Ofatumumab vs Physician's Choice in Subjects With Bulky F... | NCT01313689 | Trialant
NCT01313689
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Nov 8, 2018Actual
Enrollment
122Actual
Phase
Phase 3
Conditions
Leukaemia
Interventions
Ofatumumab
Physicians' Choice
Countries
Austria
Belgium
Bulgaria
Czechia
France
Germany
Hungary
Ireland
Israel
Italy
Poland
Russia
Singapore
Slovakia
Sweden
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01313689
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
114242
Secondary IDs
Not provided
Brief Title
Ofatumumab vs Physician's Choice in Subjects With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukemia
Official Title
An Open Label, Multicenter Study Investigating the Safety and Efficacy of Ofatumumab Therapy Versus Physicians' Choice in Patients With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukaemia (CLL)
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Oct 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 14, 2011Actual
Primary Completion Date
Mar 18, 2014Actual
Completion Date
Apr 24, 2017Actual
First Submitted Date
Mar 10, 2011
First Submission Date that Met QC Criteria
Mar 11, 2011
First Posted Date
Mar 14, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 6, 2014
Results First Submitted that Met QC Criteria
Nov 17, 2014
Results First Posted Date
Nov 24, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 9, 2018
Last Update Posted Date
Nov 8, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study was to confirm the clinical benefit observed in the pivotal registration study, Hx-CD20-406. The Committee for Medicinal Products for Human Use (CHMP) required that a randomized study be conducted in CLL patients with bulky fludarabine-refractory disease as a specific obligation for grant of conditional approval for ARZERRA™ in the European Union (EU). This study compared ofatumumab with the physicians' choice of therapy.
Detailed Description
Patients with CLL that is refractory to fludarabine have few treatment options and a poor prognosis. There is a continued need for new therapies for these CLL patients, as demonstrated by the limited responses and substantial toxicities with existing therapies. This is supported by the lack of a consensus around standard of care treatment for CLL patients with bulky fludarabine-refractory disease. The objective of this study was to confirm the response rate and disease control in the refractory setting through a controlled trial comparing ofatumumab with the physicians' choice of therapy in fludarabine-refractory, bulky lymphadenopathy patients. After 24 weeks of treatment with ofatumumab, patients were further randomized to either extended ofatumumab treatment or observation. Patients on the physicians' choice arm had the option of receiving ofatumumab if they experience progressive disease.
Ofatumumab IV, initial dose 300 mg, followed 1 week later with 2000 mg once weekly for 7 weeks, followed 4 weeks later by one infusion of 2000 mg every 4 weeks for 4 infusions, for a total of 12 infusions over 24 weeks. After 24 weeks of ofatumumab treatment, patients who have achieved at least stable disease or better, and whom the investigator would deem appropriate for the therapy to continue, would undergo a second randomisation (2:1) to either 1) an additional ofatumumab dose regimen of 2000 mg once every 4 weeks for up to an additional 24 weeks, or 2) no further therapy (i.e. observation only).
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC)
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.
From the randomization date up to 60 months post the randomization date.
Secondary Outcomes
Measure
Description
Time Frame
Progression-free Survival (PFS) as Assessed by Investigator
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Adults with documented diagnosis of active CLL requiring treatment
Bulky lymphadenopathy, defined as at least 1 lymph node >5 cm
Must be refractory to fludarabine treatment
Age 18 yrs or older
At least 2 prior therapies for CLL
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Signed written informed consent
Exclusion Criteria:
Prior allogeneic stem cell transplant at any time, or autologous stem cell transplant within 6 months
Treatment with any unapproved drug substance or experimental therapy within 4 weeks, or currently participating in another interventional clinical study
CLL transformation, prolymphocytic leukemia, or central nervous system (CNS) involvement of CLL
Active autoimmune hemolytic anemia (AIHA) requiring treatment except if associated with progressive disease requiring anti-CLL treatment
Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
Human immunodeficiency virus (HIV) positive
Significant concurrent, uncontrolled medical condition
Other past or current malignancy (with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix or breast) unless the tumor was successfully treated with curative intent at least 2 years prior to trial entry
Non-protocol corticosteroid usage except a maintenance dose corresponding to less than or equal to 10 mg prednisone
Abnormal lab values: Creatinine > 2.0 times upper normal limit (unless normal creatinine clearance), or total bilirubin > 2.0 times upper normal limit (unless due to liver involvement of CLL or due to Gilbert's syndrome), or alanine transaminase (ALT) > 2.5 times upper normal limit (unless due to liver involvement of CLL)
Known or suspected hypersensitivity to ofatumumab
Lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception
Osterborg A, Udvardy M, Zaritskey A, Andersson PO, Grosicki S, Mazur G, Kaplan P, Steurer M, Schuh A, Montillo M, Kryachok I, Middeke JM, Kulyaba Y, Rekhtman G, Gorczyca M, Daly S, Chang CN, Lisby S, Gupta I. Phase III, randomized study of ofatumumab versus physicians' choice of therapy and standard versus extended-length ofatumumab in patients with bulky fludarabine-refractory chronic lymphocytic leukemia. Leuk Lymphoma. 2016 Sep;57(9):2037-46. doi: 10.3109/10428194.2015.1122783. Epub 2016 Jan 19.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Undecided
Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
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.
Recruitment Details
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
Periods
Title
Milestones
Reasons Not Completed
24-Week Randomization 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Ofatumumab
Physicians' Choice
Drug
Non-ofatumumab containing regimen as per physicians' choice for up to 6 months. Permitted therapies include treatments approved for CLL, and well established standards of care for CLL.
Physicians' Choice
From the randomization date up to 60 months post the randomization date.
Overall Response Rate (ORR) as Assessed by the IRC
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.
From the randomization date up to 60 months post the randomization date.
Overall Response Rate (ORR) as Assessed by the Investigator
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.
From the randomization date up to 60 months post the randomization date.
Overall Survival
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.
From the randomization date up to 60 months post the randomization date.
Time to Progression as Assessed by IRC
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.
From the randomization date up to 60 months post the randomization date.
Time to Next Anti-cancer Therapy by Investigator
Time to next therapy is defined as the time from randomization until the start of the next line of treatment.
From the randomization date up to 60 months post the randomization date.
Time to Response as Assessed by the IRC
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.
From the randomization date up to 60 months post the randomization date.
Duration of Response as Assessed by the IRC
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.
From the randomization date up to 60 months post the randomization date.
Number of Participants With Any Adverse Event (AE), Any Serious Adverse Event (SAE), Any Fatal Serious Adverse Event (FSAE), or Deaths
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.
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 therapy
Number of Participants With Any Adverse Event (AE) of Special Interest
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.
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 therapy
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
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.
Screening and every 3 months during treatment, every 6 months after last treatment until PD or until 42 Month Follow-up Visit
Number of Participants Who Were Positive or Negative for Human Anti-Human Antibodies (HAHA) Post-OFA Therapy
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.
From the randomization date up to 60 months post the randomization date.
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)
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.
From the randomization date up to 60 months post the randomization date.
Mean Health Change Questionnaire (HCQ) Score
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..
From the randomization date up to 60 months post the randomization date.
