation (OFA Observ.)
Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA First Randomization Only (OFA FRO)
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.
Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
|---|---|---|---|---|---|
|
24-Week Randomization 1
STARTED
|
79
|
43
|
0
|
0
|
0
|
|
24-Week Randomization 1
COMPLETED
|
60
|
33
|
0
|
0
|
0
|
|
24-Week Randomization 1
NOT COMPLETED
|
19
|
10
|
0
|
0
|
0
|
|
24-Week Randomization 2
STARTED
|
0
|
0
|
24
|
13
|
42
|
|
24-Week Randomization 2
COMPLETED
|
0
|
0
|
21
|
12
|
27
|
|
24-Week Randomization 2
NOT COMPLETED
|
0
|
0
|
3
|
1
|
15
|
Reasons for withdrawal
| Measure |
Any Ofatumumab
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Physician's Choice (PC)
Par. randomized to receive PC trt during Randomization 1 were admin. treatments approved for Chronic Lymphocytic Leukaemia (CLL) \& well-established standards of care as prescribed with standard dose \& route. Experimental therapies or any doses beyond approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for max. trt duration of 48 weeks. Par. entered Follow-up after OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status \& anti-cancer therapy information was collected in the SFU. Par. did not receive OFA salvage trt \& demonstrated PD, entered SFU.Of 43 par 22 went to OFA salvage arm.
|
Ofatumumab Extended (OFA Ext)
Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab Observation (OFA Observ.)
Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA First Randomization Only (OFA FRO)
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.
Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
|---|---|---|---|---|---|
|
24-Week Randomization 1
Adverse Event
|
10
|
5
|
0
|
0
|
0
|
|
24-Week Randomization 1
Physician Decision
|
4
|
5
|
0
|
0
|
0
|
|
24-Week Randomization 1
Withdrawal by Subject
|
5
|
0
|
0
|
0
|
0
|
|
24-Week Randomization 2
Adverse Event
|
0
|
0
|
2
|
0
|
8
|
|
24-Week Randomization 2
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
3
|
|
24-Week Randomization 2
Physician Decision
|
0
|
0
|
0
|
0
|
4
|
Baseline Characteristics
The Intent-to-Treat (ITT) population included subjects who were randomized.
Baseline characteristics by cohort
| Measure |
Any Ofatumumab (OFA)
n=79 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Physician's Choice (PC)
n=43 Participants
Par. randomized to receive PC trt during Randomization 1 were admin. treatments approved for Chronic Lymphocytic Leukaemia (CLL) \& well-established standards of care as prescribed with standard dose \& route. Experimental therapies or any doses beyond approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for max. trt duration of 48 weeks. Par. entered Follow-up after OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status \& anti-cancer therapy information was collected in the SFU. Par. did not receive OFA salvage trt \& demonstrated PD, entered SFU.Of 43 par 22 went to OFA salvage arm.
|
Ofatumumab Extended (OFA Ext)
n=24 Participants
Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab Observation (OFA Observ.)
n=13 Participants
Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA First Randomization Only (OFA FRO)
n=42 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.
Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.3 Years
STANDARD_DEVIATION 8.95 • n=93 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
61.8 Years
STANDARD_DEVIATION 9.87 • n=4 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
61.7 Years
STANDARD_DEVIATION 9.09 • n=27 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
66.7 Years
STANDARD_DEVIATION 5.99 • n=483 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
63.2 Years
STANDARD_DEVIATION 9.52 • n=36 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
62.8 Years
STANDARD_DEVIATION 9.28 • n=10 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
|
Sex: Female, Male
Female
|
24 Participants
n=93 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
14 Participants
n=4 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
9 Participants
n=27 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
2 Participants
n=483 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
13 Participants
n=36 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
62 Participants
n=10 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
|
Sex: Female, Male
Male
|
55 Participants
n=93 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
29 Participants
n=4 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
15 Participants
n=27 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
11 Participants
n=483 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
29 Participants
n=36 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
139 Participants
n=10 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=93 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
0 Participants
n=4 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
0 Participants
n=27 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
0 Participants
n=483 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
1 Participants
n=36 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
2 Participants
n=10 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
78 Participants
n=93 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
43 Participants
n=4 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
24 Participants
n=27 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
13 Participants
n=483 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
41 Participants
n=36 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
199 Participants
n=10 Participants • The Intent-to-Treat (ITT) population included subjects who were randomized.
|
PRIMARY outcome
Timeframe: From the randomization date up to 60 months post the randomization date.Population: Intent-to-treat (ITT) population: all participants who were randomised to receive OFA or PC at the first randomisation.
PFS is the interval of time between the date of first randomization to the date of disease progression (PD) or death due to any reason, whichever occurred first. The date of PD was defined as the first occurrence of any criteria of progression. PD criteria requires at least one of the following: progression of lymphadenopathy, \>=50% increase in liver or spleen size, \>=50% increase in number of lymphocytes per microliter, more aggressive histology, occurence of cytopenia after treatment attributable to CLL. Disease progression was determined according to the 2008 International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) update of the National Cancer Institute-sponsored Working Group CLL Guidelines for Response (NCI-WG). PFS was censored at the time of the last follow up for participants who have neither progressed or died.
Outcome measures
| Measure |
Any Ofatumumab (OFA)
n=79 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Physician's Choice (PC)
n=43 Participants
Par. randomized to receive PC trt during Randomization 1 were admin. treatments approved for Chronic Lymphocytic Leukaemia (CLL) \& well-established standards of care as prescribed with standard dose \& route. Experimental therapies or any doses beyond approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for max. trt duration of 48 weeks. Par. entered Follow-up after OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status \& anti-cancer therapy information was collected in the SFU. Par. did not receive OFA salvage trt \& demonstrated PD, entered SFU.Of 43 par 22 went to OFA salvage arm.
|
Ofatumumab Extended (OFA Ext)
n=24 Participants
Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab Observation (OFA Observ.)
n=13 Participants
These participants came from the Physicia's Choice (PC) arm. Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA First Randomization Only (OFA FRO)
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.
Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA Salvage
The participants in this arm are from the Physician's Choice (PC) arm. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC)
|
5.36 Months
Interval 4.3 to 6.97
|
3.61 Months
Interval 1.87 to 6.74
|
10.05 Months
Interval 7.23 to 13.8
|
7.16 Months
Interval 5.36 to 9.49
|
—
|
—
|
SECONDARY outcome
Timeframe: From the randomization date up to 60 months post the randomization date.Population: Intent-to-treat (ITT) population: all participants who were randomised to receive OFA or PC at the first randomisation.
PFS is the interval of time between the date of first randomization to the date of disease progression (PD) or death due to any reason, whichever occurred first. The date of PD was defined as the first occurrence of any criteria of progression. PD criteria requires at least one of the following: progression of lymphadenopathy, \>=50% increase in liver or spleen size, \>=50% increase in number of lymphocytes per microliter, more aggressive histology, occurence of cytopenia after treatment attributable to CLL. Disease progression was determined according to the 2008 International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) update of the National Cancer Institute-sponsored Working Group CLL Guidelines for Response (NCI-WG). PFS was censored at the time of the last follow up for participants who have neither progressed or died.
Outcome measures
| Measure |
Any Ofatumumab (OFA)
n=79 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Physician's Choice (PC)
n=43 Participants
Par. randomized to receive PC trt during Randomization 1 were admin. treatments approved for Chronic Lymphocytic Leukaemia (CLL) \& well-established standards of care as prescribed with standard dose \& route. Experimental therapies or any doses beyond approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for max. trt duration of 48 weeks. Par. entered Follow-up after OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status \& anti-cancer therapy information was collected in the SFU. Par. did not receive OFA salvage trt \& demonstrated PD, entered SFU.Of 43 par 22 went to OFA salvage arm.
|
Ofatumumab Extended (OFA Ext)
n=24 Participants
Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab Observation (OFA Observ.)
n=13 Participants
These participants came from the Physicia's Choice (PC) arm. Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA First Randomization Only (OFA FRO)
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.
Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA Salvage
The participants in this arm are from the Physician's Choice (PC) arm. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) as Assessed by Investigator
|
7.00 Months
Interval 5.42 to 8.25
|
4.50 Months
Interval 1.97 to 5.62
|
12.68 Months
Interval 10.09 to 14.29
|
9.49 Months
Interval 7.0 to 12.12
|
—
|
—
|
SECONDARY outcome
Timeframe: From the randomization date up to 60 months post the randomization date.Population: ITT Population. Not evaluable is defined as insufficient data present to classify into one of the other categories.
ORR is defined as the number of participants achieving either complete response (CR) or partial response (PR). ORR was measured using the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria: no lymphadenopathy(Ly)/ hepatomegaly, splenomegaly, constitutional symptoms; neutrophils \>1500 per microliter(µL), platelets(PL) \>100,000/µL, hemoglobin(Hb) \>11 grams/deciliter(g/dL), lymphocytes(LC) \<4000/µL, bone marrow(BM) sample must be normocellular for age, \<30% LC and no lymphoid nodules. PR requires the following criteria for at least 2 months: \>=50% decrease in LC, reduction in Ly (i.e., \>=50% decrease in lymph node size or no increase or new lymph nodes), \>=50% decrease in the size of liver and spleen and at least one of the following results: PL \>100,000/µL or 50% improvement over Baseline(BL), Hb \>11 g/dL or 50% improvement over BL, neutrophils\>1500/μL. Nodular PR (nPR) indicates persistent nodules in the BM.
Outcome measures
| Measure |
Any Ofatumumab (OFA)
n=79 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Physician's Choice (PC)
n=43 Participants
Par. randomized to receive PC trt during Randomization 1 were admin. treatments approved for Chronic Lymphocytic Leukaemia (CLL) \& well-established standards of care as prescribed with standard dose \& route. Experimental therapies or any doses beyond approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for max. trt duration of 48 weeks. Par. entered Follow-up after OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status \& anti-cancer therapy information was collected in the SFU. Par. did not receive OFA salvage trt \& demonstrated PD, entered SFU.Of 43 par 22 went to OFA salvage arm.
|
Ofatumumab Extended (OFA Ext)
n=24 Participants
Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab Observation (OFA Observ.)
n=13 Participants
These participants came from the Physicia's Choice (PC) arm. Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA First Randomization Only (OFA FRO)
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.
Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA Salvage
The participants in this arm are from the Physician's Choice (PC) arm. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) as Assessed by the IRC
PR
|
30 Participants
|
7 Participants
|
18 Participants
|
8 Participants
|
—
|
—
|
|
Overall Response Rate (ORR) as Assessed by the IRC
nPR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Overall Response Rate (ORR) as Assessed by the IRC
Stable Disease
|
36 Participants
|
22 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
|
Overall Response Rate (ORR) as Assessed by the IRC
Not Evaluable
|
4 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Overall Response Rate (ORR) as Assessed by the IRC
Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Overall Response Rate (ORR) as Assessed by the IRC
CR
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Overall Response Rate (ORR) as Assessed by the IRC
Progressive Disease
|
9 Participants
|
8 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From the randomization date up to 60 months post the randomization date.Population: ITT Population. Not evaluable is defined as insufficient data present to classify into one of the other categories.
ORR is defined as the number of participants achieving either complete response (CR) or partial response (PR). Overall response was measured using the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria: no lymphadenopathy(Ly)/ hepatomegaly, splenomegaly, constitutional symptoms; neutrophils \>1500 per microliter(µL), platelets(PL) \>100,000/µL, hemoglobin(Hb) \>11 grams/deciliter(g/dL), lymphocytes(LC) \<4000/µL, bone marrow(BM) sample must be normocellular for age, \<30% LC and no lymphoid nodules. PR requires the following criteria for at least 2 months: \>=50% decrease in LC, reduction in Ly (i.e., \>=50% decrease in lymph node size or no increase or new lymph nodes), \>=50% decrease in the size of liver and spleen and at least one of the following results: PL \>100,000/µL or 50% improvement over Baseline(BL), Hb \>11 g/dL or 50% improvement over BL, neutrophils\>1500/μL. Nodular PR (nPR) indicates persistent nodules in the BM.
Outcome measures
| Measure |
Any Ofatumumab (OFA)
n=79 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Physician's Choice (PC)
n=43 Participants
Par. randomized to receive PC trt during Randomization 1 were admin. treatments approved for Chronic Lymphocytic Leukaemia (CLL) \& well-established standards of care as prescribed with standard dose \& route. Experimental therapies or any doses beyond approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for max. trt duration of 48 weeks. Par. entered Follow-up after OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status \& anti-cancer therapy information was collected in the SFU. Par. did not receive OFA salvage trt \& demonstrated PD, entered SFU.Of 43 par 22 went to OFA salvage arm.
|
Ofatumumab Extended (OFA Ext)
n=24 Participants
Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab Observation (OFA Observ.)
n=13 Participants
These participants came from the Physicia's Choice (PC) arm. Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA First Randomization Only (OFA FRO)
n=42 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.
Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA Salvage
The participants in this arm are from the Physician's Choice (PC) arm. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) as Assessed by the Investigator
PR
|
36 Participants
|
12 Participants
|
17 Participants
|
7 Participants
|
12 Participants
|
—
|
|
Overall Response Rate (ORR) as Assessed by the Investigator
nPR
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Response Rate (ORR) as Assessed by the Investigator
Stable Disease
|
34 Participants
|
14 Participants
|
6 Participants
|
4 Participants
|
24 Participants
|
—
|
|
Overall Response Rate (ORR) as Assessed by the Investigator
Not Evaluable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Overall Response Rate (ORR) as Assessed by the Investigator
Missing
|
4 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
—
|
|
Overall Response Rate (ORR) as Assessed by the Investigator
CR
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Overall Response Rate (ORR) as Assessed by the Investigator
Progressive Disease
|
2 Participants
|
10 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: From the randomization date up to 60 months post the randomization date.Population: ITT population. Only those participants with data available were analyzed, participants who had not died were censored at the date of last contact.
Overall survival (OS) is defined as the time from randomization to death due to any cause. Kaplan-Meier plots were used to estimate the reported median OS time.
Outcome measures
| Measure |
Any Ofatumumab (OFA)
n=79 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Physician's Choice (PC)
n=43 Participants
Par. randomized to receive PC trt during Randomization 1 were admin. treatments approved for Chronic Lymphocytic Leukaemia (CLL) \& well-established standards of care as prescribed with standard dose \& route. Experimental therapies or any doses beyond approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for max. trt duration of 48 weeks. Par. entered Follow-up after OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status \& anti-cancer therapy information was collected in the SFU. Par. did not receive OFA salvage trt \& demonstrated PD, entered SFU.Of 43 par 22 went to OFA salvage arm.
|
Ofatumumab Extended (OFA Ext)
n=24 Participants
Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab Observation (OFA Observ.)
n=13 Participants
These participants came from the Physicia's Choice (PC) arm. Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA First Randomization Only (OFA FRO)
n=42 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.
Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA Salvage
The participants in this arm are from the Physician's Choice (PC) arm. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
|---|---|---|---|---|---|---|
|
Overall Survival
|
19.19 Months
Interval 12.19 to 29.11
|
14.52 Months
Interval 8.94 to 24.97
|
31.54 Months
Interval 19.19 to 51.25
|
45.50 Months
Interval 14.69 to
N/A = The upper limit of the 95% CI is not available due to the sparcity of the data.
|
8.57 Months
Interval 4.93 to 16.76
|
—
|
SECONDARY outcome
Timeframe: From the randomization date up to 60 months post the randomization date.Population: ITT population. Only those participants with data available were analyzed.
Time to progression is defined as the time from the date of randomization to disease progression (PD). PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (\>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Participants who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time were censored at the date of the last visit with adequate assessment.
Outcome measures
| Measure |
Any Ofatumumab (OFA)
n=56 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Physician's Choice (PC)
n=23 Participants
Par. randomized to receive PC trt during Randomization 1 were admin. treatments approved for Chronic Lymphocytic Leukaemia (CLL) \& well-established standards of care as prescribed with standard dose \& route. Experimental therapies or any doses beyond approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for max. trt duration of 48 weeks. Par. entered Follow-up after OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status \& anti-cancer therapy information was collected in the SFU. Par. did not receive OFA salvage trt \& demonstrated PD, entered SFU.Of 43 par 22 went to OFA salvage arm.
|
Ofatumumab Extended (OFA Ext)
n=19 Participants
Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab Observation (OFA Observ.)
n=11 Participants
These participants came from the Physicia's Choice (PC) arm. Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA First Randomization Only (OFA FRO)
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.
Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA Salvage
The participants in this arm are from the Physician's Choice (PC) arm. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
|---|---|---|---|---|---|---|
|
Time to Progression as Assessed by IRC
|
6.31 Months
Interval 4.83 to 7.33
|
5.32 Months
Interval 2.14 to 8.08
|
10.05 Months
Interval 7.23 to 13.8
|
7.16 Months
Interval 5.36 to 9.49
|
—
|
—
|
SECONDARY outcome
Timeframe: From the randomization date up to 60 months post the randomization date.Population: ITT population. Only those participants with data available were analyzed.
Time to next therapy is defined as the time from randomization until the start of the next line of treatment.
Outcome measures
| Measure |
Any Ofatumumab (OFA)
n=44 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Physician's Choice (PC)
n=29 Participants
Par. randomized to receive PC trt during Randomization 1 were admin. treatments approved for Chronic Lymphocytic Leukaemia (CLL) \& well-established standards of care as prescribed with standard dose \& route. Experimental therapies or any doses beyond approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for max. trt duration of 48 weeks. Par. entered Follow-up after OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status \& anti-cancer therapy information was collected in the SFU. Par. did not receive OFA salvage trt \& demonstrated PD, entered SFU.Of 43 par 22 went to OFA salvage arm.
|
Ofatumumab Extended (OFA Ext)
n=12 Participants
Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab Observation (OFA Observ.)
n=12 Participants
These participants came from the Physicia's Choice (PC) arm. Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA First Randomization Only (OFA FRO)
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.
Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA Salvage
The participants in this arm are from the Physician's Choice (PC) arm. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
|---|---|---|---|---|---|---|
|
Time to Next Anti-cancer Therapy by Investigator
|
11.50 Months
Interval 8.51 to 13.8
|
6.54 Months
Interval 2.66 to 8.08
|
15.47 Months
Interval 11.86 to
The upper limit of the 95% CI is not available due to the sparcity of the data.
|
9.00 Months
Interval 8.08 to 14.16
|
—
|
—
|
SECONDARY outcome
Timeframe: From the randomization date up to 60 months post the randomization date.Population: ITT population. Only responders (CR, CRi, PR, nPR) were included in the analysis. Response was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008.