Innsbruck
6020
Austria
Novartis Investigative Site
Linz
4020
Austria
Novartis Investigative Site
Salzburg
A-5020
Austria
Novartis Investigative Site
Vienna
1140
Austria
Novartis Investigative Site
Brussels
1200
Belgium
Novartis Investigative Site
Leuven
3000
Belgium
Novartis Investigative Site
Sofia
1233
Bulgaria
Novartis Investigative Site
Sofia
1407
Bulgaria
Novartis Investigative Site
Sofia
1431
Bulgaria
Novartis Investigative Site
Hradec Králové
Czechia
Novartis Investigative Site
Olomouc
775 20
Czechia
Novartis Investigative Site
Prague
128 08
Czechia
Novartis Investigative Site
Bobigny
93009
France
Novartis Investigative Site
Brest
29609
France
Novartis Investigative Site
Clermont-Ferrand
63003
France
Novartis Investigative Site
Créteil
94010
France
Novartis Investigative Site
Lille
59037
France
Novartis Investigative Site
Rennes
35033
France
Novartis Investigative Site
Toulouse
31059
France
Novartis Investigative Site
Tours
37044
France
Novartis Investigative Site
Kronach
Bavaria
96317
Germany
Novartis Investigative Site
Regensburg
Bavaria
93053
Germany
Novartis Investigative Site
Frankfurt (Oder)
Brandenburg
15236
Germany
Novartis Investigative Site
Frankfurt am Main
Hesse
60590
Germany
Novartis Investigative Site
Cologne
North Rhine-Westphalia
50937
Germany
Novartis Investigative Site
Essen
North Rhine-Westphalia
45122
Germany
Novartis Investigative Site
Koblenz
Rhineland-Palatinate
56068
Germany
Novartis Investigative Site
Chemnitz
Saxony
09113
Germany
Novartis Investigative Site
Dresden
Saxony
01307
Germany
Novartis Investigative Site
Magdeburg
Saxony-Anhalt
39130
Germany
Novartis Investigative Site
Budapest
1097
Hungary
Novartis Investigative Site
Debrecen
4012
Hungary
Novartis Investigative Site
Pécs
7624
Hungary
Novartis Investigative Site
Szombathely
9700
Hungary
Novartis Investigative Site
Dublin
7
Ireland
Novartis Investigative Site
Galway
Ireland
Novartis Investigative Site
James Street
8
Ireland
Novartis Investigative Site
Jerusalem
91120
Israel
Novartis Investigative Site
Ramat Gan
52621
Israel
Novartis Investigative Site
Modena
Emilia-Romagna
41124
Italy
Novartis Investigative Site
Brescia
Lombardy
25123
Italy
Novartis Investigative Site
Milan
Lombardy
20132
Italy
Novartis Investigative Site
Milan
Lombardy
20162
Italy
Novartis Investigative Site
Turin
Piedmont
10126
Italy
Novartis Investigative Site
Messina
Sicily
95158
Italy
Novartis Investigative Site
Chorzów
41-500
Poland
Novartis Investigative Site
Lodz
93-510
Poland
Novartis Investigative Site
Wroclaw
50-367
Poland
Novartis Investigative Site
Chelyabinsk
454076
Russia
Novartis Investigative Site
Moscow
115478
Russia
Novartis Investigative Site
Saint Petersburg
198205
Russia
Novartis Investigative Site
St'Petersburg
197341
Russia
Novartis Investigative Site
Singapore
169608
Singapore
Novartis Investigative Site
Bratislava
833 10
Slovakia
Novartis Investigative Site
Bratislava
851 07
Slovakia
Novartis Investigative Site
Košice
041 66
Slovakia
Novartis Investigative Site
Martin
036 59
Slovakia
Novartis Investigative Site
Gothenburg
SE-413 45
Sweden
Novartis Investigative Site
Linköping
SE-581 85
Sweden
Novartis Investigative Site
Luleå
SE-971 80
Sweden
Novartis Investigative Site
Örebro
SE-701 85
Sweden
Novartis Investigative Site
Stockholm
SE-171 76
Sweden
Novartis Investigative Site
Umeå
SE-901 85
Sweden
Novartis Investigative Site
Uppsala
SE-751 85
Sweden
Novartis Investigative Site
Cherkasy
18009
Ukraine
Novartis Investigative Site
Dnipropetrovsk
49102
Ukraine
Novartis Investigative Site
Donetsk
83045
Ukraine
Novartis Investigative Site
Kharkiv
61070
Ukraine
Novartis Investigative Site
Khmelnytskyi
29000
Ukraine
Novartis Investigative Site
Kyiv
03022
Ukraine
Novartis Investigative Site
Kyiv
04112
Ukraine
Novartis Investigative Site
Lviv
79044
Ukraine
Novartis Investigative Site
Makiivka
86132
Ukraine
Novartis Investigative Site
Simferopil
95023
Ukraine
Novartis Investigative Site
Vinnitsa
21018
Ukraine
Novartis Investigative Site
Zhytomyr
10002
Ukraine
Novartis Investigative Site
Bournemouth
BH7 7DW
United Kingdom
Novartis Investigative Site
Manchester
M20 4BX
United Kingdom
Novartis Investigative Site
Oxford
OX3 7LE
United Kingdom
FG001
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.
FG002
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.
FG003
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.
FG004
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.
FG00079 subjects
FG00143 subjectsOf the 43 participants in the PC arm, 22 entered the OFA Salvage arm.
FG0020 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG00060 subjectsPar. not entering Randomization 2 continued visits for Follow-up and overall survival assessment
FG00133 subjectsPar. that did not receive OFA salvage continued visits for Follow-up and overall survival assessment
FG0020 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG00019 subjects
FG00110 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Type
Comment
Reasons
Adverse Event
FG00010 subjects
FG0015 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Physician Decision
FG0004 subjects
FG0015 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0005 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
24-Week Randomization 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG00224 subjectsNot all participants from Randomization 1 continued to Randomization 2.
FG00313 subjectsNot all participants from Randomization 1 continued to Randomization 2.
FG00442 subjectsOFA Participants who did not enter Randomization 2.
COMPLETED
FG0000 subjects
FG0010 subjects
FG00221 subjects
FG00312 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG003
The Intent-to-Treat (ITT) population included subjects who were randomized. Note: The Total participants in the Baseline Characteristics Table & 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
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Any Ofatumumab (OFA)
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.
BG001
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.
BG002
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.
BG003
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.
BG004
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.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00079
BG00143
BG00224
BG00313
BG00442
BG005201
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
The Intent-to-Treat (ITT) population included subjects who were randomized.
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00063.3± 8.95
BG00161.8± 9.87
BG00261.7± 9.09
BG003
Sex: Female, Male
The Intent-to-Treat (ITT) population included subjects who were randomized.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00024
BG00114
BG002
Race/Ethnicity, Customized
The Intent-to-Treat (ITT) population included subjects who were randomized.
Number
Participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0001
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC)
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.
Intent-to-treat (ITT) population: all participants who were randomised to receive OFA or PC at the first randomisation.
Posted
Median
95% Confidence Interval
Months
From the randomization date up to 60 months post the randomization date.
ID
Title
Description
OG000
Any Ofatumumab (OFA)
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.
OG001
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.
OG002
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.
Units
Counts
Participants
OG00079
OG00143
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG0005.36(4.30 to 6.97)
OG0013.61(1.87 to 6.74)
OG00210.05(7.23 to 13.80)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum
0.2677
Hazard Ratio (HR)
0.79
2-Sided
95
0.50
1.24
Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum
Superiority or Other
OG002
Secondary
Progression-free Survival (PFS) as Assessed by Investigator
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.
Intent-to-treat (ITT) population: all participants who were randomised to receive OFA or PC at the first randomisation.
Posted
Median
95% Confidence Interval
Months
From the randomization date up to 60 months post the randomization date.
ID
Title
Description
OG000
Any Ofatumumab (OFA)
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.
Secondary
Overall Response Rate (ORR) as Assessed by the IRC
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.
ITT Population. Not evaluable is defined as insufficient data present to classify into one of the other categories.
Posted
Number
Participants
From the randomization date up to 60 months post the randomization date.
ID
Title
Description
OG000
Any Ofatumumab (OFA)
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.
Secondary
Overall Response Rate (ORR) as Assessed by the Investigator
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.
ITT Population. Not evaluable is defined as insufficient data present to classify into one of the other categories.
Posted
Number
Participants
From the randomization date up to 60 months post the randomization date.
ID
Title
Description
OG000
Any Ofatumumab (OFA)
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.
Secondary
Overall Survival
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.
ITT population. Only those participants with data available were analyzed, participants who had not died were censored at the date of last contact.
Posted
Median
95% Confidence Interval
Months
From the randomization date up to 60 months post the randomization date.
ID
Title
Description
OG000
Any Ofatumumab (OFA)
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.
OG001
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.
Secondary
Time to Progression as Assessed by IRC
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.
ITT population. Only those participants with data available were analyzed.
Posted
Median
95% Confidence Interval
Months
From the randomization date up to 60 months post the randomization date.
ID
Title
Description
OG000
Any Ofatumumab (OFA)
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.
Secondary
Time to Next Anti-cancer Therapy by Investigator
Time to next therapy is defined as the time from randomization until the start of the next line of treatment.
ITT population. Only those participants with data available were analyzed.
Posted
Median
95% Confidence Interval
Months
From the randomization date up to 60 months post the randomization date.
ID
Title
Description
OG000
Any Ofatumumab (OFA)
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.
OG001
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.
Secondary
Time to Response as Assessed by the IRC
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.
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.
Posted
Median
95% Confidence Interval
Months
From the randomization date up to 60 months post the randomization date.