Time to response is defined as the time from randomization to the first response (Complete Remission\[CR\], Complete Remission with incomplete bone marrow recovery\[CRi\], partial response\[PR\], or nodular PR\[nPR\]). CR(all the criteria at least 2 months after last treatment): no lymphadenopathy(Ly) \> 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils \>1500 per microliter(µL), platelets(PL) \>100,000/µL, hemoglobin(Hb) \>11 grams/deciliter(g/dL), lymphocytes(LC) \<4000/µL, bone marrow(BM) sample must be normocellular for age, \<30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: \>=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL \>100,000/µL or 50% improvement over Baseline(BL), Hb \>11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. Participants with unknown or missing responses were considered as non-responders.
Outcome measures
| Measure |
Any Ofatumumab (OFA)
n=30 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Physician's Choice (PC)
n=7 Participants
Par. randomized to receive PC trt during Randomization 1 were admin. treatments approved for Chronic Lymphocytic Leukaemia (CLL) \& well-established standards of care as prescribed with standard dose \& route. Experimental therapies or any doses beyond approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for max. trt duration of 48 weeks. Par. entered Follow-up after OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status \& anti-cancer therapy information was collected in the SFU. Par. did not receive OFA salvage trt \& demonstrated PD, entered SFU.Of 43 par 22 went to OFA salvage arm.
|
Ofatumumab Extended (OFA Ext)
n=18 Participants
Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab Observation (OFA Observ.)
n=8 Participants
These participants came from the Physicia's Choice (PC) arm. Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA First Randomization Only (OFA FRO)
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.
Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA Salvage
The participants in this arm are from the Physician's Choice (PC) arm. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
|---|---|---|---|---|---|---|
|
Time to Response as Assessed by the IRC
|
1.17 Months
Interval 1.02 to 1.91
|
2.56 Months
Interval 0.76 to 3.48
|
1.86 Months
Interval 1.05 to 1.94
|
1.15 Months
Interval 0.92 to 1.94
|
—
|
—
|
SECONDARY outcome
Timeframe: From the randomization date up to 60 months post the randomization date.Population: ITT population. Only those participants with data available at the indicated time points were analyzed. Only responders (CR, CRi, PR, nPR) were included in the analysis.
DOR is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (\>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Par. who were alive and had not progressed at the time of analysis or if a progression event occurred after extensive lost-to-follow-up time (\>= 12 weeks) were censored at the date of the last visit with adequate assessment. Par. with unknown or missing responses were considered as non-responders.
Outcome measures
| Measure |
Any Ofatumumab (OFA)
n=23 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Physician's Choice (PC)
n=5 Participants
Par. randomized to receive PC trt during Randomization 1 were admin. treatments approved for Chronic Lymphocytic Leukaemia (CLL) \& well-established standards of care as prescribed with standard dose \& route. Experimental therapies or any doses beyond approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for max. trt duration of 48 weeks. Par. entered Follow-up after OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status \& anti-cancer therapy information was collected in the SFU. Par. did not receive OFA salvage trt \& demonstrated PD, entered SFU.Of 43 par 22 went to OFA salvage arm.
|
Ofatumumab Extended (OFA Ext)
Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab Observation (OFA Observ.)
These participants came from the Physicia's Choice (PC) arm. Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA First Randomization Only (OFA FRO)
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.
Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA Salvage
The participants in this arm are from the Physician's Choice (PC) arm. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
|---|---|---|---|---|---|---|
|
Duration of Response as Assessed by the IRC
|
6.24 Months
Interval 5.32 to 12.22
|
6.95 Months
Interval 4.47 to
The upper limit of the 95% CI is not available due to the sparcity of the data.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapyPopulation: Safety Population: all participants who received at least one dose of any study treatment (OFA or PC) at the first randomization.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect.
Outcome measures
| Measure |
Any Ofatumumab (OFA)
n=78 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Physician's Choice (PC)
n=43 Participants
Par. randomized to receive PC trt during Randomization 1 were admin. treatments approved for Chronic Lymphocytic Leukaemia (CLL) \& well-established standards of care as prescribed with standard dose \& route. Experimental therapies or any doses beyond approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for max. trt duration of 48 weeks. Par. entered Follow-up after OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status \& anti-cancer therapy information was collected in the SFU. Par. did not receive OFA salvage trt \& demonstrated PD, entered SFU.Of 43 par 22 went to OFA salvage arm.
|
Ofatumumab Extended (OFA Ext)
n=24 Participants
Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab Observation (OFA Observ.)
n=13 Participants
These participants came from the Physicia's Choice (PC) arm. Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA First Randomization Only (OFA FRO)
n=41 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.
Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA Salvage
n=22 Participants
The participants in this arm are from the Physician's Choice (PC) arm. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Any Adverse Event (AE), Any Serious Adverse Event (SAE), Any Fatal Serious Adverse Event (FSAE), or Deaths
Any AE
|
71 Participants
|
37 Participants
|
22 Participants
|
10 Participants
|
39 Participants
|
20 Participants
|
|
Number of Participants With Any Adverse Event (AE), Any Serious Adverse Event (SAE), Any Fatal Serious Adverse Event (FSAE), or Deaths
Any FSAE
|
14 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
5 Participants
|
|
Number of Participants With Any Adverse Event (AE), Any Serious Adverse Event (SAE), Any Fatal Serious Adverse Event (FSAE), or Deaths
Deaths
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Any Adverse Event (AE), Any Serious Adverse Event (SAE), Any Fatal Serious Adverse Event (FSAE), or Deaths
Any SAE
|
43 Participants
|
23 Participants
|
12 Participants
|
5 Participants
|
26 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapyPopulation: Safety Population: all participants who received at least one dose of any study treatment (OFA or PC) at the first randomization.
AEs of special interest included cytopenias (neutropenia \[decreased neutrophil count\], anaemia \[decreased hemoglobin\], and thrombocytopenia \[decreased platelet count\]), autoimmune haematologic complications (autoimmune haemolytic anaemia and haemolytic anaemia), infusion reactions, infections, mucocutaneous reactions, Tumour Lysis Syndrome (TLS), cardiovascular events, and small bowel obstruction.
Outcome measures
| Measure |
Any Ofatumumab (OFA)
n=78 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Physician's Choice (PC)
n=43 Participants
Par. randomized to receive PC trt during Randomization 1 were admin. treatments approved for Chronic Lymphocytic Leukaemia (CLL) \& well-established standards of care as prescribed with standard dose \& route. Experimental therapies or any doses beyond approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for max. trt duration of 48 weeks. Par. entered Follow-up after OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status \& anti-cancer therapy information was collected in the SFU. Par. did not receive OFA salvage trt \& demonstrated PD, entered SFU.Of 43 par 22 went to OFA salvage arm.
|
Ofatumumab Extended (OFA Ext)
n=24 Participants
Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab Observation (OFA Observ.)
n=13 Participants
These participants came from the Physicia's Choice (PC) arm. Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA First Randomization Only (OFA FRO)
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.
Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA Salvage
The participants in this arm are from the Physician's Choice (PC) arm. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Any Adverse Event (AE) of Special Interest
Any AE of TLS
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Any Adverse Event (AE) of Special Interest
Any AE of cardiovascular events
|
13 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Any Adverse Event (AE) of Special Interest
Any AE of decreased neutrophil count
|
23 Participants
|
15 Participants
|
11 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Any Adverse Event (AE) of Special Interest
Any AE of autoimmune haemolytic anaemia
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Any Adverse Event (AE) of Special Interest
Any infusion related AE
|
33 Participants
|
11 Participants
|
8 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Any Adverse Event (AE) of Special Interest
Any AE of decreased hemoglobin
|
9 Participants
|
9 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Any Adverse Event (AE) of Special Interest
Any AE of decreased platelet count
|
10 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Any Adverse Event (AE) of Special Interest
Any AE of haemolytic anaemia
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Any Adverse Event (AE) of Special Interest
Any AE of mucocutaneous reaction
|
20 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Any Adverse Event (AE) of Special Interest
Any AE of Infection
|
46 Participants
|
24 Participants
|
16 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Any Adverse Event (AE) of Special Interest
Any AE of small bowel obstruction
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening and every 3 months during treatment, every 6 months after last treatment until PD or until 42 Month Follow-up VisitPopulation: Safety Population: all participants who received at least one dose of any study treatment (OFA or PC) at the first randomization.
Immunoglobulins or antibodies are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Immunoglobulin testing was performed at Screening (SCR), Cycle 3 Week 4 (C3W4), Cycle 7 Week 4 (C3W4) ,Cycle 9 Week 4 (C3W4), 6 Month Follow-up Visit (6M FU), 9 Month Follow-up (9M FU), 12 Month Follow-up (12M FU), 18 Month Follow-up (18M FU), 24 Month Follow-up (24M FU), 30 Month Follow-up (30M FU), 36 Month Follow-up (36M FU), 42 Month Follow-up (42M FU). A cycle is defined as the time between one round of treatment until the start of the next round.
Outcome measures
| Measure |
Any Ofatumumab (OFA)
n=78 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Physician's Choice (PC)
n=43 Participants
Par. randomized to receive PC trt during Randomization 1 were admin. treatments approved for Chronic Lymphocytic Leukaemia (CLL) \& well-established standards of care as prescribed with standard dose \& route. Experimental therapies or any doses beyond approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for max. trt duration of 48 weeks. Par. entered Follow-up after OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status \& anti-cancer therapy information was collected in the SFU. Par. did not receive OFA salvage trt \& demonstrated PD, entered SFU.Of 43 par 22 went to OFA salvage arm.
|
Ofatumumab Extended (OFA Ext)
n=24 Participants
Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab Observation (OFA Observ.)
n=13 Participants
These participants came from the Physicia's Choice (PC) arm. Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA First Randomization Only (OFA FRO)
n=41 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.
Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA Salvage
n=22 Participants
The participants in this arm are from the Physician's Choice (PC) arm. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
|---|---|---|---|---|---|---|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgA, SCR
|
0.793 Gram per liter
Standard Deviation 0.6680
|
0.685 Gram per liter
Standard Deviation 0.5518
|
0.807 Gram per liter
Standard Deviation 0.7426
|
1.095 Gram per liter
Standard Deviation 0.7535
|
0.688 Gram per liter
Standard Deviation 0.5749
|
—
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgA, C3W4
|
0.721 Gram per liter
Standard Deviation 0.6355
|
0.675 Gram per liter
Standard Deviation 0.4819
|
0.808 Gram per liter
Standard Deviation 0.7931
|
0.977 Gram per liter
Standard Deviation 0.6458
|
0.514 Gram per liter
Standard Deviation 0.3621
|
0.486 Gram per liter
Standard Deviation 0.3868
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgG, C3W4
|
5.925 Gram per liter
Standard Deviation 3.5059
|
5.481 Gram per liter
Standard Deviation 2.1226
|
5.949 Gram per liter
Standard Deviation 3.4089
|
7.232 Gram per liter
Standard Deviation 4.0103
|
5.276 Gram per liter
Standard Deviation 3.3056
|
5.974 Gram per liter
Standard Deviation 2.7992
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgM, C3W4
|
0.692 Gram per liter
Standard Deviation 1.3420
|
0.485 Gram per liter
Standard Deviation 0.4929
|
0.882 Gram per liter
Standard Deviation 1.9833
|
0.429 Gram per liter
Standard Deviation 0.3497
|
0.636 Gram per liter
Standard Deviation 0.7764
|
0.488 Gram per liter
Standard Deviation 0.4816
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgA, C7W4
|
0.793 Gram per liter
Standard Deviation 0.6608
|
—
|
0.723 Gram per liter
Standard Deviation 0.6730
|
0.945 Gram per liter
Standard Deviation 0.6724
|
0.725 Gram per liter
Standard Deviation 0.6011
|
0.537 Gram per liter
Standard Deviation 0.4356
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgM, C7W4
|
0.762 Gram per liter
Standard Deviation 1.7523
|
—
|
0.844 Gram per liter
Standard Deviation 2.1136
|
0.414 Gram per liter
Standard Deviation 0.3400
|
1.865 Gram per liter
Standard Deviation 2.3547
|
0.447 Gram per liter
Standard Deviation 0.4732
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgA, C9W4
|
0.719 Gram per liter
Standard Deviation 0.6336
|
—
|
0.630 Gram per liter
Standard Deviation 0.6005
|
0.952 Gram per liter
Standard Deviation 0.6997
|
—
|
0.567 Gram per liter
Standard Deviation 0.3968
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgM, C9W4
|
0.853 Gram per liter
Standard Deviation 2.3484
|
—
|
0.973 Gram per liter
Standard Deviation 2.7574
|
0.536 Gram per liter
Standard Deviation 0.4209
|
—
|
0.484 Gram per liter
Standard Deviation 0.4493
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgA, 12M FU
|
0.721 Gram per liter
Standard Deviation 0.8339
|
0.983 Gram per liter
Standard Deviation 0.6029
|
0.826 Gram per liter
Standard Deviation 0.9960
|
0.477 Gram per liter
Standard Deviation 0.1595
|
—
|
0.300 Gram per liter
Standard Deviation 0.000
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgG, 12M FU
|
6.423 Gram per liter
Standard Deviation 3.5390
|
7.497 Gram per liter
Standard Deviation 1.5550
|
7.621 Gram per liter
Standard Deviation 3.3834
|
3.627 Gram per liter
Standard Deviation 2.2938
|
—
|
4.935 Gram per liter
Standard Deviation 0.8273
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgM, 12M FU
|
0.384 Gram per liter
Standard Deviation 0.3463
|
0.487 Gram per liter
Standard Deviation 0.2743
|
0.3334 Gram per liter
Standard Deviation 0.2833
|
0.500 Gram per liter
Standard Deviation 0.5197
|
—
|
0.240 Gram per liter
Standard Deviation 0.0566
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgA, 18M FU
|
0.520 Gram per liter
Standard Deviation 0.2803
|
1.095 Gram per liter
Standard Deviation 0.2616
|
0.500 Gram per liter
Standard Deviation 0.2965
|
0.660 Gram per liter
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
0.300 Gram per liter
Standard Deviation 0.000
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgG, 18M FU
|
4.513 Gram per liter
Standard Deviation 2.0789
|
6.620 Gram per liter
Standard Deviation 2.3759
|
4.206 Gram per liter
Standard Deviation 2.0405
|
6.660 Gram per liter
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
4.265 Gram per liter
Standard Deviation 1.1384
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgA, 24M FU
|
0.540 Gram per liter
Standard Deviation 0.2667
|
1.540 Gram per liter
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
0.480 Gram per liter
Standard Deviation 0.2662
|
0.780 Gram per liter
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgG, 24M FU
|
5.634 Gram per liter
Standard Deviation 2.4734
|
10.900 Gram per liter
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
5.098 Gram per liter
Standard Deviation 2.4977
|
7.780 Gram per liter
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgM, 24M FU
|
0.490 Gram per liter
Standard Deviation 0.3621
|
1.710 Gram per liter
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
0.333 Gram per liter
Standard Deviation 0.0971
|
1.120 Gram per liter
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgM, 30M FU
|
0.400 Gram per liter
Standard Deviation 0.1131
|
0.770 Gram per liter
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
0.400 Gram per liter
Standard Deviation 0.1131
|
—
|
—
|
—
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgA, 36M FU
|
0.550 Gram per liter
Standard Deviation 0.3111
|
1.680 Gram per liter
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
0.550 Gram per liter
Standard Deviation 0.3111
|
—
|
—
|
—
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgG, 42M FU
|
4.425 Gram per liter
Standard Deviation 3.5143
|
11.500 Gram per liter
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
4.425 Gram per liter
Standard Deviation 3.5143
|
—
|
—
|
—
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgG, SCR
|
6.909 Gram per liter
Standard Deviation 4.6836
|
8.615 Gram per liter
Standard Deviation 12.1625
|
6.270 Gram per liter
Standard Deviation 3.8573
|
8.128 Gram per liter
Standard Deviation 4.7569
|
6.898 Gram per liter
Standard Deviation 5.1142
|
—
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgM, SCR
|
0.800 Gram per liter
Standard Deviation 1.3154
|
0.601 Gram per liter
Standard Deviation 0.7061
|
0.800 Gram per liter
Standard Deviation 1.6649
|
0.468 Gram per liter
Standard Deviation 0.3801
|
0.907 Gram per liter
Standard Deviation 1.2822
|
—
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgG, C7W4
|
6.250 Gram per liter
Standard Deviation 3.5225
|
—
|
5.817 Gram per liter
Standard Deviation 3.4944
|
7.254 Gram per liter
Standard Deviation 3.7588
|
5.420 Gram per liter
Standard Deviation 2.2062
|
5.135 Gram per liter
Standard Deviation 2.6309
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgG, C9W4
|
6.164 Gram per liter
Standard Deviation 3.5886
|
—
|
5.553 Gram per liter
Standard Deviation 3.0792
|
7.768 Gram per liter
Standard Deviation 4.5126
|
—
|
5.709 Gram per liter
Standard Deviation 2.1629
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgA, 6M FU
|
—
|
0.880 Gram per liter
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
—
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgG, 6M FU
|
—
|
8.670 Gram per liter
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
—
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgM, 6M FU
|
—
|
0.200 Gram per liter
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
—
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgA, 9M FU
|
0.890 Gram per liter
Standard Deviation 0.0849
|
0.510 Gram per liter
Standard Deviation 0.4585
|
0.890 Gram per liter
Standard Deviation 0.0849
|
—
|
—
|
—
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgG, 9M FU
|
7.695 Gram per liter
Standard Deviation 0.9263
|
5.016 Gram per liter
Standard Deviation 2.4292
|
7.695 Gram per liter
Standard Deviation 0.9263
|
—
|
—
|
—
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgM, 9M FU
|
0.375 Gram per liter
Standard Deviation 0.1061
|
0.246 Gram per liter
Standard Deviation 0.0706
|
0.375 Gram per liter
Standard Deviation 0.1061
|
—
|
—
|
—
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgM, 18M FU
|
0.417 Gram per liter
Standard Deviation 3.3156
|
0.640 Gram per liter
Standard Deviation 0.2687
|
0.317 Gram per liter
Standard Deviation 0.1490
|
1.120 Gram per liter
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
0.240 Gram per liter
Standard Deviation 0.0566
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgA, 30M FU
|
0.505 Gram per liter
Standard Deviation 0.2900
|
1.380 Gram per liter
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
0.505 Gram per liter
Standard Deviation 0.2900
|
—
|
—
|
—
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgG, 30M FU
|
3.460 Gram per liter
Standard Deviation 1.8809
|
11.100 Gram per liter
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
3.460 Gram per liter
Standard Deviation 1.8809
|
—
|
—
|
—
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgG, 36M FU
|
4.320 Gram per liter
Standard Deviation 2.2486
|
13.600 Gram per liter
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
4.320 Gram per liter
Standard Deviation 2.2486
|
—
|
—
|
—
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgM, 36M FU
|
1.175 Gram per liter
Standard Deviation 0.2899
|
0.720 Gram per liter
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
1.175 Gram per liter
Standard Deviation 0.2899
|
—
|
—
|
—
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgA, 42M FU
|
0.545 Gram per liter
Standard Deviation 0.2051
|
1.410 Gram per liter
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
0.545 Gram per liter
Standard Deviation 0.2051
|
—
|
—
|
—
|
|
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
IgM, 42M FU
|
2.155 Gram per liter
Standard Deviation 0.8697
|
0.470 Gram per liter
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
2.155 Gram per liter
Standard Deviation 0.8697
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the randomization date up to 60 months post the randomization date.Population: Safety Population. Only those participants with post-OFA treatment HAHA results were analyzed.