ID
Title
Description
OG000
Any Ofatumumab (OFA)
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.
Secondary
Duration of Response as Assessed by the IRC
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.
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.
Posted
Median
95% Confidence Interval
Months
From the randomization date up to 60 months post the randomization date.
ID
Title
Description
OG000
Any Ofatumumab (OFA)
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.
Secondary
Number of Participants With Any Adverse Event (AE), Any Serious Adverse Event (SAE), Any Fatal Serious Adverse Event (FSAE), or Deaths
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.
Safety Population: all participants who received at least one dose of any study treatment (OFA or PC) at the first randomization.
Posted
Number
Participants
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 therapy
ID
Title
Description
OG000
Any Ofatumumab (OFA)
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.
Secondary
Number of Participants With Any Adverse Event (AE) of Special Interest
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.
Safety Population: all participants who received at least one dose of any study treatment (OFA or PC) at the first randomization.
Posted
Number
Participants
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 therapy
ID
Title
Description
OG000
Any Ofatumumab (OFA)
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.
Secondary
Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time
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.
Safety Population: all participants who received at least one dose of any study treatment (OFA or PC) at the first randomization.
Posted
Mean
Standard Deviation
Gram per liter
Screening and every 3 months during treatment, every 6 months after last treatment until PD or until 42 Month Follow-up Visit
ID
Title
Description
OG000
Any Ofatumumab (OFA)
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.
Secondary
Number of Participants Who Were Positive or Negative for Human Anti-Human Antibodies (HAHA) Post-OFA Therapy
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.
Safety Population. Only those participants with post-OFA treatment HAHA results were analyzed.
Posted
Number
Participants
From the randomization date up to 60 months post the randomization date.
ID
Title
Description
OG000
Any Ofatumumab (OFA)
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.
Secondary
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)
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.
Intent-to-treat (ITT) population: all participants who were randomised to receive OFA or PC at the first randomisation.
Posted
Mean
Standard Deviation
unit on a scale
From the randomization date up to 60 months post the randomization date.
ID
Title
Description
OG000
Any Ofatumumab (OFA)
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.
Secondary
Mean Health Change Questionnaire (HCQ) Score
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..
Population Description:
Intent-to-treat (ITT) population: all participants who were randomised to receive OFA or PC at the first randomisation.
Posted
Mean
Standard Deviation
Unit on a scale
From the randomization date up to 60 months post the randomization date.
ID
Title
Description
OG000
Any Ofatumumab (OFA)
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.
Time Frame
SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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.
16
78
43
78
63
78
EG001
Ofatumumab Extended
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.
2
24
12
24
20
24
EG002
Ofatumumab Observation
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.
3
13
5
13
10
13
EG003
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. 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.
11
41
26
41
33
41
EG004
Physicians Choice
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
8
43
23
43
30
43
EG005
Ofatumumab Salvage
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.
5
22
10
22
13
22
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG0031 affected41 at risk
EG0044 affected43 at risk
EG0052 affected22 at risk
Autoimmune haemolytic anaemia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0007 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0011 affected24 at risk
EG0020 affected13 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected78 at risk
EG0011 affected24 at risk
EG0020 affected13 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Cardiovascular insufficiency
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Coronary artery insufficiency
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Hypercalcaemia of malignancy
Endocrine disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Chorioretinal atrophy
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0011 affected24 at risk
EG0020 affected13 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Diverticulum intestinal haemorrhagic
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0011 affected24 at risk
EG0020 affected13 at risk
EG003
Chills
General disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Death
General disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
General physical health deterioration
General disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0011 affected24 at risk
EG0020 affected13 at risk
EG003
Oedema peripheral
General disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Pyrexia
General disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0011 affected24 at risk
EG0020 affected13 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Hepatitis toxic
Hepatobiliary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Abscess neck
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0011 affected24 at risk
EG0020 affected13 at risk
EG003
Atypical pneumonia
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0011 affected24 at risk
EG0020 affected13 at risk
EG003
Bronchopulmonary aspergillosis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0002 affected78 at risk
EG0011 affected24 at risk
EG0020 affected13 at risk
EG003
Device related infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Empyema
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0011 affected24 at risk
EG0020 affected13 at risk
EG003
Gastrointestinal fungal infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Hepatitis B
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0011 affected24 at risk
EG0020 affected13 at risk
EG003
Hepatitis E
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Lung infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Meningitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0002 affected78 at risk
EG0011 affected24 at risk
EG0020 affected13 at risk
EG003
Meningitis aseptic
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0011 affected24 at risk
EG0020 affected13 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Otosalpingitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG00010 affected78 at risk
EG0013 affected24 at risk
EG0021 affected13 at risk
EG003
Progressive multifocal leukoencephalopathy
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Pseudomembranous colitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Sepsis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Skin infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0003 affected78 at risk
EG0011 affected24 at risk
EG0021 affected13 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Viral infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Viral tonsillitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Blood pressure decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
C-reactive protein increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Large cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Chorea
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0011 affected24 at risk
EG0020 affected13 at risk
EG003
Seizure
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0011 affected24 at risk
EG0020 affected13 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Bronchitis chronic
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0011 affected24 at risk
EG0020 affected13 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Hydrothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Obstructive airways disorder
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0011 affected24 at risk
EG0020 affected13 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected78 at risk
EG0011 affected24 at risk
EG0020 affected13 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0011 affected24 at risk
EG0020 affected13 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Hypotension
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0005 affected78 at risk
EG0012 affected24 at risk
EG0020 affected13 at risk
EG0033 affected41 at risk
EG0045 affected43 at risk
EG0051 affected22 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Lymphocytosis
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG00015 affected78 at risk
EG00110 affected24 at risk
EG0021 affected13 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (19.0)
Systematic Assessment
EG0008 affected78 at risk
EG0013 affected24 at risk
EG0021 affected13 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected78 at risk
EG0012 affected24 at risk
EG0020 affected13 at risk
EG003
Ear congestion
Ear and labyrinth disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected78 at risk
EG0011 affected24 at risk
EG0021 affected13 at risk
EG003
Visual impairment
Eye disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected78 at risk
EG0012 affected24 at risk
EG0020 affected13 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected78 at risk
EG0011 affected24 at risk
EG0021 affected13 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0005 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0008 affected78 at risk
EG0012 affected24 at risk
EG0021 affected13 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Asthenia
General disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Chills
General disorders
MedDRA (19.0)
Systematic Assessment
EG0009 affected78 at risk
EG0011 affected24 at risk
EG0022 affected13 at risk
EG003
Fatigue
General disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Oedema peripheral
General disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Peripheral swelling
General disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected78 at risk
EG0011 affected24 at risk
EG0020 affected13 at risk
EG003
Pyrexia
General disorders
MedDRA (19.0)
Systematic Assessment
EG0008 affected78 at risk
EG0012 affected24 at risk
EG0021 affected13 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0007 affected78 at risk
EG0015 affected24 at risk
EG0020 affected13 at risk
EG003
Cytomegalovirus infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Eye infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0002 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Fungal infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Laryngitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0005 affected78 at risk
EG0013 affected24 at risk
EG0021 affected13 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0004 affected78 at risk
EG0013 affected24 at risk
EG0020 affected13 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Sialoadenitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0004 affected78 at risk
EG0012 affected24 at risk
EG0021 affected13 at risk
EG003
Tracheitis
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0004 affected78 at risk
EG0010 affected24 at risk
EG0022 affected13 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (19.0)
Systematic Assessment
EG0003 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (19.0)
Systematic Assessment
EG0003 affected78 at risk
EG0012 affected24 at risk
EG0021 affected13 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0004 affected78 at risk
EG0011 affected24 at risk
EG0021 affected13 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0003 affected78 at risk
EG0011 affected24 at risk
EG0021 affected13 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0002 affected78 at risk
EG0011 affected24 at risk
EG0021 affected13 at risk
EG003
Weight decreased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Weight increased
Investigations
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0000 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected78 at risk
EG0011 affected24 at risk
EG0020 affected13 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected78 at risk
EG0012 affected24 at risk
EG0020 affected13 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected78 at risk
EG0010 affected24 at risk
EG0022 affected13 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected78 at risk
EG0011 affected24 at risk
EG0020 affected13 at risk
EG003
Intervertebral disc disorder
Musculoskeletal and connective tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Headache
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0002 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Muscle spasticity
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG00011 affected78 at risk
EG0013 affected24 at risk
EG0022 affected13 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected78 at risk
EG0011 affected24 at risk
EG0021 affected13 at risk
EG003
Nasal obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (19.0)
Systematic Assessment
EG0004 affected78 at risk
EG0010 affected24 at risk
EG0022 affected13 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected78 at risk
EG0011 affected24 at risk
EG0021 affected13 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0005 affected78 at risk
EG0010 affected24 at risk
EG0020 affected13 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected78 at risk
EG0011 affected24 at risk
EG0021 affected13 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0001 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected78 at risk
EG0012 affected24 at risk
EG0021 affected13 at risk
EG003
Flushing
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0003 affected78 at risk
EG0010 affected24 at risk
EG0021 affected13 at risk
EG003
Hypertension
Vascular disorders
MedDRA (19.0)
Systematic Assessment
EG0005 affected78 at risk
EG0012 affected24 at risk
EG0020 affected13 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Clinical Disclosure Office
Novartis Pharmaceuticals
862-778-8300
novartis.email@novartis.com
ID
Term
D007938
Leukemia
D000092122
Bronchiolitis Obliterans Syndrome
D015451
Leukemia, Lymphocytic, Chronic, B-Cell
D009369
Neoplasms
Ancestor Terms
ID
Term
D009370
Neoplasms by Histologic Type
D006402
Hematologic Diseases
D006425
Hemic and Lymphatic Diseases
D000092124
Organizing Pneumonia
D001989
Bronchiolitis Obliterans
D001988
Bronchiolitis
D001991
Bronchitis
D001982
Bronchial Diseases
D012140
Respiratory Tract Diseases
D008173
Lung Diseases, Obstructive
D008171
Lung Diseases
D006086
Graft vs Host Disease
D007154
Immune System Diseases
D015448
Leukemia, B-Cell
D007945
Leukemia, Lymphoid
D008232
Lymphoproliferative Disorders
D008206
Lymphatic Diseases
D007160
Immunoproliferative Disorders
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C527517
ofatumumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
0 subjects
27 subjects
15 subjects
0 subjects
FG0048 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0043 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0044 subjects
66.7
± 5.99
BG00463.2± 9.52
BG00562.8± 9.28
9
BG0032
BG00413
BG00562
Male
BG00055
BG00129
BG00215
BG00311
BG00429
BG005139
0
BG0030
BG0041
BG0052
Not Hispanic or Latino
Title
Measurements
BG00078
BG00143
BG00224
BG00313
BG00441
BG005199
OG003
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.