The presence of HAHA in human serum was determined using a validated electrochemiluminescent assay in a multi-tier assay format. All samples were first assessed in a screening (SCR) assay, and the potential positive (Pos) samples were further tested in the confirmation (CNF) assays. Confirmed positives were reported as HAHA positive and titer was determined for each positive sample. The drug tolerance of the HAHA assay is 200 microgram/milliliter (µg/mL); thus, samples that tested negative in the assay and had ofatumumab concentrations no more than 200 µg/mL were considered as conclusive negative (Neg) results.
Outcome measures
| Measure |
Any Ofatumumab (OFA)
n=78 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Physician's Choice (PC)
n=24 Participants
Par. randomized to receive PC trt during Randomization 1 were admin. treatments approved for Chronic Lymphocytic Leukaemia (CLL) \& well-established standards of care as prescribed with standard dose \& route. Experimental therapies or any doses beyond approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for max. trt duration of 48 weeks. Par. entered Follow-up after OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status \& anti-cancer therapy information was collected in the SFU. Par. did not receive OFA salvage trt \& demonstrated PD, entered SFU.Of 43 par 22 went to OFA salvage arm.
|
Ofatumumab Extended (OFA Ext)
n=13 Participants
Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab Observation (OFA Observ.)
n=41 Participants
These participants came from the Physicia's Choice (PC) arm. Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA First Randomization Only (OFA FRO)
n=22 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.
Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA Salvage
The participants in this arm are from the Physician's Choice (PC) arm. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Were Positive or Negative for Human Anti-Human Antibodies (HAHA) Post-OFA Therapy
CNF Pos
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Were Positive or Negative for Human Anti-Human Antibodies (HAHA) Post-OFA Therapy
Neg and no OFA concentration <200 ug/mL
|
12 Participants
|
1 Participants
|
1 Participants
|
10 Participants
|
4 Participants
|
—
|
|
Number of Participants Who Were Positive or Negative for Human Anti-Human Antibodies (HAHA) Post-OFA Therapy
Neg and at least one OFA concentration <200 ug/mL
|
57 Participants
|
23 Participants
|
12 Participants
|
22 Participants
|
15 Participants
|
—
|
SECONDARY outcome
Timeframe: From the randomization date up to 60 months post the randomization date.Population: Intent-to-treat (ITT) population: all participants who were randomised to receive OFA or PC at the first randomisation.
The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL. There are 4 multi-item scales - fatigue (2 items), treatment side effects (\[TSE\], 4 items), disease symptoms (disease effects scale \[DES\], 4 items), and infection (4 items) - and single item scales (social activities \[Social Problems (SP) Scale\] and future health worries\[Future Health (FH) Scale\].). These are measured on a four point scale where 1 = not at all and 4 = very much. These scores are transformed to give a rating from 0 - 100, where 0 =no symptoms or problems and 100 = a severe symptoms or problems. EORTC QLQ-CLL16 was assessed at Screening; Week (W) 12 (W4 of Cycle\[C\] 3), W24 (W4C6), W36 (W4C9), W48 (W4C13); during Follow-up which was every month for Months (M) 1-6, every 8 weeks for M7-12 and every 3 months up to M60; and then at PD.
Outcome measures
| Measure |
Any Ofatumumab (OFA)
n=79 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Physician's Choice (PC)
n=43 Participants
Par. randomized to receive PC trt during Randomization 1 were admin. treatments approved for Chronic Lymphocytic Leukaemia (CLL) \& well-established standards of care as prescribed with standard dose \& route. Experimental therapies or any doses beyond approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for max. trt duration of 48 weeks. Par. entered Follow-up after OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status \& anti-cancer therapy information was collected in the SFU. Par. did not receive OFA salvage trt \& demonstrated PD, entered SFU.Of 43 par 22 went to OFA salvage arm.
|
Ofatumumab Extended (OFA Ext)
n=24 Participants
Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab Observation (OFA Observ.)
n=13 Participants
These participants came from the Physicia's Choice (PC) arm. Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA First Randomization Only (OFA FRO)
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.
Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA Salvage
The participants in this arm are from the Physician's Choice (PC) arm. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
|---|---|---|---|---|---|---|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
DES, C6W4
|
-8.5 unit on a scale
Standard Deviation 15.82
|
-6.4 unit on a scale
Standard Deviation 16.37
|
-8.3 unit on a scale
Standard Deviation 14.95
|
-9.8 unit on a scale
Standard Deviation 18.19
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
DES, C9W4
|
-11 unit on a scale
Standard Deviation 17.72
|
—
|
-7.5 unit on a scale
Standard Deviation 17.91
|
-19.8 unit on a scale
Standard Deviation 14.73
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
DES, 9MFU
|
0 unit on a scale
Standard Deviation 23.57
|
-9.7 unit on a scale
Standard Deviation 9.74
|
0 unit on a scale
Standard Deviation 23.57
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
DES, 15MFU
|
-4.8 unit on a scale
Standard Deviation 13.49
|
-5.6 unit on a scale
Standard Deviation 17.35
|
-4.8 unit on a scale
Standard Deviation 13.49
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
DES, 21MFU
|
5.6 unit on a scale
Standard Deviation 20.97
|
-12.5 unit on a scale
Standard Deviation 5.89
|
5.6 unit on a scale
Standard Deviation 20.97
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
DES, 27MFU
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
DES, 30MFU
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Fatigue Scale, 5MFU
|
—
|
16.7 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Fatigue Scale, 9MFU
|
41.7 unit on a scale
Standard Deviation 82.5
|
-8.3 unit on a scale
Standard Deviation 22.97
|
41.7 unit on a scale
Standard Deviation 82.5
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Fatigue Scale, 11MFU
|
16.7 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
-6.7 unit on a scale
Standard Deviation 19
|
-16.7 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Fatigue Scale,12MFU
|
5 unit on a scale
Standard Deviation 20.86
|
-22.2 unit on a scale
Standard Deviation 9.62
|
6.3 unit on a scale
Standard Deviation 21.71
|
0 unit on a scale
Standard Deviation 23.57
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Fatigue Scale, 30MFU
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Future Health Scale, C6W4
|
-12.9 unit on a scale
Standard Deviation 29.83
|
-5.1 unit on a scale
Standard Deviation 18.49
|
-11.1 unit on a scale
Standard Deviation 25.38
|
-24.2 unit on a scale
Standard Deviation 39.7
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Future Health Scale, C12W4
|
-4.4 unit on a scale
Standard Deviation 39.57
|
—
|
-4.4 unit on a scale
Standard Deviation 39.57
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Future Health Scale, 15MFU
|
19 unit on a scale
Standard Deviation 17.82
|
-11.1 unit on a scale
Standard Deviation 19.25
|
19 unit on a scale
Standard Deviation 17.82
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Future Health Scale, 18MFU
|
20 unit on a scale
Standard Deviation 18.26
|
-16.7 unit on a scale
Standard Deviation 23.57
|
20 unit on a scale
Standard Deviation 18.26
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Future Health Scale, 21MFU
|
22.2 unit on a scale
Standard Deviation 19.25
|
-16.7 unit on a scale
Standard Deviation 23.57
|
22.2 unit on a scale
Standard Deviation 19.25
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Future Health Scale, 24MFU
|
33.3 unit on a scale
Standard Deviation 47.14
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
33.3 unit on a scale
Standard Deviation 47.14
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Future Health Scale, 27MFU
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Future Health Scale, 30MFU
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Infection Scale, C3W4
|
2.1 unit on a scale
Standard Deviation 23.6
|
3.2 unit on a scale
Standard Deviation 19.63
|
-1 unit on a scale
Standard Deviation 20.01
|
-5.6 unit on a scale
Standard Deviation 12.48
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Infection Scale, 18MFU
|
5 unit on a scale
Standard Deviation 12.64
|
-8.3 unit on a scale
Standard Deviation 11.79
|
5 unit on a scale
Standard Deviation 12.64
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
SP Scale, 21MFU
|
-22.2 unit on a scale
Standard Deviation 38.49
|
-16.7 unit on a scale
Standard Deviation 23.57
|
-22.2 unit on a scale
Standard Deviation 38.49
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
SP Scale, 27MFU
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
NA unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
TSE Scale, C12W4
|
-2.8 unit on a scale
Standard Deviation 14.66
|
—
|
-2.8 unit on a scale
Standard Deviation 14.66
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
TSE Scale, 9MFU
|
8.3 unit on a scale
Standard Deviation 11.79
|
-1.4 unit on a scale
Standard Deviation 9.74
|
8.3 unit on a scale
Standard Deviation 11.79
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
TSE Scale, 12MFU
|
-4.2 unit on a scale
Standard Deviation 19.74
|
2.8 unit on a scale
Standard Deviation 12.73
|
0 unit on a scale
Standard Deviation 12.6
|
-20.8 unit on a scale
Standard Deviation 41.25
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
TSE Scale, 15MFU
|
-8.3 unit on a scale
Standard Deviation 12.73
|
2.8 unit on a scale
Standard Deviation 9.62
|
-8.3 unit on a scale
Standard Deviation 12.73
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
TSE Scale, 21MFU
|
8.3 unit on a scale
Standard Deviation 22.05
|
0 unit on a scale
Standard Deviation 0
|
8.3 unit on a scale
Standard Deviation 22.05
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
TSE Scale, 24MFU
|
4.2 unit on a scale
Standard Deviation 5.89
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
4.2 unit on a scale
Standard Deviation 5.89
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Fatigue Scale, 18MFU
|
3.3 unit on a scale
Standard Deviation 21.73
|
0 unit on a scale
Standard Deviation 0
|
3.3 unit on a scale
Standard Deviation 21.73
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Fatigue Scale, 21MFU
|
16.7 unit on a scale
Standard Deviation 28.87
|
0 unit on a scale
Standard Deviation 23.57
|
16.7 unit on a scale
Standard Deviation 28.87
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Fatigue Scale, 24MFU
|
41.7 unit on a scale
Standard Deviation 58.93
|
16.7 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
41.7 unit on a scale
Standard Deviation 58.93
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Fatigue Scale, 27MFU
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Future Health Scale, C3W4
|
-6.9 unit on a scale
Standard Deviation 27.04
|
-7.9 unit on a scale
Standard Deviation 31.46
|
-4.2 unit on a scale
Standard Deviation 22.66
|
-6.1 unit on a scale
Standard Deviation 29.13
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Future Health Scale, C9W4
|
-14.3 unit on a scale
Standard Deviation 27.86
|
—
|
-11.7 unit on a scale
Standard Deviation 27.09
|
-20.8 unit on a scale
Standard Deviation 30.54
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Future Health Scale, 5MFU
|
—
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Future Health Scale, 6MFU
|
—
|
33.3 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Future Health Scale, 7MFU
|
—
|
-12.5 unit on a scale
Standard Deviation 24.8
|
—
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Future Health Scale, 9MFU
|
0 unit on a scale
Standard Deviation 47.14
|
-22.2 unit on a scale
Standard Deviation 40.37
|
0 unit on a scale
Standard Deviation 47.14
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Future Health Scale, 11MFU
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
-13.3 unit on a scale
Standard Deviation 18.26
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Future Health Scale, 12MFU
|
-10 unit on a scale
Standard Deviation 31.62
|
-11.1 unit on a scale
Standard Deviation 19.25
|
-4.2 unit on a scale
Standard Deviation 33.03
|
-33.3 unit on a scale
Standard Deviation 0
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Infection Scale, C6W4
|
-3.7 unit on a scale
Standard Deviation 22.66
|
12.2 unit on a scale
Standard Deviation 25.6
|
-5.6 unit on a scale
Standard Deviation 19.91
|
-6.8 unit on a scale
Standard Deviation 19.3
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Infection Scale,C9W4
|
-7.4 unit on a scale
Standard Deviation 18.61
|
—
|
-7.5 unit on a scale
Standard Deviation 16.86
|
-7.3 unit on a scale
Standard Deviation 23.75
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Infection Scale, C12W4
|
-11.7 unit on a scale
Standard Deviation 14.02
|
—
|
-11.7 unit on a scale
Standard Deviation 14.02
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Infection Scale, 5MFU
|
—
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Infection Scale, 6MFU
|
—
|
8.3 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Infection Scale, 7MFU
|
—
|
-9.4 unit on a scale
Standard Deviation 12.15
|
—
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Infection Scale, 9MFU
|
16.7 unit on a scale
Standard Deviation 23.57
|
0 unit on a scale
Standard Deviation 13.94
|
16.7 unit on a scale
Standard Deviation 23.57
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Infection Scale, 11MFU
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
-6.7 unit on a scale
Standard Deviation 12.36
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Infection Scale, 12MFU
|
-7.5 unit on a scale
Standard Deviation 20.58
|
2.8 unit on a scale
Standard Deviation 12.73
|
-6.2 unit on a scale
Standard Deviation 20.29
|
-12.5 unit on a scale
Standard Deviation 29.46
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Infection Scale, 15MFU
|
-2.4 unit on a scale
Standard Deviation 17.82
|
-2.8 unit on a scale
Standard Deviation 20.97
|
-2.4 unit on a scale
Standard Deviation 17.82
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Infection Scale, 21MFU
|
2.8 unit on a scale
Standard Deviation 12.73
|
8.3 unit on a scale
Standard Deviation 0
|
2.8 unit on a scale
Standard Deviation 12.73
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Infection Scale, 24MFU
|
0 unit on a scale
Standard Deviation 0
|
8.3 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
0 unit on a scale
Standard Deviation 0
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Infection Scale, 27MFU
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Infection Scale, 30MFU
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
SP Scale, C3W4
|
-9 unit on a scale
Standard Deviation 27.56
|
3.2 unit on a scale
Standard Deviation 36.37
|
-11.1 unit on a scale
Standard Deviation 23.4
|
-13.9 unit on a scale
Standard Deviation 30.01
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
SP Scale, C6W4
|
-10.6 unit on a scale
Standard Deviation 27.63
|
10.3 unit on a scale
Standard Deviation 31.58
|
-9.7 unit on a scale
Standard Deviation 25.02
|
-15.2 unit on a scale
Standard Deviation 31.14
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
SP Scale, C9W4
|
-13.1 unit on a scale
Standard Deviation 27.72
|
—
|
-11.7 unit on a scale
Standard Deviation 29.17
|
-16.7 unit on a scale
Standard Deviation 25.2
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
SP Scale, C12W4
|
-11.1 unit on a scale
Standard Deviation 37.09
|
—
|
-11.1 unit on a scale
Standard Deviation 37.09
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
SP Scale, 5MFU
|
—
|
-33.3 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
SP Scale, 6MFU
|
—
|
-66.7 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
SP Scale, 7MFU
|
—
|
-16.7 unit on a scale
Standard Deviation 25.2
|
—
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
SP Scale, 9MFU
|
16.7 unit on a scale
Standard Deviation 70.71
|
-5.6 unit on a scale
Standard Deviation 32.77
|
16.7 unit on a scale
Standard Deviation 70.71
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
SP Scale, 11MFU
|
-33.3 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
-6.7 unit on a scale
Standard Deviation 36.51
|
-33.3 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
SP Scale, 12MFU
|
-16.7 unit on a scale
Standard Deviation 23.57
|
-22.2 unit on a scale
Standard Deviation 19.25
|
-16.7 unit on a scale
Standard Deviation 25.2
|
-16.7 unit on a scale
Standard Deviation 23.57
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
SP Scale, 15MFU
|
-9.5 unit on a scale
Standard Deviation 37.09
|
-11.1 unit on a scale
Standard Deviation 19.25
|
-9.5 unit on a scale
Standard Deviation 37.09
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
SP Scale, 18MFU
|
0 unit on a scale
Standard Deviation 23.57
|
-16.7 unit on a scale
Standard Deviation 23.57
|
0 unit on a scale
Standard Deviation 23.57
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
SP Scale, 24MFU
|
33.3 unit on a scale
Standard Deviation 47.14
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
33.3 unit on a scale
Standard Deviation 47.14
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
SP Scale, 30MFU
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
TSE Scale, C3W4
|
-4.8 unit on a scale
Standard Deviation 15.33
|
-1.5 unit on a scale
Standard Deviation 16.82
|
-2.4 unit on a scale
Standard Deviation 10.85
|
-8.3 unit on a scale
Standard Deviation 13.76
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
TSE Scale, C6W4
|
-4.2 unit on a scale
Standard Deviation 14.33
|
3.2 unit on a scale
Standard Deviation 12.52
|
-0.2 unit on a scale
Standard Deviation 11.32
|
-9.1 unit on a scale
Standard Deviation 16.44
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
TSE Scale, C9W4
|
-5.4 unit on a scale
Standard Deviation 15.75
|
—
|
-3.7 unit on a scale
Standard Deviation 13.91
|
-9.4 unit on a scale
Standard Deviation 20.14
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
TSE Scale, 5MFU
|
—
|
16.7 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
TSE Scale, 6MFU
|
—
|
16.7 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
TSE Scale, 7MFU
|
—
|
-8.3 unit on a scale
Standard Deviation 17.82
|
—
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
TSE Scale, 11MFU
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
-1.7 unit on a scale
Standard Deviation 14.91
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
TSE Scale, 18MFU
|
6.7 unit on a scale
Standard Deviation 16.03
|
0 unit on a scale
Standard Deviation 11.79
|
6.7 unit on a scale
Standard Deviation 16.03
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
TSE Scale, 27MFU
|
8.3 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
8.3 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
TSE Scale, 30MFU
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
DES, C3W4
|
-10.3 unit on a scale
Standard Deviation 17.60
|
-6.3 unit on a scale
Standard Deviation 16.22
|
-9.7 unit on a scale
Standard Deviation 12.20
|
-10.4 unit on a scale
Standard Deviation 17.09
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
DES, C12W4
|
-3.3 unit on a scale
Standard Deviation 21.78
|
—
|
-3.3 unit on a scale
Standard Deviation 21.78
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
DES, 5MFU