13
7.16
(5.36 to 9.49)
OG003
Log Rank
P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum
0.0837
Hazard Ratio (HR)
0.54
2-Sided
95
0.19
1.53
Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum
Superiority or Other
OG001
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.
OG002
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.
OG003
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.
Units
Counts
Participants
OG00079
OG00143
OG00224
OG00313
Title
Denominators
Categories
Title
Measurements
OG0007.00(5.42 to 8.25)
OG0014.50(1.97 to 5.62)
OG00212.68(10.09 to 14.29)
OG0039.49(7.00 to 12.12)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum
0.0030
Hazard Ratio (HR)
0.56
2-Sided
95
0.35
0.87
Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum.
Superiority or Other
OG002
OG003
Log Rank
P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum
0.0262
Hazard Ratio (HR)
0.49
2-Sided
95
0.21
1.17
Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum
Superiority or Other
OG001
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.
OG002
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.
OG003
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.
Units
Counts
Participants
OG00079
OG00143
OG00224
OG00313
Title
Denominators
Categories
CR
Title
Measurements
OG0000
OG0010
OG0020
OG0030
PR
Title
Measurements
OG00030
OG0017
OG00218
OG003
nPR
Title
Measurements
OG0000
OG0010
OG0020
OG003
Stable Disease
Title
Measurements
OG00036
OG00122
OG0025
OG003
Progressive Disease
Title
Measurements
OG0009
OG0018
OG0021
OG003
Not Evaluable
Title
Measurements
OG0004
OG0016
OG0020
OG003
Missing
Title
Measurements
OG0000
OG0010
OG0020
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
conditional logistic regression with interval and pooled stratum
0.0223
Odds Ratio (OR)
2.942
2-Sided
95
1.166
7.424
Superiority or Other
OG002
OG003
Regression, Logistic
conditional logistic regression with interval and pooled stratum
0.9985
Odds Ratio (OR)
999.999
2-Sided
95
0.001
999.999
Superiority or Other
OG001
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.
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00079
OG00143
OG00224
OG00313
OG00442
Title
Denominators
Categories
CR
Title
Measurements
OG0002
OG0012
OG0021
OG0031
OG0040
PR
Title
Measurements
OG00036
OG00112
OG00217
OG003
nPR
Title
Measurements
OG0001
OG0012
OG0020
OG003
Stable Disease
Title
Measurements
OG00034
OG00114
OG0026
OG003
Progressive Disease
Title
Measurements
OG0002
OG00110
OG0020
OG003
Not Evaluable
Title
Measurements
OG0000
OG0010
OG0020
OG003
Missing
Title
Measurements
OG0004
OG0013
OG0020
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.4159
Odds ratios and p-value are based on conditional logistic regression with interval and pooled stratum included in the Strata statement
Odds Ratio (OR)
1.366
2-Sided
95
0.644
2.899
Superiority or Other
OG002
OG003
Regression, Logistic
0.8866
Odds ratios and p-value are based on conditional logistic regression with interval and pooled stratum in the strata statement
Odds Ratio (OR)
1.225
2-Sided
95
0.076
19.862
Superiority or Other
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00079
OG00143
OG00224
OG00313
OG00442
Title
Denominators
Categories
Title
Measurements
OG00019.19(12.19 to 29.11)
OG00114.52(8.94 to 24.97)
OG00231.54(19.19 to 51.25)
OG00345.50(14.69 to NA)N/A = The upper limit of the 95% CI is not available due to the sparcity of the data.
OG0048.57(4.93 to 16.76)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum
0.1732
Hazard Ratio (HR)
0.75
2-Sided
95
0.48
1.17
Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum
Superiority or Other
OG002
OG003
Log Rank
0.8128
P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum
Hazard Ratio (HR)
1.11
2-Sided
95
0.46
2.68
Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum
Superiority or Other
OG001
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.
OG002
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.
OG003
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.
Units
Counts
Participants
OG00056
OG00123
OG00219
OG00311
Title
Denominators
Categories
Title
Measurements
OG0006.31(4.83 to 7.33)
OG0015.32(2.14 to 8.08)
OG00210.05(7.23 to 13.80)
OG0037.16(5.36 to 9.49)
OG002
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.
OG003
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.
Units
Counts
Participants
OG00044
OG00129
OG00212
OG00312
Title
Denominators
Categories
Title
Measurements
OG00011.50(8.51 to 13.80)
OG0016.54(2.66 to 8.08)
OG00215.47(11.86 to NA)The upper limit of the 95% CI is not available due to the sparcity of the data.
OG0039.00(8.08 to 14.16)
OG001
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.
OG002
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.
OG003
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.
Units
Counts
Participants
OG00030
OG0017
OG00218
OG0038
Title
Denominators
Categories
Title
Measurements
OG0001.17(1.02 to 1.91)
OG0012.56(0.76 to 3.48)
OG0021.86(1.05 to 1.94)
OG0031.15(0.92 to 1.94)
OG001
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.
Units
Counts
Participants
OG00023
OG0015
Title
Denominators
Categories
Title
Measurements
OG0006.24(5.32 to 12.22)
OG0016.95(4.47 to NA)The upper limit of the 95% CI is not available due to the sparcity of the data.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG00078
OG00143
OG00224
OG00313
OG00441
OG00522
Title
Denominators
Categories
Any AE
Title
Measurements
OG00071
OG00137
OG00222
OG00310
OG00439
OG00520
Any SAE
Title
Measurements
OG00043
OG00123
OG00212
OG003
Any FSAE
Title
Measurements
OG00014
OG0016
OG0022
OG003
Deaths
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG001
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.
OG002
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.
OG003
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.
Units
Counts
Participants
OG00078
OG00143
OG00224
OG00313
Title
Denominators
Categories
Any AE of decreased neutrophil count
Title
Measurements
OG00023
OG00115
OG00211
OG0032
Any AE of decreased hemoglobin
Title
Measurements
OG0009
OG0019
OG0023
OG003
Any AE of decreased platelet count
Title
Measurements
OG00010
OG0015
OG0023
OG003
Any AE of autoimmune haemolytic anaemia
Title
Measurements
OG0000
OG0012
OG0020
OG003
Any AE of haemolytic anaemia
Title
Measurements
OG0001
OG0010
OG0021
OG003
Any infusion related AE
Title
Measurements
OG00033
OG00111
OG0028
OG003
Any AE of Infection
Title
Measurements
OG00046
OG00124
OG00216
OG003
Any AE of mucocutaneous reaction
Title
Measurements
OG00020
OG0014
OG0026
OG003
Any AE of TLS
Title
Measurements
OG0001
OG0011
OG0020
OG003
Any AE of cardiovascular events
Title
Measurements
OG00013
OG0013
OG0026
OG003
Any AE of small bowel obstruction
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG00078
OG00143
OG00224
OG00313
OG00441
OG00522
Title
Denominators
Categories
IgA, SCR
ParticipantsOG00078
ParticipantsOG00141
ParticipantsOG00224
ParticipantsOG00313
ParticipantsOG00441
ParticipantsOG0050
Title
Measurements
OG0000.793± 0.6680
OG0010.685± 0.5518
OG0020.807± 0.7426
OG003
IgG, SCR
ParticipantsOG00078
ParticipantsOG00141
ParticipantsOG00224
ParticipantsOG00313
IgM, SCR
ParticipantsOG00077
ParticipantsOG00141
ParticipantsOG00224
ParticipantsOG00313
IgA, C3W4
ParticipantsOG00061
ParticipantsOG00123
ParticipantsOG00224
ParticipantsOG00312
IgG, C3W4
ParticipantsOG00061
ParticipantsOG00123
ParticipantsOG00224
ParticipantsOG00312
IgM, C3W4
ParticipantsOG00061
ParticipantsOG00123
ParticipantsOG00224
ParticipantsOG00312
IgA, C7W4
ParticipantsOG00038
ParticipantsOG0010
ParticipantsOG00224
ParticipantsOG00312
IgG, C7W4
ParticipantsOG00038
ParticipantsOG0010
ParticipantsOG00224
ParticipantsOG00310
IgM, C7W4
ParticipantsOG00038
ParticipantsOG0010
ParticipantsOG00224
ParticipantsOG00312
IgA, C9W4
ParticipantsOG00029
ParticipantsOG0010
ParticipantsOG00221
ParticipantsOG0038
IgG, C9W4
ParticipantsOG00029
ParticipantsOG0010
ParticipantsOG00221
ParticipantsOG0038
IgM, C9W4
ParticipantsOG00029
ParticipantsOG0010
ParticipantsOG00221
ParticipantsOG0038
IgA, 6M FU
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
IgG, 6M FU
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
IgM, 6M FU
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
IgA, 9M FU
ParticipantsOG0002
ParticipantsOG0015
ParticipantsOG0022
ParticipantsOG0030
IgG, 9M FU
ParticipantsOG0002
ParticipantsOG0015
ParticipantsOG0022
ParticipantsOG0030
IgM, 9M FU
ParticipantsOG0002
ParticipantsOG0015
ParticipantsOG0022
ParticipantsOG0030
IgA, 12M FU
ParticipantsOG00010
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0033
IgG, 12M FU
ParticipantsOG00010
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0033
IgM, 12M FU
ParticipantsOG00010
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0033
IgA, 18M FU
ParticipantsOG0008
ParticipantsOG0012
ParticipantsOG0027
ParticipantsOG0031
IgG, 18M FU
ParticipantsOG0008
ParticipantsOG0012
ParticipantsOG0027
ParticipantsOG0031
IgM, 18M FU
ParticipantsOG0008
ParticipantsOG0012
ParticipantsOG0027
ParticipantsOG0031
IgA, 24M FU
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0031
IgG, 24M FU
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0031
IgM, 24M FU
ParticipantsOG0005
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0031
IgA, 30M FU
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0030
IgG, 30M FU
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0030
IgM, 30M FU
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0030
IgA, 36M FU
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0030
IgG, 36M FU
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0030
IgM, 36M FU
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0030
IgA, 42M FU
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0030
IgG, 42M FU
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0030
IgM, 42M FU
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0030
OG001
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.
OG002
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.
OG003
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.
OG004
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.
Units
Counts
Participants
OG00078
OG00124
OG00213
OG00341
OG00422
Title
Denominators
Categories
CNF Pos
ParticipantsOG00069
ParticipantsOG00124
ParticipantsOG00213
ParticipantsOG00332
ParticipantsOG00419
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neg and no OFA concentration <200 ug/mL
ParticipantsOG00069
ParticipantsOG00124
ParticipantsOG00213
ParticipantsOG00332
Neg and at least one OFA concentration <200 ug/mL
ParticipantsOG00069
ParticipantsOG00124
ParticipantsOG00213
ParticipantsOG003
OG001
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.
OG002
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.
OG003
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.
Units
Counts
Participants
OG00079
OG00143
OG00224
OG00313
Title
Denominators
Categories
DES, C3W4
ParticipantsOG00059
ParticipantsOG00121
ParticipantsOG00224
ParticipantsOG00312
Title
Measurements
OG000-10.3± 17.60
OG001-6.3± 16.22
OG002-9.7± 12.20
OG003
DES, C6W4
ParticipantsOG00044
ParticipantsOG00113
ParticipantsOG00224
ParticipantsOG00311
DES, C9W4
ParticipantsOG00028
ParticipantsOG0010
ParticipantsOG00220
ParticipantsOG0038
DES, C12W4
ParticipantsOG00015
ParticipantsOG0010
ParticipantsOG00215
ParticipantsOG0030
DES, 3MFU
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
DES, 5MFU
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
DES, 6MFU
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
DES, 7MFU
ParticipantsOG0000
ParticipantsOG0018
ParticipantsOG0020
ParticipantsOG0030
DES, 9MFU
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG0030
DES, 11MFU
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0021
ParticipantsOG0030
DES, 12MFU
ParticipantsOG00010
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0032
DES, 15MFU
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0030
DES, 18MFU
ParticipantsOG0005
ParticipantsOG0012
ParticipantsOG0025
ParticipantsOG0030
DES, 21MFU
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0030
DES, 24MFU
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0030
DES, 27MFU
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
DES, 30MFU
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Fatigue Scale, C3W4
ParticipantsOG00059
ParticipantsOG00121
ParticipantsOG00224
ParticipantsOG00312
Fatigue Scale, C6W4
ParticipantsOG00044
ParticipantsOG00113
ParticipantsOG00224
ParticipantsOG00311
Fatigue Scale, C9W4
ParticipantsOG00028
ParticipantsOG0010
ParticipantsOG00220
ParticipantsOG0038
Fatigue Scale, C12W4
ParticipantsOG00015
ParticipantsOG0010
ParticipantsOG00215
ParticipantsOG0030
Fatigue Scale, 3MFU
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Fatigue Scale, 5MFU
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Fatigue Scale, 6MFU
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Fatigue Scale, 7MFU
ParticipantsOG0000
ParticipantsOG0018
ParticipantsOG0020
ParticipantsOG0030
Fatigue Scale, 9MFU
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG0030
Fatigue Scale, 11MFU
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0021
ParticipantsOG0030
Fatigue Scale,12MFU
ParticipantsOG00010
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0032
Fatigue Scale, 15MFU
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0030
Fatigue Scale, 18MFU
ParticipantsOG0005
ParticipantsOG0012
ParticipantsOG0025
ParticipantsOG0030
Fatigue Scale, 21MFU
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0030
Fatigue Scale, 24MFU
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0030
Fatigue Scale, 27MFU
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Fatigue Scale, 30MFU
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Future Health Scale, C3W4
ParticipantsOG00058
ParticipantsOG00121
ParticipantsOG00224
ParticipantsOG00311
Future Health Scale, C6W4
ParticipantsOG00044
ParticipantsOG00113
ParticipantsOG00224
ParticipantsOG00311
Future Health Scale, C9W4
ParticipantsOG00028
ParticipantsOG0010
ParticipantsOG00220
ParticipantsOG0038
Future Health Scale, C12W4
ParticipantsOG00015
ParticipantsOG0010
ParticipantsOG00215
ParticipantsOG0030
Future Health Scale, 3MFU
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Future Health Scale, 5MFU
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Future Health Scale, 6MFU
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Future Health Scale, 7MFU
ParticipantsOG0000
ParticipantsOG0018
ParticipantsOG0020
ParticipantsOG0030
Future Health Scale, 9MFU
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG0030
Future Health Scale, 11MFU
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0021
ParticipantsOG0030
Future Health Scale, 12MFU
ParticipantsOG00010
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0032
Future Health Scale, 15MFU
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0030
Future Health Scale, 18MFU
ParticipantsOG0005
ParticipantsOG0012
ParticipantsOG0025
ParticipantsOG0030
Future Health Scale, 21MFU
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0030
Future Health Scale, 24MFU
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0030
Future Health Scale, 27MFU
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Future Health Scale, 30MFU
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Infection Scale, C3W4
ParticipantsOG00059
ParticipantsOG00121
ParticipantsOG00224
ParticipantsOG00312
Infection Scale, C6W4
ParticipantsOG00044
ParticipantsOG00113
ParticipantsOG00224
ParticipantsOG00311
Infection Scale,C9W4
ParticipantsOG00028
ParticipantsOG0010
ParticipantsOG00220
ParticipantsOG0038
Infection Scale, C12W4
ParticipantsOG00015
ParticipantsOG0010
ParticipantsOG00215
ParticipantsOG0030
Infection Scale, 3MFU
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Infection Scale, 5MFU
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Infection Scale, 6MFU
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
Infection Scale, 7MFU
ParticipantsOG0000
ParticipantsOG0018
ParticipantsOG0020
ParticipantsOG0030
Infection Scale, 9MFU
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG0030
Infection Scale, 11MFU
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0021
ParticipantsOG0030
Infection Scale, 12MFU
ParticipantsOG00010
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0032
Infection Scale, 15MFU
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0030
Infection Scale, 18MFU
ParticipantsOG0005
ParticipantsOG0012
ParticipantsOG0025
ParticipantsOG0030
Infection Scale, 21MFU
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0030
Infection Scale, 24MFU
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0030
Infection Scale, 27MFU
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Infection Scale, 30MFU
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
SP Scale, C3W4
ParticipantsOG00059
ParticipantsOG00121
ParticipantsOG00224
ParticipantsOG00312
SP Scale, C6W4
ParticipantsOG00044
ParticipantsOG00113
ParticipantsOG00224
ParticipantsOG00311
SP Scale, C9W4
ParticipantsOG00028
ParticipantsOG0010
ParticipantsOG00220
ParticipantsOG0038
SP Scale, C12W4
ParticipantsOG00015
ParticipantsOG0010
ParticipantsOG00215
ParticipantsOG0030
SP Scale, 3MFU
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
SP Scale, 5MFU
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
SP Scale, 6MFU
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
SP Scale, 7MFU
ParticipantsOG0000
ParticipantsOG0018
ParticipantsOG0020
ParticipantsOG0030
SP Scale, 9MFU
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG0030
SP Scale, 11MFU
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0021
ParticipantsOG0030
SP Scale, 12MFU
ParticipantsOG00010
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0032
SP Scale, 15MFU
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0030
SP Scale, 18MFU
ParticipantsOG0005
ParticipantsOG0012
ParticipantsOG0025
ParticipantsOG0030
SP Scale, 21MFU
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0030
SP Scale, 24MFU
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0030
SP Scale, 27MFU
ParticipantsOG0001
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0030
SP Scale, 30MFU
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
TSE Scale, C3W4
ParticipantsOG00059
ParticipantsOG00121
ParticipantsOG00224
ParticipantsOG00312
TSE Scale, C6W4
ParticipantsOG00044
ParticipantsOG00113
ParticipantsOG00224
ParticipantsOG00311
TSE Scale, C9W4
ParticipantsOG00028
ParticipantsOG0010
ParticipantsOG00220
ParticipantsOG0038
TSE Scale, C12W4
ParticipantsOG00015
ParticipantsOG0010
ParticipantsOG00215
ParticipantsOG0030
TSE Scale, 3MFU
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
TSE Scale, 5MFU
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
TSE Scale, 6MFU
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
TSE Scale, 7MFU
ParticipantsOG0000
ParticipantsOG0018
ParticipantsOG0020
ParticipantsOG0030
TSE Scale, 9MFU
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG0030
TSE Scale, 11MFU
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0021
ParticipantsOG0030
TSE Scale, 12MFU
ParticipantsOG00010
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0032
TSE Scale, 15MFU
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG0030
TSE Scale, 18MFU
ParticipantsOG0005
ParticipantsOG0012
ParticipantsOG0025
ParticipantsOG0030
TSE Scale, 21MFU
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0030
TSE Scale, 24MFU
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0030
TSE Scale, 27MFU
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
TSE Scale, 30MFU
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
Units
Counts
Participants
OG00079
OG00143
OG00224
OG00313
OG00442
OG00522
Title
Denominators
Categories
C3W4
ParticipantsOG00060
ParticipantsOG00121
ParticipantsOG00224
ParticipantsOG00312
ParticipantsOG00424
ParticipantsOG00517
Title
Measurements
OG0002.8± 1.57
OG0013.9± 2.01
OG0022.5± 1.44
OG003
C6W4
ParticipantsOG00044
ParticipantsOG00113
ParticipantsOG00224
ParticipantsOG00311
C9W4
ParticipantsOG00028
ParticipantsOG0010
ParticipantsOG00220
ParticipantsOG0038
C12W4
ParticipantsOG00014
ParticipantsOG0010
ParticipantsOG00214
ParticipantsOG0030
3MFU
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
5MFU
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
6MFU
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
7MFU
ParticipantsOG0000
ParticipantsOG0018
ParticipantsOG0020
ParticipantsOG0030
9MFU
ParticipantsOG0002
ParticipantsOG0016
ParticipantsOG0022
ParticipantsOG0030
11MFU
ParticipantsOG0001
ParticipantsOG0015
ParticipantsOG0021
ParticipantsOG0030
12MFU
ParticipantsOG00010
ParticipantsOG0013
ParticipantsOG0028
ParticipantsOG0032
15MFU
ParticipantsOG00010
ParticipantsOG0013
ParticipantsOG0029
ParticipantsOG0031
18MFU
ParticipantsOG0007
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0031
21MFU
ParticipantsOG0005
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0031
24MFU
ParticipantsOG0004
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0031
27MFU
ParticipantsOG0003
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0031
30MFU
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0030
33MFU
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0030
36MFU
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0030
39MFU
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0030
42MFU
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0030
45MFU
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0030
0 affected
41 at risk
EG0042 affected43 at risk
EG0051 affected22 at risk
6 affected
41 at risk
EG0044 affected43 at risk
EG0051 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
2 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
2 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0052 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0051 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0051 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
4 affected
41 at risk
EG0043 affected43 at risk
EG0052 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0051 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0051 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0051 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0051 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0042 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0051 affected22 at risk
6 affected
41 at risk
EG0047 affected43 at risk
EG0053 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0044 affected43 at risk
EG0052 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0051 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0051 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0051 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
2 affected
41 at risk
EG0041 affected43 at risk
EG0051 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0051 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
2 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
4 affected
41 at risk
EG0048 affected43 at risk
EG0053 affected22 at risk
4 affected
41 at risk
EG0043 affected43 at risk
EG0051 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
2 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0041 affected43 at risk
EG0051 affected22 at risk
5 affected
41 at risk
EG0044 affected43 at risk
EG0052 affected22 at risk
5 affected
41 at risk
EG0045 affected43 at risk
EG0051 affected22 at risk
4 affected
41 at risk
EG0043 affected43 at risk
EG0050 affected22 at risk
3 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
6 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
2 affected
41 at risk
EG0044 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0043 affected43 at risk
EG0050 affected22 at risk
3 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
5 affected
41 at risk
EG0043 affected43 at risk
EG0052 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
2 affected
41 at risk
EG0043 affected43 at risk
EG0051 affected22 at risk
0 affected
41 at risk
EG0044 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0051 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0042 affected43 at risk
EG0051 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
2 affected
41 at risk
EG0045 affected43 at risk
EG0052 affected22 at risk
3 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
2 affected
41 at risk
EG0041 affected43 at risk
EG0051 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0051 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0042 affected43 at risk
EG0052 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0051 affected22 at risk
3 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0052 affected22 at risk
3 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0042 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
3 affected
41 at risk
EG0041 affected43 at risk
EG0051 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0052 affected22 at risk
3 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
2 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
6 affected
41 at risk
EG0041 affected43 at risk
EG0052 affected22 at risk
1 affected
41 at risk
EG0042 affected43 at risk
EG0051 affected22 at risk
0 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
2 affected
41 at risk
EG0040 affected43 at risk
EG0051 affected22 at risk
1 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
5 affected
41 at risk
EG0042 affected43 at risk
EG0050 affected22 at risk
1 affected
41 at risk
EG0042 affected43 at risk
EG0052 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
0 affected
41 at risk
EG0041 affected43 at risk
EG0050 affected22 at risk
2 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
3 affected
41 at risk
EG0040 affected43 at risk
EG0050 affected22 at risk
8
0
5
0
0
0
7
OG00412
1
OG0040
4
OG00424
0
OG0042
0
OG0040
0
OG0044
5
OG00426
OG00510
3
OG0049
OG0055
0
OG0041
OG0050
2
1
0
0
4
8
3
0
0
0
1.095
± 0.7535
OG0040.688± 0.5749
Participants
OG004
41
ParticipantsOG0050
Title
Measurements
OG0006.909± 4.6836
OG0018.615± 12.1625
OG0026.270± 3.8573
OG0038.128± 4.7569
OG0046.898± 5.1142
Participants
OG004
40
ParticipantsOG0050
Title
Measurements
OG0000.800± 1.3154
OG0010.601± 0.7061
OG0020.800± 1.6649
OG0030.468± 0.3801
OG0040.907± 1.2822
Participants
OG004
25
ParticipantsOG00517
Title
Measurements
OG0000.721± 0.6355
OG0010.675± 0.4819
OG0020.808± 0.7931
OG0030.977± 0.6458
OG0040.514± 0.3621
OG0050.486± 0.3868
Participants
OG004
25
ParticipantsOG00517
Title
Measurements
OG0005.925± 3.5059
OG0015.481± 2.1226
OG0025.949± 3.4089
OG0037.232± 4.0103
OG0045.276± 3.3056
OG0055.974± 2.7992
Participants
OG004
25
ParticipantsOG00517
Title
Measurements
OG0000.692± 1.3420
OG0010.485± 0.4929
OG0020.882± 1.9833
OG0030.429± 0.3497
OG0040.636± 0.7764
OG0050.488± 0.4816
Participants
OG004
2
ParticipantsOG00510
Title
Measurements
OG0000.793± 0.6608
OG0020.723± 0.6730
OG0030.945± 0.6724
OG0040.725± 0.6011
OG0050.537± 0.4356
Participants
OG004
2
ParticipantsOG00510
Title
Measurements
OG0006.250± 3.5225
OG0025.817± 3.4944
OG0037.254± 3.7588
OG0045.420± 2.2062
OG0055.135± 2.6309
Participants
OG004
2
ParticipantsOG00510
Title
Measurements
OG0000.762± 1.7523
OG0020.844± 2.1136
OG0030.414± 0.3400
OG0041.865± 2.3547
OG0050.447± 0.4732
Participants
OG004
0
ParticipantsOG0057
Title
Measurements
OG0000.719± 0.6336
OG0020.630± 0.6005
OG0030.952± 0.6997
OG0050.567± 0.3968
Participants
OG004
0
ParticipantsOG0057
Title
Measurements
OG0006.164± 3.5886
OG0025.553± 3.0792
OG0037.768± 4.5126
OG0055.709± 2.1629
Participants
OG004
0
ParticipantsOG0057
Title
Measurements
OG0000.853± 2.3484
OG0020.973± 2.7574
OG0030.536± 0.4209
OG0050.484± 0.4493
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0010.880± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0018.670± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0010.200± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0000.890± 0.0849
OG0010.510± 0.4585
OG0020.890± 0.0849
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0007.695± 0.9263
OG0015.016± 2.4292
OG0027.695± 0.9263
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0000.375± 0.1061
OG0010.246± 0.0706
OG0020.375± 0.1061
Participants
OG004
0
ParticipantsOG0052
Title
Measurements
OG0000.721± 0.8339
OG0010.983± 0.6029
OG0020.826± 0.9960
OG0030.477± 0.1595
OG0050.300± 0.000
Participants
OG004
0
ParticipantsOG0052
Title
Measurements
OG0006.423± 3.5390
OG0017.497± 1.5550
OG0027.621± 3.3834
OG0033.627± 2.2938
OG0054.935± 0.8273
Participants
OG004
0
ParticipantsOG0052
Title
Measurements
OG0000.384± 0.3463
OG0010.487± 0.2743
OG0020.3334± 0.2833
OG0030.500± 0.5197
OG0050.240± 0.0566
Participants
OG004
0
ParticipantsOG0052
Title
Measurements
OG0000.520± 0.2803
OG0011.095± 0.2616
OG0020.500± 0.2965
OG0030.660± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0050.300± 0.000
Participants
OG004
0
ParticipantsOG0052
Title
Measurements
OG0004.513± 2.0789
OG0016.620± 2.3759
OG0024.206± 2.0405
OG0036.660± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0054.265± 1.1384
Participants
OG004
0
ParticipantsOG0052
Title
Measurements
OG0000.417± 3.3156
OG0010.640± 0.2687
OG0020.317± 0.1490
OG0031.120± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0050.240± 0.0566
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0000.540± 0.2667
OG0011.540± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0020.480± 0.2662
OG0030.780± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0005.634± 2.4734
OG00110.900± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0025.098± 2.4977
OG0037.780± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0000.490± 0.3621
OG0011.710± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0020.333± 0.0971
OG0031.120± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0000.505± 0.2900
OG0011.380± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0020.505± 0.2900
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0003.460± 1.8809
OG00111.100± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0023.460± 1.8809
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0000.400± 0.1131
OG0010.770± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0020.400± 0.1131
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0000.550± 0.3111
OG0011.680± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0020.550± 0.3111
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0004.320± 2.2486
OG00113.600± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0024.320± 2.2486
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0001.175± 0.2899
OG0010.720± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0021.175± 0.2899
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0000.545± 0.2051
OG0011.410± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0020.545± 0.2051
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0004.425± 3.5143
OG00111.500± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0024.425± 3.5143
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0002.155± 0.8697
OG0010.470± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0022.155± 0.8697
0
OG0040
ParticipantsOG00419
Title
Measurements
OG00012
OG0011
OG0021
OG00310
OG0044
32
ParticipantsOG00419
Title
Measurements
OG00057
OG00123
OG00212
OG00322
OG00415
-10.4
± 17.09
Title
Measurements
OG000-8.5± 15.82
OG001-6.4± 16.37
OG002-8.3± 14.95
OG003-9.8± 18.19
Title
Measurements
OG000-11± 17.72
OG002-7.5± 17.91
OG003-19.8± 14.73
Title
Measurements
OG000-3.3± 21.78
OG002-3.3± 21.78
Title
Measurements
OG0010± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG0010± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG001-14.6± 16.52
Title
Measurements
OG0000± 23.57
OG001-9.7± 9.74
OG0020± 23.57
Title
Measurements
OG000-25± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG001-6.7± 18.07
OG002-25± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG000-10.8± 14.19
OG001-2.8± 20.97
OG002-10.4± 14.6
OG003-12.5± 17.68
Title
Measurements
OG000-4.8± 13.49
OG001-5.6± 17.35
OG002-4.8± 13.49
Title
Measurements
OG000-3.3± 13.94
OG001-20.8± 17.68
OG002-3.3± 13.94
Title
Measurements
OG0005.6± 20.97
OG001-12.5± 5.89
OG0025.6± 20.97
Title
Measurements
OG0004.2± 5.89
OG0010± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0024.2± 5.89
Title
Measurements
OG0000± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0020± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG0000± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0020± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG000-4± 24.04
OG0012.4± 21.91
OG002-2.1± 19.23
OG003-12.5± 24.75
Title
Measurements
OG000-5.7± 19.99
OG00112.8± 29.78
OG002-0.7± 16.65
OG003-13.6± 19.46
Title
Measurements
OG000-4.2± 25.1
OG0020± 24.78
OG003-14.6± 24.3
Title
Measurements
OG0007.8± 33.85
OG0027.8± 33.85
Title
Measurements
OG00116.7± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG00116.7± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG001-14.6± 18.77
Title
Measurements
OG00041.7± 82.5
OG001-8.3± 22.97
OG00241.7± 82.5
Title
Measurements
OG00016.7± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG001-6.7± 19
OG002-16.7± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG0005± 20.86
OG001-22.2± 9.62
OG0026.3± 21.71
OG0030± 23.57
Title
Measurements
OG0002.4± 22.42
OG0010± 16.67
OG0022.4± 22.42
Title
Measurements
OG0003.3± 21.73
OG0010± 0
OG0023.3± 21.73
Title
Measurements
OG00016.7± 28.87
OG0010± 23.57
OG00216.7± 28.87
Title
Measurements
OG00041.7± 58.93
OG00116.7± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG00241.7± 58.93
Title
Measurements
OG0000± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0020± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG0000± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0020± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG000-6.9± 27.04
OG001-7.9± 31.46
OG002-4.2± 22.66
OG003-6.1± 29.13
Title
Measurements
OG000-12.9± 29.83
OG001-5.1± 18.49
OG002-11.1± 25.38
OG003-24.2± 39.7
Title
Measurements
OG000-14.3± 27.86
OG002-11.7± 27.09
OG003-20.8± 30.54
Title
Measurements
OG000-4.4± 39.57
OG002-4.4± 39.57
Title
Measurements
OG0010± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG00133.3± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG001-12.5± 24.8
Title
Measurements
OG0000± 47.14
OG001-22.2± 40.37
OG0020± 47.14
Title
Measurements
OG0000± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG001-13.3± 18.26
OG0020± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG000-10± 31.62
OG001-11.1± 19.25
OG002-4.2± 33.03
OG003-33.3± 0
Title
Measurements
OG00019± 17.82
OG001-11.1± 19.25
OG00219± 17.82
Title
Measurements
OG00020± 18.26
OG001-16.7± 23.57
OG00220± 18.26
Title
Measurements
OG00022.2± 19.25
OG001-16.7± 23.57
OG00222.2± 19.25
Title
Measurements
OG00033.3± 47.14
OG0010± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG00233.3± 47.14
Title
Measurements
OG0000± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0020± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG0000± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0020± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG0002.1± 23.6
OG0013.2± 19.63
OG002-1± 20.01
OG003-5.6± 12.48
Title
Measurements
OG000-3.7± 22.66
OG00112.2± 25.6
OG002-5.6± 19.91
OG003-6.8± 19.3
Title
Measurements
OG000-7.4± 18.61
OG002-7.5± 16.86
OG003-7.3± 23.75
Title
Measurements
OG000-11.7± 14.02
OG002-11.7± 14.02
Title
Measurements
OG0010± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG0018.3± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG001-9.4± 12.15
Title
Measurements
OG00016.7± 23.57
OG0010± 13.94
OG00216.7± 23.57
Title
Measurements
OG0000± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG001-6.7± 12.36
OG0020± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG000-7.5± 20.58
OG0012.8± 12.73
OG002-6.2± 20.29
OG003-12.5± 29.46
Title
Measurements
OG000-2.4± 17.82
OG001-2.8± 20.97
OG002-2.4± 17.82
Title
Measurements
OG0005± 12.64
OG001-8.3± 11.79
OG0025± 12.64
Title
Measurements
OG0002.8± 12.73
OG0018.3± 0
OG0022.8± 12.73
Title
Measurements
OG0000± 0
OG0018.3± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0020± 0
Title
Measurements
OG0000± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0020± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG0000± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0020± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG000-9± 27.56
OG0013.2± 36.37
OG002-11.1± 23.4
OG003-13.9± 30.01
Title
Measurements
OG000-10.6± 27.63
OG00110.3± 31.58
OG002-9.7± 25.02
OG003-15.2± 31.14
Title
Measurements
OG000-13.1± 27.72
OG002-11.7± 29.17
OG003-16.7± 25.2
Title
Measurements
OG000-11.1± 37.09
OG002-11.1± 37.09
Title
Measurements
OG001-33.3± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG001-66.7± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG001-16.7± 25.2
Title
Measurements
OG00016.7± 70.71
OG001-5.6± 32.77
OG00216.7± 70.71
Title
Measurements
OG000-33.3± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG001-6.7± 36.51
OG002-33.3± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG000-16.7± 23.57
OG001-22.2± 19.25
OG002-16.7± 25.2
OG003-16.7± 23.57
Title
Measurements
OG000-9.5± 37.09
OG001-11.1± 19.25
OG002-9.5± 37.09
Title
Measurements
OG0000± 23.57
OG001-16.7± 23.57
OG0020± 23.57
Title
Measurements
OG000-22.2± 38.49
OG001-16.7± 23.57
OG002-22.2± 38.49
Title
Measurements
OG00033.3± 47.14
OG0010± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG00233.3± 47.14
Title
Measurements
OG0000± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG001NA± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0020± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG0000± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0020± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG000-4.8± 15.33
OG001-1.5± 16.82
OG002-2.4± 10.85
OG003-8.3± 13.76
Title
Measurements
OG000-4.2± 14.33
OG0013.2± 12.52
OG002-0.2± 11.32
OG003-9.1± 16.44
Title
Measurements
OG000-5.4± 15.75
OG002-3.7± 13.91
OG003-9.4± 20.14
Title
Measurements
OG000-2.8± 14.66
OG002-2.8± 14.66
Title
Measurements
OG00116.7± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG00116.7± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG001-8.3± 17.82
Title
Measurements
OG0008.3± 11.79
OG001-1.4± 9.74
OG0028.3± 11.79
Title
Measurements
OG0000± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG001-1.7± 14.91
OG0020± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG000-4.2± 19.74
OG0012.8± 12.73
OG0020± 12.6
OG003-20.8± 41.25
Title
Measurements
OG000-8.3± 12.73
OG0012.8± 9.62
OG002-8.3± 12.73
Title
Measurements
OG0006.7± 16.03
OG0010± 11.79
OG0026.7± 16.03
Title
Measurements
OG0008.3± 22.05
OG0010± 0
OG0028.3± 22.05
Title
Measurements
OG0004.2± 5.89
OG0010± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0024.2± 5.89
Title
Measurements
OG0008.3± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0028.3± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Title
Measurements
OG0000± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0020± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
2.8
± 0.97
OG0043.2± 1.90
OG0053.1± 1.92
Participants
OG004
9
ParticipantsOG00512
Title
Measurements
OG0003.2± 2.04
OG0013.5± 2.37
OG0022.7± 1.66
OG0032.9± 1.76
OG0045.1± 2.37
OG0053.0± 2.00
Participants
OG004
0
ParticipantsOG0057
Title
Measurements
OG0002.8± 1.60
OG0022.5± 1.36
OG0033.5± 2.00
OG0053.1± 2.48
Participants
OG004
0
ParticipantsOG0054
Title
Measurements
OG0002.6± 1.99
OG0022.6± 1.99
OG0053.0± 1.83
Participants
OG004
0
ParticipantsOG0051
Title
Measurements
OG0053.0± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0015.0± NANo 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.
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0013.0± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0012.4± 1.30
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0006.5± 2.12
OG0013.5± 2.07
OG0026.5± 2.12
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0005.0± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0013.0± 2.35
OG0025.0± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Participants
OG004
0
ParticipantsOG0052
Title
Measurements
OG0003.4± 2.07
OG0012.3± 1.53
OG0023.5± 2.27
OG0033.0± 1.41
OG0052.0± 1.41
Participants
OG004
0
ParticipantsOG0053
Title
Measurements
OG0003.5± 2.27
OG0013.7± 1.53
OG0023.7± 2.35
OG0032.0± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0052.0± 1.00
Participants
OG004
0
ParticipantsOG0052
Title
Measurements
OG0002.6± 2.15
OG0014.5± 0.71
OG0022.8± 2.23
OG0031.0± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0054.0± 4.24
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0002.0± 1.22
OG0016.0± 1.41
OG0022.3± 1.26
OG0031.0± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0002.5± 3.00
OG0014.0± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0023.0± 3.46
OG0031.0± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0002.7± 2.89
OG0015.0± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0023.5± 3.54
OG0031.0± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0001.0± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0015.0± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0021.0± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0003.0± 2.83
OG0015.0± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0023.0± 2.83
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0003.0± 2.83
OG0015.0± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0023.0± 2.83
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0004.0± 4.24
OG0017.0± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0024.0± 4.24
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0003.0± 2.83
OG0015.0± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0023.0± 2.83
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG0001.0± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0017.0± NAThere were too few participants analyzed at this time point to calculate a standard deviation.
OG0021.0± NAThere were too few participants analyzed at this time point to calculate a standard deviation.