|
—
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
DES, 6MFU
|
—
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
DES, 7MFU
|
—
|
-14.6 unit on a scale
Standard Deviation 16.52
|
—
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
DES, 11MFU
|
-25 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
-6.7 unit on a scale
Standard Deviation 18.07
|
-25 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
DES, 12MFU
|
-10.8 unit on a scale
Standard Deviation 14.19
|
-2.8 unit on a scale
Standard Deviation 20.97
|
-10.4 unit on a scale
Standard Deviation 14.6
|
-12.5 unit on a scale
Standard Deviation 17.68
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
DES, 18MFU
|
-3.3 unit on a scale
Standard Deviation 13.94
|
-20.8 unit on a scale
Standard Deviation 17.68
|
-3.3 unit on a scale
Standard Deviation 13.94
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
DES, 24MFU
|
4.2 unit on a scale
Standard Deviation 5.89
|
0 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
4.2 unit on a scale
Standard Deviation 5.89
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Fatigue Scale, C3W4
|
-4 unit on a scale
Standard Deviation 24.04
|
2.4 unit on a scale
Standard Deviation 21.91
|
-2.1 unit on a scale
Standard Deviation 19.23
|
-12.5 unit on a scale
Standard Deviation 24.75
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Fatigue Scale, C6W4
|
-5.7 unit on a scale
Standard Deviation 19.99
|
12.8 unit on a scale
Standard Deviation 29.78
|
-0.7 unit on a scale
Standard Deviation 16.65
|
-13.6 unit on a scale
Standard Deviation 19.46
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Fatigue Scale, C9W4
|
-4.2 unit on a scale
Standard Deviation 25.1
|
—
|
0 unit on a scale
Standard Deviation 24.78
|
-14.6 unit on a scale
Standard Deviation 24.3
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Fatigue Scale, C12W4
|
7.8 unit on a scale
Standard Deviation 33.85
|
—
|
7.8 unit on a scale
Standard Deviation 33.85
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Fatigue Scale, 6MFU
|
—
|
16.7 unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Fatigue Scale, 7MFU
|
—
|
-14.6 unit on a scale
Standard Deviation 18.77
|
—
|
—
|
—
|
—
|
|
Changes From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)
Fatigue Scale, 15MFU
|
2.4 unit on a scale
Standard Deviation 22.42
|
0 unit on a scale
Standard Deviation 16.67
|
2.4 unit on a scale
Standard Deviation 22.42
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the randomization date up to 60 months post the randomization date.Population: Population Description: Intent-to-treat (ITT) population: all participants who were randomised to receive OFA or PC at the first randomisation.
The HCQ consists of a single question in which the participant is asked if he/she has experienced any change in his/her health overall since beginning the study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for 'my health is a great deal better' to 9 for 'my health is a great deal worse' since the beginning of the study. A score of 3 or less indicates improvement from Baseline. HCQ was assessed at Screening; Week (W) 12 (W4 of Cycle\[C\] 3), W24 (W4C6), W36 (W4C9), W48 (W4C13); during follow-up which was every month for Months 1-6, every 8 weeks for M7-12 and every 3 months up to M60; and then at PD..
Outcome measures
| Measure |
Any Ofatumumab (OFA)
n=79 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Physician's Choice (PC)
n=43 Participants
Par. randomized to receive PC trt during Randomization 1 were admin. treatments approved for Chronic Lymphocytic Leukaemia (CLL) \& well-established standards of care as prescribed with standard dose \& route. Experimental therapies or any doses beyond approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for max. trt duration of 48 weeks. Par. entered Follow-up after OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status \& anti-cancer therapy information was collected in the SFU. Par. did not receive OFA salvage trt \& demonstrated PD, entered SFU.Of 43 par 22 went to OFA salvage arm.
|
Ofatumumab Extended (OFA Ext)
n=24 Participants
Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab Observation (OFA Observ.)
n=13 Participants
These participants came from the Physicia's Choice (PC) arm. Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA First Randomization Only (OFA FRO)
n=42 Participants
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization.
Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
OFA Salvage
n=22 Participants
The participants in this arm are from the Physician's Choice (PC) arm. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
|---|---|---|---|---|---|---|
|
Mean Health Change Questionnaire (HCQ) Score
C3W4
|
2.8 Unit on a scale
Standard Deviation 1.57
|
3.9 Unit on a scale
Standard Deviation 2.01
|
2.5 Unit on a scale
Standard Deviation 1.44
|
2.8 Unit on a scale
Standard Deviation 0.97
|
3.2 Unit on a scale
Standard Deviation 1.90
|
3.1 Unit on a scale
Standard Deviation 1.92
|
|
Mean Health Change Questionnaire (HCQ) Score
C6W4
|
3.2 Unit on a scale
Standard Deviation 2.04
|
3.5 Unit on a scale
Standard Deviation 2.37
|
2.7 Unit on a scale
Standard Deviation 1.66
|
2.9 Unit on a scale
Standard Deviation 1.76
|
5.1 Unit on a scale
Standard Deviation 2.37
|
3.0 Unit on a scale
Standard Deviation 2.00
|
|
Mean Health Change Questionnaire (HCQ) Score
C9W4
|
2.8 Unit on a scale
Standard Deviation 1.60
|
—
|
2.5 Unit on a scale
Standard Deviation 1.36
|
3.5 Unit on a scale
Standard Deviation 2.00
|
—
|
3.1 Unit on a scale
Standard Deviation 2.48
|
|
Mean Health Change Questionnaire (HCQ) Score
5MFU
|
—
|
5.0 Unit on a scale
Standard Deviation NA
No participants were analyzed for this category at this time point therefore there is no data to present. There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
—
|
|
Mean Health Change Questionnaire (HCQ) Score
6MFU
|
—
|
3.0 Unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
—
|
|
Mean Health Change Questionnaire (HCQ) Score
18MFU
|
2.6 Unit on a scale
Standard Deviation 2.15
|
4.5 Unit on a scale
Standard Deviation 0.71
|
2.8 Unit on a scale
Standard Deviation 2.23
|
1.0 Unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
4.0 Unit on a scale
Standard Deviation 4.24
|
|
Mean Health Change Questionnaire (HCQ) Score
36MFU
|
3.0 Unit on a scale
Standard Deviation 2.83
|
5.0 Unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
3.0 Unit on a scale
Standard Deviation 2.83
|
—
|
—
|
—
|
|
Mean Health Change Questionnaire (HCQ) Score
45MFU
|
1.0 Unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
7.0 Unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
1.0 Unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
|
Mean Health Change Questionnaire (HCQ) Score
C12W4
|
2.6 Unit on a scale
Standard Deviation 1.99
|
—
|
2.6 Unit on a scale
Standard Deviation 1.99
|
—
|
—
|
3.0 Unit on a scale
Standard Deviation 1.83
|
|
Mean Health Change Questionnaire (HCQ) Score
3MFU
|
—
|
—
|
—
|
—
|
—
|
3.0 Unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
|
Mean Health Change Questionnaire (HCQ) Score
7MFU
|
—
|
2.4 Unit on a scale
Standard Deviation 1.30
|
—
|
—
|
—
|
—
|
|
Mean Health Change Questionnaire (HCQ) Score
9MFU
|
6.5 Unit on a scale
Standard Deviation 2.12
|
3.5 Unit on a scale
Standard Deviation 2.07
|
6.5 Unit on a scale
Standard Deviation 2.12
|
—
|
—
|
—
|
|
Mean Health Change Questionnaire (HCQ) Score
11MFU
|
5.0 Unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
3.0 Unit on a scale
Standard Deviation 2.35
|
5.0 Unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
|
Mean Health Change Questionnaire (HCQ) Score
12MFU
|
3.4 Unit on a scale
Standard Deviation 2.07
|
2.3 Unit on a scale
Standard Deviation 1.53
|
3.5 Unit on a scale
Standard Deviation 2.27
|
3.0 Unit on a scale
Standard Deviation 1.41
|
—
|
2.0 Unit on a scale
Standard Deviation 1.41
|
|
Mean Health Change Questionnaire (HCQ) Score
15MFU
|
3.5 Unit on a scale
Standard Deviation 2.27
|
3.7 Unit on a scale
Standard Deviation 1.53
|
3.7 Unit on a scale
Standard Deviation 2.35
|
2.0 Unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
2.0 Unit on a scale
Standard Deviation 1.00
|
|
Mean Health Change Questionnaire (HCQ) Score
21MFU
|
2.0 Unit on a scale
Standard Deviation 1.22
|
6.0 Unit on a scale
Standard Deviation 1.41
|
2.3 Unit on a scale
Standard Deviation 1.26
|
1.0 Unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
|
Mean Health Change Questionnaire (HCQ) Score
24MFU
|
2.5 Unit on a scale
Standard Deviation 3.00
|
4.0 Unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
3.0 Unit on a scale
Standard Deviation 3.46
|
1.0 Unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
|
Mean Health Change Questionnaire (HCQ) Score
27MFU
|
2.7 Unit on a scale
Standard Deviation 2.89
|
5.0 Unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
3.5 Unit on a scale
Standard Deviation 3.54
|
1.0 Unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
|
Mean Health Change Questionnaire (HCQ) Score
30MFU
|
1.0 Unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
5.0 Unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
1.0 Unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
—
|
—
|
—
|
|
Mean Health Change Questionnaire (HCQ) Score
33MFU
|
3.0 Unit on a scale
Standard Deviation 2.83
|
5.0 Unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
3.0 Unit on a scale
Standard Deviation 2.83
|
—
|
—
|
—
|
|
Mean Health Change Questionnaire (HCQ) Score
39MFU
|
4.0 Unit on a scale
Standard Deviation 4.24
|
7.0 Unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
4.0 Unit on a scale
Standard Deviation 4.24
|
—
|
—
|
—
|
|
Mean Health Change Questionnaire (HCQ) Score
42MFU
|
3.0 Unit on a scale
Standard Deviation 2.83
|
5.0 Unit on a scale
Standard Deviation NA
There were too few participants analyzed at this time point to calculate a standard deviation.
|
3.0 Unit on a scale
Standard Deviation 2.83
|
—
|
—
|
—
|
Adverse Events
Any Ofatumumab
Serious events: 43 serious events
Other events: 63 other events
Deaths: 16 deaths
Ofatumumab Extended
Serious events: 12 serious events
Other events: 20 other events
Deaths: 2 deaths
Ofatumumab Observation
Serious events: 5 serious events
Other events: 10 other events
Deaths: 3 deaths
Ofatumumab
Serious events: 26 serious events
Other events: 33 other events
Deaths: 11 deaths
Physicians Choice
Serious events: 23 serious events
Other events: 30 other events
Deaths: 8 deaths
Ofatumumab Salvage
Serious events: 10 serious events
Other events: 13 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Any Ofatumumab
n=78 participants at risk
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab Extended
n=24 participants at risk
Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab Observation
n=13 participants at risk
Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab
n=41 participants at risk
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization. Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Physicians Choice
n=43 participants at risk
Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive s(ingleagent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU
|
Ofatumumab Salvage
n=22 participants at risk
Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anticancer therapy information was collected in the SFU.
|
|---|---|---|---|---|---|---|
|
Vascular disorders
Thrombophlebitis
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Blood and lymphatic system disorders
Anaemia
|
2.6%
2/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
9.3%
4/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
9.1%
2/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.7%
2/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.0%
7/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
14.6%
6/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
9.3%
4/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
2/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.9%
2/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Cardiac disorders
Cardiac arrest
|
2.6%
2/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.9%
2/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Cardiac disorders
Cardiac failure
|
2.6%
2/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
9.1%
2/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Cardiac disorders
Cardiovascular insufficiency
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Cardiac disorders
Myocardial infarction
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Cardiac disorders
Ventricular tachycardia
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Eye disorders
Chorioretinal atrophy
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
General disorders
Chills
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
General disorders
Death
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
General disorders
General physical health deterioration
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
General disorders
Oedema peripheral
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
General disorders
Pyrexia
|
5.1%
4/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
9.8%
4/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.0%
3/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
9.1%
2/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Hepatobiliary disorders
Hepatotoxicity
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Abscess neck
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Acute sinusitis
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Bronchitis
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Cellulitis
|
2.6%
2/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Device related infection
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Empyema
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Enterocolitis infectious
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Gastrointestinal fungal infection
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Hepatitis B
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Hepatitis E
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Lower respiratory tract infection
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Lung infection
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Meningitis
|
2.6%
2/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Meningitis aseptic
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Neutropenic sepsis
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.7%
2/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Otosalpingitis
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Pneumonia
|
12.8%
10/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
12.5%
3/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
14.6%
6/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
16.3%
7/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
13.6%
3/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Progressive multifocal leukoencephalopathy
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Pseudomembranous colitis
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Sepsis
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
9.3%
4/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
9.1%
2/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Skin infection
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
3/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Urinary tract infection
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Viral infection
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Viral tonsillitis
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Investigations
Blood pressure decreased
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Investigations
C-reactive protein increased
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large cell lung cancer
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Nervous system disorders
Chorea
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Nervous system disorders
Seizure
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Renal and urinary disorders
Hydronephrosis
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Renal and urinary disorders
Renal failure
|
2.6%
2/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.9%
2/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Renal and urinary disorders
Renal impairment
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.6%
2/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Vascular disorders
Hypotension
|
2.6%
2/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.9%
2/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
Other adverse events
| Measure |
Any Ofatumumab
n=78 participants at risk
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab Extended
n=24 participants at risk
Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab Observation
n=13 participants at risk
Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Ofatumumab
n=41 participants at risk
Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. These participants were only randomized once and did not get make it to the second randomization. Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
|
Physicians Choice
n=43 participants at risk
Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive s(ingleagent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU
|
Ofatumumab Salvage
n=22 participants at risk
Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anticancer therapy information was collected in the SFU.
|
|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
2.6%
2/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Eye disorders
Visual impairment
|
2.6%
2/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.1%
4/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
8.3%
2/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.9%
2/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Blood and lymphatic system disorders
Anaemia
|
6.4%
5/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
8.3%
2/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.3%
3/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
11.6%
5/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.6%
2/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Blood and lymphatic system disorders
Neutropenia
|
19.2%
15/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
41.7%
10/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
9.8%
4/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
18.6%
8/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
13.6%
3/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.3%
8/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
12.5%
3/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
9.8%
4/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.0%
3/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Cardiac disorders
Cardiac failure
|
3.8%
3/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
8.3%
2/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Ear and labyrinth disorders
Ear congestion
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Ear and labyrinth disorders
Hypoacusis
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Gastrointestinal disorders
Constipation
|
3.8%
3/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Gastrointestinal disorders
Diarrhoea
|
6.4%
5/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
12.2%
5/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
9.3%
4/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
9.1%
2/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Gastrointestinal disorders
Nausea
|
10.3%
8/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
8.3%
2/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
12.2%
5/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
11.6%
5/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
4/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
9.8%
4/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.0%
3/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
General disorders
Asthenia
|
3.8%
3/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.3%
3/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
General disorders
Chills
|
11.5%
9/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
15.4%
2/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
14.6%
6/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
General disorders
Fatigue
|
3.8%
3/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.9%
2/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
9.3%
4/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
General disorders
Oedema peripheral
|
2.6%
2/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.0%
3/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
General disorders
Peripheral swelling
|
5.1%
4/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.3%
3/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
General disorders
Pyrexia
|
10.3%
8/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
8.3%
2/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
12.2%
5/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.0%
3/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
9.1%
2/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Bronchitis
|
9.0%
7/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
20.8%
5/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.9%
2/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.0%
3/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
9.3%
4/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Eye infection
|
2.6%
2/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Fungal infection
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Gastroenteritis
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Herpes virus infection
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Laryngitis
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
5/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
12.5%
3/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Pneumonia
|
5.1%
4/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
12.5%
3/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Respiratory tract infection
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Sialoadenitis
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Sinusitis
|
5.1%
4/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
8.3%
2/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.7%
2/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Tracheitis
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Upper respiratory tract infection
|
5.1%
4/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
15.4%
2/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.9%
2/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
11.6%
5/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
9.1%
2/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Infections and infestations
Urinary tract infection
|
3.8%
3/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.3%
3/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Injury, poisoning and procedural complications
Contusion
|
3.8%
3/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
8.3%
2/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Investigations
Alanine aminotransferase increased
|
5.1%
4/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.9%
2/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Investigations
Aspartate aminotransferase increased
|
3.8%
3/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Investigations
Blood bilirubin increased
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Investigations
Haemoglobin decreased
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Investigations
Lymphocyte count decreased
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Investigations
Neutrophil count decreased
|
2.6%
2/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Investigations
Weight decreased
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.7%
2/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
9.1%
2/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Investigations
Weight increased
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.8%
3/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.3%
3/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
9.1%
2/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.1%
4/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.3%
3/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.6%
2/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
8.3%
2/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.7%
2/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
2/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
15.4%
2/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
4/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.3%
3/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Nervous system disorders
Dizziness
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
9.1%
2/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Nervous system disorders
Headache
|
3.8%
3/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.3%
3/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Nervous system disorders
Hypoaesthesia
|
2.6%
2/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Nervous system disorders
Muscle spasticity
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Nervous system disorders
Paraesthesia
|
3.8%
3/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.9%
2/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Psychiatric disorders
Depressed mood
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.1%
11/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
12.5%
3/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
15.4%
2/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
14.6%
6/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
9.1%
2/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
3/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.7%
2/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.1%
4/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
15.4%
2/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.9%
2/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.5%
1/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.8%
3/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.4%
5/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
12.2%
5/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.7%
2/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.8%
3/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.2%
1/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.4%
1/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.7%
2/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
9.1%
2/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.3%
1/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.8%
3/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
8.3%
2/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
2.3%
1/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Vascular disorders
Flushing
|
3.8%
3/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.7%
1/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
4.9%
2/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
|
Vascular disorders
Hypertension
|
6.4%
5/78 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
8.3%
2/24 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/13 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
7.3%
3/41 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/43 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
0.00%
0/22 • SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER