A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects With Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY)
Acronym
Not provided
Organization
EMD SeronoINDUSTRY
Status Module
Record Verification Date
Oct 2020
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
Feb 29, 2008Actual
Primary Completion Date
Dec 31, 2011Actual
Completion Date
Dec 31, 2011Actual
First Submitted Date
Mar 13, 2008
First Submission Date that Met QC Criteria
Mar 21, 2008
First Posted Date
Mar 24, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 30, 2013
Results First Submitted that Met QC Criteria
Sep 30, 2013
Results First Posted Date
Dec 2, 2013Estimated
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
Nov 10, 2020
Last Update Posted Date
Dec 7, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
EMD Serono Research & Development Institute, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The purpose of this extension trial was to further evaluate the safety and tolerability of oral cladribine in subjects who have previously completed treatment within Trial 25643 (CLARITY). This trial also explored clinical benefit of prolonged 192-week versus 96-week treatment.
Detailed Description
Not provided
Conditions Module
Conditions
Relapsing-Remitting Multiple Sclerosis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
867Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cladribine Low/Placebo (LLPP)
Placebo Comparator
Drug: Placebo
Cladribine High Dose/Placebo (HLPP)
Placebo Comparator
Drug: Placebo
Cladribine Low/Low Dose (LLLL)
Experimental
Drug: Cladribine
Cladribine High/Low Dose (HLLL)
Experimental
Drug: Cladribine
Placebo/Cladribine Low Dose (PPLL)
Experimental
Drug: Cladribine
Placebo/No Treatment
No Intervention
Cladribine 3.5 mg/kg/No Treatment
No Intervention
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Cladribine
Drug
Participants who received Cladribine 3.5 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Safety Population: Percentage of Participants With at Least 1 Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 4 Hematologic and Hepatic Toxicity
Hematologic and hepatic toxicity was assessed using Common Terminology Criteria for Adverse Events v 3.0 (CTCAE). Hematologic and hepatic function included absolute lymphocyte count (ALC), hemoglobin level, white blood cell (WBC) count, absolute neutrophil count (ANC), platelets, alanine transaminase (ALT), aspartate transaminase (AST) and bilirubin. According to CTCAE v3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death.
Baseline up to Week 120
Safety Population: Mean Change From Baseline in Absolute Lymphocyte Count, Platelet, Neutrophils and Leukocytes at Week 120
Mean change from baseline in absolute lymphocyte count, platelet, neutrophils and leukocytes at week 120 were reported.
Baseline, Week 120
Safety Population: Mean Change From Baseline in Hemoglobin at Week 120
Mean change from baseline in hemoglobin at Week 120 was reported.
Baseline, Week 120
Safety Population: Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase at Week 120
Mean change from baseline in aspartate aminotransferase and alanine aminotransferase at week 120 were reported.
Baseline, Week 120
Safety Population: Mean Change From Baseline in Bilirubin at Week 120
Mean Change From Baseline in Bilirubin at week 120 was reported.
Baseline, Week 120
Safety Population: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Randomized in Trial 25643 and satisfied one of the following:
Completed randomized treatment course and scheduled visits for the full 96 weeks; or
Did not complete the randomized treatment course in Trial 25643 but elected to receive rescue treatment with Rebif®, another beta-interferon, or glatiramer acetate and completed scheduled clinic visits for the full 96 weeks; or
Did not complete the randomized treatment course in Trial 25643, declined rescue with Rebif®, another beta-interferon, or glatiramer acetate and still completed scheduled clinic visits for the full 96 weeks; or
Did not complete the randomized treatment course in Trial 25643, were not eligible for rescue option with Rebif®, and still completed scheduled clinic visits for the full 96 weeks
Male or female, between 18 and 65 years of age (inclusive, at time of informed consent for Trial 25643)
No medical history or evidence of latent tuberculosis infection (LTBI) or tuberculosis (TB), as evidenced by TB skin test or chest X-ray
All of the following laboratory hematologic parameters evaluated as normal (as define below, inclusively) within 28 days of first dosing of blinded study medication at study Day 1:
Hemoglobin = 11.6 to 16.2 gram per deciliter (g/dL)
Leukocytes (total white blood cell) = 4.1 to 12.3*10^3 per microliter
Absolute lymphocyte count (ALC) = 1.02 to 3.36*10^3 per microliter
Absolute neutrophil count (ANC) = 2.03 to 8.36*10^3 per microliter
Platelet count = 140 to 450*10^3 per microliter
Other protocol-defined inclusion/exclusion criteria may apply
Exclusion Criteria:
Participants who were not enrolled in Trial 25643
Participant has moderate to severe renal impairment
Use of mitoxantrone, total lymphoid irradiation, myelosuppressive therapy, campath-1h, cyclophosphamide, azathioprine, methotrexate or natalizumab at any time during and since Trial 25643
Use of cytokine or anti-cytokine therapy, intravenous immunoglobulin (IVIG) or plasmapheresis at any time during and since Trial 25643
Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone within 28 days before Study Day 1
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Responsible
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Stefano N, Sormani MP, Giovannoni G, Rammohan K, Leist TP, Coyle PK, Dangond F, Alexandri N, Galazka A. Relapses in people with multiple sclerosis treated with cladribine tablets followed for up to 5 years: a plain language summary. Neurodegener Dis Manag. 2022 Dec;12(6):303-310. doi: 10.2217/nmt-2022-0019. Epub 2022 Aug 26.
A total of 1326 subjects were randomized into CLARITY from study 25643 (NCT00213135), of whom 867 consented to participate in this phase 3b extension Study 27820. 806 subjects were randomized or assigned to treatment and a further 61 subjects were followed for safety only (Supplemental follow-up period [no study treatment] [SAFUP]).
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cladribine Low/Placebo (LLPP)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
Cladribine Low/Low Dose (LLLL)
Placebo
Drug
Participants who received Cladribine 3.5 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive placebo matched to cladribine tablet 0.875 mg/kg orally administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 during the treatment period of 96 weeks.
Cladribine Low/Placebo (LLPP)
Cladribine
Drug
Participants who received Cladribine 5.25 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
Cladribine High/Low Dose (HLLL)
Cladribine
Drug
Participants who received placebo in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive cladribine tablet orally as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
Placebo/Cladribine Low Dose (PPLL)
Placebo
Drug
Participants who received Cladribine 5.25 mg/kg in the previous study 25643 (NCT00213135) and completed will be re-randomized in this extension study and receive placebo matched to cladribine tablet 0.875 mg/kg orally administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 during the treatment period of 96 weeks.
Cladribine High Dose/Placebo (HLPP)
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. Serious AE (SAE): Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. Number of participants with TEAEs included participants with both non-serious TEAEs and serious TEAEs.
Baseline up to Week 120
SAFUP Analysis Set: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. Number of participants with TEAEs included participants with both non-serious TEAEs and serious TEAEs.
Baseline up to Week 120
Safety Population: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies
Number of participants who developed Herpes viral infection, Viral infectious disorder and Opportunistic infection are reported. Number of participants with infection related adverse events are the number of participants who had at least one adverse event coded to medical dictionary for regulatory activities (MedDRA) preferred terms under infection and infestation system organ class. Malignancy is defined as having at least one adverse event coded to MedDRA preferred terms under the pre-specified grouping Malignant and unspecified tumors.
Baseline up to Week 120
SAFUP Analysis Set: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies
Number of participants who developed Herpes viral infection, Viral infectious disorder and Opportunistic infection were reported. Number of participants with infection related adverse events are the number of participants who had at least one adverse event coded to medical dictionary for regulatory activities (MedDRA) preferred terms under infection and infestation system organ class. Malignancy is defined as having at least one adverse event coded to MedDRA preferred terms under the pre-specified grouping Malignant and unspecified tumors.
Baseline up to Week 120
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity
Hematologic and hepatic toxicity was assessed using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE). Hematologic and hepatic function included absolute lymphocyte count (ALC), hemoglobin level, white blood cell (WBC) count, absolute neutrophil count (ANC), platelets, alanine transaminase (ALT), aspartate transaminase (AST) and bilirubin. Time to first CTCAE Grade 3 or 4 hematological or liver toxicity was analyzed by treatment group using Kaplan-Meier plots of probability of surviving toxicity-free and point estimates of percentiles. According to CTCAE version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. 10th, 20th, 25th, 50th and 75th percentiles were estimated from Kaplan-Meier survival curve.
Baseline up to Week 120
Safety Population: Median Time to Recovery From Grade 3 or 4 Hematological and Hepatic Toxicity
Hematologic and hepatic toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE). Hematologic and hepatic function included absolute lymphocyte count (ALC), hemoglobin level, white blood cell (WBC) count, absolute neutrophil count (ANC), platelets, alanine transaminase (ALT), aspartate transaminase (AST) and bilirubin. According to CTCAE version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. Time to recovery from grade 3 or 4 hematological or liver toxicity were reported: lymphocytes, platelets, neutrophils, white blood cells, hemoglobin, Alanine transaminase (ALT), Aspartate transaminase (AST), Platelets and Bilirubin. Recovery from a Grade 3 or 4 toxicity is defined as a return to a Grade 0 or 1.
Baseline up to Week 120
Safety Population: Mean Time to Recovery From Grade 3 or 4 Hematological and Liver Toxicity
Hematologic and hepatic toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE). Hematologic and hepatic function included absolute lymphocyte count (ALC), hemoglobin level, white blood cell (WBC) count, absolute neutrophil count (ANC), platelets, alanine transaminase (ALT), aspartate transaminase (AST) and bilirubin. According to CTCAE v3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. Time to recovery from grade 3 or 4 hematological or liver toxicity were reported: lymphocytes, platelets, neutrophils, white blood cells, hemoglobin, Alanine transaminase (ALT), Aspartate transaminase (AST) and Platelets. Recovery from a Grade 3 or 4 toxicity is defined as a return to a Grade 0 or 1.
Baseline up to Week 120
Safety Population: Median Time to Nadir of Absolute Lymphocyte Count
Median time to nadir of absolute lymphocyte count was reported.
Baseline up to Week 120
Safety Population: Mean Time to Nadir of Absolute Lymphocyte Count
Mean time to nadir of absolute lymphocyte count was reported.
Baseline up to Week 120
Safety Population: Mean Time to Recovery From Nadir of Absolute Lymphocyte Count to Normal Value
Mean time to recovery from nadir of absolute lymphocyte count to normal was reported. Recovery from Nadir is defined as a return to baseline value. Normal absolute lymphocyte count is 1.02 x 10^3 cells/microliter.
Baseline up to Week 120
Safety Population: Mean Change in Corrected QT (QTc) Interval From Baseline
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. Mean change in corrected QT (QTc) interval from baseline was reported.
Baseline, Week 5, 48, 52 and 96
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Derived
Giovannoni G, Comi G, Rammohan K, Rieckmann P, Dangond F, Jack D, Vermersch P. Disease stability over five years in people with multiple sclerosis treated with cladribine tablets: a plain language summary. Neurodegener Dis Manag. 2022 Dec;12(6):295-301. doi: 10.2217/nmt-2022-0018. Epub 2022 Aug 26.
Giovannoni G, Comi G, Rammohan K, Rieckmann P, Dangond F, Keller B, Jack D, Vermersch P. Long-Term Disease Stability Assessed by the Expanded Disability Status Scale in Patients Treated with Cladribine Tablets 3.5 mg/kg for Relapsing Multiple Sclerosis: An Exploratory Post Hoc Analysis of the CLARITY and CLARITY Extension Studies. Adv Ther. 2021 Sep;38(9):4975-4985. doi: 10.1007/s12325-021-01865-w. Epub 2021 Aug 9.
De Stefano N, Sormani MP, Giovannoni G, Rammohan K, Leist T, Coyle PK, Dangond F, Keller B, Alexandri N, Galazka A. Analysis of frequency and severity of relapses in multiple sclerosis patients treated with cladribine tablets or placebo: The CLARITY and CLARITY Extension studies. Mult Scler. 2022 Jan;28(1):111-120. doi: 10.1177/13524585211010294. Epub 2021 May 10.
Giovannoni G, Galazka A, Schick R, Leist T, Comi G, Montalban X, Damian D, Dangond F, Cook S. Pregnancy Outcomes During the Clinical Development Program of Cladribine in Multiple Sclerosis: An Integrated Analysis of Safety. Drug Saf. 2020 Jul;43(7):635-643. doi: 10.1007/s40264-020-00948-x.
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
FG002
Cladribine Low/Low Dose (LLLL)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
FG003
Cladribine High/Low Dose (HLLL)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
FG004
Placebo/Cladribine Low Dose (PPLL)
Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
FG005
Placebo/No Treatment
Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
FG006
Cladribine 3.5 mg/kg/No Treatment
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
FG007
Cladribine 5.25 mg/kg/No Treatment
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
FG00098 subjects
FG00192 subjects
FG002186 subjects
FG003186 subjects
FG004244 subjects
FG00522 subjects
FG00617 subjects
FG00722 subjects
COMPLETED
FG00089 subjects
FG00182 subjects
FG002166 subjects
FG003174 subjects
FG004227 subjects
FG00515 subjects
FG00612 subjects
FG00716 subjects
NOT COMPLETED
FG0009 subjects
FG00110 subjects
FG00220 subjects
FG00312 subjects
FG00417 subjects
FG0057 subjects
FG0065 subjects
FG0076 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
FG0042 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Lost to Follow-up
FG0003 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG004
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Death
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Other
FG0004 subjects
FG0017 subjects
FG00214 subjects
FG0039 subjects
FG004
24-Week Supplemental Follow-up Period
Type
Comment
Milestone Data
STARTED
FG00075 subjects
FG00169 subjects
FG002143 subjects
FG003151 subjects
FG004198 subjects
FG00515 subjects
FG0069 subjects
FG00711 subjects
COMPLETED
FG00075 subjects
FG00166 subjects
FG002140 subjects
FG003147 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0013 subjects
FG0023 subjects
FG0034 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG003
Intention-to-treat (ITT) population included all participants who were randomized in the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cladribine Low/Placebo (LLPP)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).
BG001
Cladribine High Dose/Placebo (HLPP)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
BG002
Cladribine Low/Low Dose (LLLL)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
BG003
Cladribine High/Low Dose (HLLL)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
BG004
Placebo/Cladribine Low Dose (PPLL)
Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00098
BG00192
BG002186
BG003186
BG004244
BG005806
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00040.7± 10.7
BG00140.8± 9.6
BG00240.6± 10.5
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00067
BG00159
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
Safety Population: Percentage of Participants With at Least 1 Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 4 Hematologic and Hepatic Toxicity
Hematologic and hepatic toxicity was assessed using Common Terminology Criteria for Adverse Events v 3.0 (CTCAE). Hematologic and hepatic function included absolute lymphocyte count (ALC), hemoglobin level, white blood cell (WBC) count, absolute neutrophil count (ANC), platelets, alanine transaminase (ALT), aspartate transaminase (AST) and bilirubin. According to CTCAE v3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death.
Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data.
Posted
Number
percentage of participants
Baseline up to Week 120
ID
Title
Description
OG000
Cladribine Low/Placebo (LLPP)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).
OG001
Cladribine High Dose/Placebo (HLPP)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG002
Cladribine Low/Low Dose (LLLL)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG003
Cladribine High/Low Dose (HLLL)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG004
Placebo/Cladribine Low Dose (PPLL)
Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Units
Counts
Participants
OG00098
OG00192
OG002186
OG003
Title
Denominators
Categories
Lymphocyte toxicity
Title
Measurements
OG0000.0
OG0010.0
OG0022.7
OG003
Primary
Safety Population: Mean Change From Baseline in Absolute Lymphocyte Count, Platelet, Neutrophils and Leukocytes at Week 120
Mean change from baseline in absolute lymphocyte count, platelet, neutrophils and leukocytes at week 120 were reported.
Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data. Here 'Number of participants analyzed' signifies number of participants who were evaluable for this outcome measure and "Number analyzed" are those who were evaluable at specified category.
Posted
Mean
Standard Deviation
10^9 cells per liter
Baseline, Week 120
ID
Title
Description
OG000
Cladribine Low/Placebo (LLPP)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).
OG001
Cladribine High Dose/Placebo (HLPP)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG002
Primary
Safety Population: Mean Change From Baseline in Hemoglobin at Week 120
Mean change from baseline in hemoglobin at Week 120 was reported.
Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data. Here 'Number of participants analyzed' signifies number of participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
grams per deciliter (g/dL)
Baseline, Week 120
ID
Title
Description
OG000
Cladribine Low/Placebo (LLPP)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).
OG001
Cladribine High Dose/Placebo (HLPP)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG002
Cladribine Low/Low Dose (LLLL)
Primary
Safety Population: Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase at Week 120
Mean change from baseline in aspartate aminotransferase and alanine aminotransferase at week 120 were reported.
Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data. Here 'Number of participants analyzed' signifies number of participants who were evaluable for this outcome measure and "Number analyzed" are those who were evaluable at specified category.
Posted
Mean
Standard Deviation
Units per litre (U/L)
Baseline, Week 120
ID
Title
Description
OG000
Cladribine Low/Placebo (LLPP)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).
OG001
Cladribine High Dose/Placebo (HLPP)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG002
Primary
Safety Population: Mean Change From Baseline in Bilirubin at Week 120
Mean Change From Baseline in Bilirubin at week 120 was reported.
Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data. Here 'Number of participants analyzed' signifies number of participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
micromoles per liter (mcmol/L)
Baseline, Week 120
ID
Title
Description
OG000
Cladribine Low/Placebo (LLPP)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).
OG001
Cladribine High Dose/Placebo (HLPP)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG002
Cladribine Low/Low Dose (LLLL)
Primary
Safety Population: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. Serious AE (SAE): Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. Number of participants with TEAEs included participants with both non-serious TEAEs and serious TEAEs.
Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data.
Posted
Count of Participants
Participants
Baseline up to Week 120
ID
Title
Description
OG000
Cladribine Low/Placebo (LLPP)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).
OG001
Cladribine High Dose/Placebo (HLPP)
Primary
SAFUP Analysis Set: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. Number of participants with TEAEs included participants with both non-serious TEAEs and serious TEAEs.
SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Posted
Count of Participants
Participants
Baseline up to Week 120
ID
Title
Description
OG000
Placebo/No Treatment
Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
OG001
Cladribine 3.5 mg/kg/No Treatment
Primary
Safety Population: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies
Number of participants who developed Herpes viral infection, Viral infectious disorder and Opportunistic infection are reported. Number of participants with infection related adverse events are the number of participants who had at least one adverse event coded to medical dictionary for regulatory activities (MedDRA) preferred terms under infection and infestation system organ class. Malignancy is defined as having at least one adverse event coded to MedDRA preferred terms under the pre-specified grouping Malignant and unspecified tumors.
Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data.
Posted
Count of Participants
Participants
Baseline up to Week 120
ID
Title
Description
OG000
Cladribine Low/Placebo (LLPP)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).
OG001
Cladribine High Dose/Placebo (HLPP)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Primary
SAFUP Analysis Set: Number of Participants Who Developed Infections (Herpes Viral Infection, Viral Infectious Disorder and Opportunistic Infection), Infection-related Adverse Events and Malignancies
Number of participants who developed Herpes viral infection, Viral infectious disorder and Opportunistic infection were reported. Number of participants with infection related adverse events are the number of participants who had at least one adverse event coded to medical dictionary for regulatory activities (MedDRA) preferred terms under infection and infestation system organ class. Malignancy is defined as having at least one adverse event coded to MedDRA preferred terms under the pre-specified grouping Malignant and unspecified tumors.
SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
Posted
Count of Participants
Participants
Baseline up to Week 120
ID
Title
Description
OG000
Placebo/No Treatment
Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
OG001
Cladribine 3.5 mg/kg/No Treatment
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
Primary
Safety Population: Time to First Grade 3 or 4 Hematological Toxicity and Liver Toxicity
Hematologic and hepatic toxicity was assessed using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE). Hematologic and hepatic function included absolute lymphocyte count (ALC), hemoglobin level, white blood cell (WBC) count, absolute neutrophil count (ANC), platelets, alanine transaminase (ALT), aspartate transaminase (AST) and bilirubin. Time to first CTCAE Grade 3 or 4 hematological or liver toxicity was analyzed by treatment group using Kaplan-Meier plots of probability of surviving toxicity-free and point estimates of percentiles. According to CTCAE version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. 10th, 20th, 25th, 50th and 75th percentiles were estimated from Kaplan-Meier survival curve.
Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. Here 'Number of participants analyzed' signifies number of participants who were evaluable for this outcome measure and "Number Analyzed"signifies those participants who were evaluable for specified category.
Posted
Number
95% Confidence Interval
Days
Baseline up to Week 120
ID
Title
Description
OG000
Cladribine Low/Placebo (LLPP)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).
Primary
Safety Population: Median Time to Recovery From Grade 3 or 4 Hematological and Hepatic Toxicity
Hematologic and hepatic toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE). Hematologic and hepatic function included absolute lymphocyte count (ALC), hemoglobin level, white blood cell (WBC) count, absolute neutrophil count (ANC), platelets, alanine transaminase (ALT), aspartate transaminase (AST) and bilirubin. According to CTCAE version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. Time to recovery from grade 3 or 4 hematological or liver toxicity were reported: lymphocytes, platelets, neutrophils, white blood cells, hemoglobin, Alanine transaminase (ALT), Aspartate transaminase (AST), Platelets and Bilirubin. Recovery from a Grade 3 or 4 toxicity is defined as a return to a Grade 0 or 1.
Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. Here 'Number of participants analyzed' signifies number of participants who were evaluable for this outcome measure and "Number Analyzed signifies those participants who were evaluable for specified category.
Posted
Median
Full Range
Days
Baseline up to Week 120
ID
Title
Description
OG000
Cladribine Low/Placebo (LLPP)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).
Primary
Safety Population: Mean Time to Recovery From Grade 3 or 4 Hematological and Liver Toxicity
Hematologic and hepatic toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE). Hematologic and hepatic function included absolute lymphocyte count (ALC), hemoglobin level, white blood cell (WBC) count, absolute neutrophil count (ANC), platelets, alanine transaminase (ALT), aspartate transaminase (AST) and bilirubin. According to CTCAE v3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death. Time to recovery from grade 3 or 4 hematological or liver toxicity were reported: lymphocytes, platelets, neutrophils, white blood cells, hemoglobin, Alanine transaminase (ALT), Aspartate transaminase (AST) and Platelets. Recovery from a Grade 3 or 4 toxicity is defined as a return to a Grade 0 or 1.
Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data. Here 'Number of participants analyzed' signifies number of participants who were evaluable for this outcome measure and "Number analyzed" are those who were evaluable at specified category.
Posted
Mean
Standard Deviation
Days
Baseline up to Week 120
ID
Title
Description
OG000
Cladribine Low/Placebo (LLPP)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).
Primary
Safety Population: Median Time to Nadir of Absolute Lymphocyte Count
Median time to nadir of absolute lymphocyte count was reported.
Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data. Here 'Number of participants analyzed' signifies number of participants who were evaluable for this outcome measure.
Posted
Median
97.5% Confidence Interval
Days
Baseline up to Week 120
ID
Title
Description
OG000
Cladribine Low/Placebo (LLPP)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).
OG001
Cladribine High Dose/Placebo (HLPP)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG002
Cladribine Low/Low Dose (LLLL)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Primary
Safety Population: Mean Time to Nadir of Absolute Lymphocyte Count
Mean time to nadir of absolute lymphocyte count was reported.
Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data. Here 'Number of participants analyzed' signifies number of participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Days
Baseline up to Week 120
ID
Title
Description
OG000
Cladribine Low/Placebo (LLPP)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).
OG001
Cladribine High Dose/Placebo (HLPP)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG002
Cladribine Low/Low Dose (LLLL)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Primary
Safety Population: Mean Time to Recovery From Nadir of Absolute Lymphocyte Count to Normal Value
Mean time to recovery from nadir of absolute lymphocyte count to normal was reported. Recovery from Nadir is defined as a return to baseline value. Normal absolute lymphocyte count is 1.02 x 10^3 cells/microliter.
Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data. Here 'Number of participants analyzed' signifies number of participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Days
Baseline up to Week 120
ID
Title
Description
OG000
Cladribine Low/Placebo (LLPP)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).
OG001
Cladribine High Dose/Placebo (HLPP)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG002
Primary
Safety Population: Mean Change in Corrected QT (QTc) Interval From Baseline
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. Mean change in corrected QT (QTc) interval from baseline was reported.
Safety population included all the randomized participants who had received at least 1 dose of study medication and had follow-up safety data. Here 'Number of participants analyzed' signifies number of participants who were evaluable for this outcome measure and and "Number analyzed" are those who were evaluable at specified category.
Posted
Mean
Standard Deviation
milliseconds
Baseline, Week 5, 48, 52 and 96
ID
Title
Description
OG000
Cladribine Low/Placebo (LLPP)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).
OG001
Cladribine High Dose/Placebo (HLPP)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Time Frame
Baseline up to Week 120
Description
For LLPP, HLPP, LLLL, HLLL and PPLL arms: Safety population included all the randomized participants who had received at least 1dose of study medication and had follow-up safety data. For Placebo/No treatment, Cladribine 3.5 mg/kg/No Treatment and Cladribine 5.25 mg/kg/No Treatment: SAFUP Analysis Set included all participants who were enrolled and had at least one safety assessment, but were not randomized or assigned to treatment because they were not eligible to receive study medication.
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
Cladribine Low/Placebo (LLPP)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in Supplemental follow-up period (SUPF).
2
98
16
98
73
98
EG001
Cladribine High Dose/Placebo (HLPP)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
0
92
8
92
69
92
EG002
Cladribine Low/Low Dose (LLLL)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
1
186
25
186
143
186
EG003
Cladribine High/Low Dose (HLLL)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
0
186
23
186
146
186
EG004
Placebo/Cladribine Low Dose (PPLL)
Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
0
244
22
244
192
244
EG005
Placebo/No Treatment
Participants who received placebo matched to cladribine in previous study 25643 (NCT00213135) and were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
0
22
2
22
16
22
EG006
Cladribine 3.5 mg/kg/No Treatment
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
0
17
1
17
13
17
EG007
Cladribine 5.25 mg/kg/No Treatment
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
0
22
3
22
18
22
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0022 affected186 at risk
EG0032 affected186 at risk
EG004
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0012 affected92 at risk
EG0020 affected186 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Adrenal adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Bile duct cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Breast fibroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Colorectal cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Fibrous histiocytoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Haemangioma of liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Juvenile melanoma benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Lung neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Metastases to lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Metastases to lymph nodes
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Neurilemmoma benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Prostatic adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Thyroid adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0011 affected92 at risk
EG0020 affected186 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Abscess oral
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Bacterial sepsis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Breast abscess
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Infection
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Influenza
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0011 affected92 at risk
EG0020 affected186 at risk
EG003
Pyelonephritis chronic
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0011 affected92 at risk
EG0020 affected186 at risk
EG003
Urethral abscess
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Duodenal ulcer perforation
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0011 affected92 at risk
EG0020 affected186 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Ileus paralytic
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Peritonitis
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Intentional overdose
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Ovarian cyst ruptured
Reproductive system and breast disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Adams-Stokes syndrome
Cardiac disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Chest pain
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Death
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Drowning
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Influenza like illness
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0010 affected92 at risk
EG0022 affected186 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Biliary tract disorder
Hepatobiliary disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Blood culture positive
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Pregnancy test positive
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Tuberculin test positive
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Weight decreased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Brain injury
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Cauda equina syndrome
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Radicular syndrome
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Sciatica
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Status epilepticus
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Bronchitis chronic
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Mental disorder
Psychiatric disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Basedow's disease
Endocrine disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Thyroiditis
Endocrine disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Iridocyclitis
Eye disorders
MedDRA (11.0)
Non-systematic Assessment
EG0002 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Macular degeneration
Eye disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0011 affected92 at risk
EG0020 affected186 at risk
EG003
Cystitis noninfective
Renal and urinary disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Renal failure chronic
Renal and urinary disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Varicose vein
Vascular disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0011 affected92 at risk
EG0020 affected186 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Secondary immunodeficiency
Immune system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Abortion missed
Pregnancy, puerperium and perinatal conditions
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Abortion induced
Surgical and medical procedures
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Autoimmune thyroiditis
Endocrine disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Abortion threatened
Pregnancy, puerperium and perinatal conditions
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Ovarian cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0021 affected186 at risk
EG003
Venous Stasis
Vascular disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Cervix Carcinoma Stage 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Acarodermatitis
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphopenia
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0009 affected98 at risk
EG0017 affected92 at risk
EG00268 affected186 at risk
EG00375 affected186 at risk
EG00469 affected244 at risk
EG0052 affected22 at risk
EG0062 affected17 at risk
EG0075 affected22 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0012 affected92 at risk
EG00219 affected186 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0002 affected98 at risk
EG0012 affected92 at risk
EG0027 affected186 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (11.0)
Non-systematic Assessment
EG0005 affected98 at risk
EG0011 affected92 at risk
EG0026 affected186 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0007 affected98 at risk
EG0016 affected92 at risk
EG0026 affected186 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0008 affected98 at risk
EG0014 affected92 at risk
EG00211 affected186 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0004 affected98 at risk
EG0016 affected92 at risk
EG0025 affected186 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 affected98 at risk
EG0015 affected92 at risk
EG0025 affected186 at risk
EG003
Fatigue
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0005 affected98 at risk
EG0015 affected92 at risk
EG0028 affected186 at risk
EG003
Influenza like illness
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0005 affected98 at risk
EG0012 affected92 at risk
EG00214 affected186 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG00019 affected98 at risk
EG00115 affected92 at risk
EG00222 affected186 at risk
EG003
Influenza
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG00011 affected98 at risk
EG00110 affected92 at risk
EG00215 affected186 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0008 affected98 at risk
EG0019 affected92 at risk
EG00217 affected186 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0006 affected98 at risk
EG0014 affected92 at risk
EG00217 affected186 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0009 affected98 at risk
EG0019 affected92 at risk
EG00216 affected186 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0008 affected98 at risk
EG0016 affected92 at risk
EG00210 affected186 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0005 affected98 at risk
EG0014 affected92 at risk
EG0025 affected186 at risk
EG003
Headache
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG00020 affected98 at risk
EG00116 affected92 at risk
EG00221 affected186 at risk
EG003
Depression
Psychiatric disorders
MedDRA (11.0)
Non-systematic Assessment
EG0006 affected98 at risk
EG0011 affected92 at risk
EG0026 affected186 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (11.0)
Non-systematic Assessment
EG0005 affected98 at risk
EG0012 affected92 at risk
EG0024 affected186 at risk
EG003
Hypertension
Vascular disorders
MedDRA (11.0)
Non-systematic Assessment
EG0004 affected98 at risk
EG0015 affected92 at risk
EG0025 affected186 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0006 affected98 at risk
EG0017 affected92 at risk
EG0021 affected186 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Anaemia of pregnancy
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Eye irritation
Eye disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Eye pruritus
Eye disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Tooth disorder
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Faecal incontinence
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Asthenia
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Hyperthermia
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Viral infection
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Erythema infectiosum
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Infected insect bite
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Injection site abscess
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Skin bacterial infection
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Red blood cell burr cells present
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Liver function test abnormal
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Weight decreased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Sensation of heaviness
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Syncope
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Abscess Limb
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Acute Tonsillitis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Anisocytosis
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Aphthous Stomatitis
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Blood Potassium Decreased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Blood Thyroid Stimulating Hormone Increased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Blood Urea Increased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Blood Urine Present
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Bone Cyst
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Breast Discharge
Reproductive system and breast disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Breath Sounds Abnormal
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Bundle Branch Block Left
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Cervical Dysplasia
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Chest Pain
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Eosinophil Count Decreased
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Eosinophil Count Increased
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Excoriation
Psychiatric disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Facial Pain
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Foot Fracture
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Furuncle
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Gastroenteritis
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Gingivitis
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Haemoglobin Decreased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Haemorrhoids
Metabolism and nutrition disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Hemicephalalgia
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Hordeolum
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Hot Flush
Vascular disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Hyperbilirubinaemia
Congenital, familial and genetic disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Ingrowing Nail
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Injection Site Erythema
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Injection Site Extravasation
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Injection Site Inflammation
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Injection Site Pain
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Local Swelling
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Lower Respiratory Tract Infection
Immune system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Lymphocytosis
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Macrocytosis
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Monocyte Count Decreased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Mouth Ulceration
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Musculoskeletal Disorder
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Oedema Peripheral
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Oral Candidiasis
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Oral Herpes
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Pancreatic Cyst
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Paronychia
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Patellofemoral Pain Syndrome
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Poikilocytosis
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Productive Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Protein Urine Present
Renal and urinary disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Pyrexia
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Red Blood Cell Abnormality
Blood and lymphatic system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Red Blood Cell Morphology Abnormal
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Retinal Tear
Eye disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Smear Cervix Abnormal
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Tendonitis
Injury, poisoning and procedural complications
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Tension Headache
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Thyroid Function Test Abnormal
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Tonsillitis
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Tooth Abscess
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Tooth Infection
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Tremor
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Urinary Tract Infection Bacterial
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Vertigo Positional
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
Weight Increased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 at risk
EG003
White Blood Cell Count Increased
Investigations
MedDRA (11.0)
Non-systematic Assessment
EG0000 affected98 at risk
EG0010 affected92 at risk
EG0020 affected186 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
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Communication Center
Merck KGaA, Darmstadt, Germany
+49-6151-72-5200
service@emdgroup.com
ID
Term
D020529
Multiple Sclerosis, Relapsing-Remitting
Ancestor Terms
ID
Term
D009103
Multiple Sclerosis
D020278
Demyelinating Autoimmune Diseases, CNS
D020274
Autoimmune Diseases of the Nervous System
D009422
Nervous System Diseases
D003711
Demyelinating Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D017338
Cladribine
Ancestor Terms
ID
Term
D015762
2-Chloroadenosine
D000241
Adenosine
D011684
Purine Nucleosides
D011687
Purines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
D003839
Deoxyadenosines
D003853
Deoxyribonucleosides
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
D012263
Ribonucleosides
Browse Leaves
Not provided
Browse Branches
Not provided
4 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
11 subjects
FG0056 subjects
FG0064 subjects
FG0076 subjects
193 subjects
FG00514 subjects
FG0068 subjects
FG00710 subjects
5 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
3 subjects
FG0042 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
Other
FG0000 subjects
FG0012 subjects
FG0022 subjects
FG0031 subjects
FG0043 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
41.4
± 10.1
BG00441.6± 9.6
BG00541.1± 10.1
124
BG003125
BG004156
BG005531
Male
BG00031
BG00133
BG00262
BG00361
BG00488
BG005275
186
OG004244
3.2
OG0040.4
Hemoglobin Toxicity
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG0030.0
OG0040.0
White Blood Cell Toxicity
Title
Measurements
OG0000.0
OG0010.0
OG0020.5
OG0030.0
OG0040.0
Absolute Neutrophil Count Toxicity
Title
Measurements
OG0000.0
OG0012.2
OG0020.5
OG0030.0
OG0040.4
Platelets Toxicity
Title
Measurements
OG0000.0
OG0010.0
OG0020.5
OG0030.0
OG0040.0
Alanine Transaminase Toxicity
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG0030.0
OG0040.0
AsparateTransaminase Toxicity
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG0030.0
OG0040.0
Bilirubin Toxicity
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG0030.0
OG0040.0
Cladribine Low/Low Dose (LLLL)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG003
Cladribine High/Low Dose (HLLL)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG004
Placebo/Cladribine Low Dose (PPLL)
Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Units
Counts
Participants
OG00073
OG00162
OG002137
OG003144
OG004187
Title
Denominators
Categories
Lymphocyte Count
ParticipantsOG00073
ParticipantsOG00162
ParticipantsOG002137
ParticipantsOG003142
ParticipantsOG004187
Title
Measurements
OG0000.3± 0.4
OG0010.3± 0.4
OG0020.0± 0.4
OG003
Platelet
ParticipantsOG00073
ParticipantsOG00162
ParticipantsOG002136
ParticipantsOG003143
Leukocytes
ParticipantsOG00073
ParticipantsOG00162
ParticipantsOG002136
ParticipantsOG003144
Neutrophils
ParticipantsOG00073
ParticipantsOG00162
ParticipantsOG002137
ParticipantsOG003142
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG003
Cladribine High/Low Dose (HLLL)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG004
Placebo/Cladribine Low Dose (PPLL)
Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Units
Counts
Participants
OG00073
OG00162
OG002137
OG003144
OG004187
Title
Denominators
Categories
Title
Measurements
OG0000.2± 0.9
OG0010.2± 0.7
OG002-0.1± 0.9
OG0030.1± 0.9
OG004-0.1± 0.9
Cladribine Low/Low Dose (LLLL)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG003
Cladribine High/Low Dose (HLLL)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG004
Placebo/Cladribine Low Dose (PPLL)
Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Units
Counts
Participants
OG00072
OG00162
OG002137
OG003142
OG004185
Title
Denominators
Categories
Aspartate Aminotransferase
ParticipantsOG00072
ParticipantsOG00162
ParticipantsOG002137
ParticipantsOG003142
ParticipantsOG004184
Title
Measurements
OG0000.7± 10.6
OG001-1.1± 6.4
OG0022.2± 7.3
OG003
Alanine Aminotransferase
ParticipantsOG00072
ParticipantsOG00162
ParticipantsOG002137
ParticipantsOG003142
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG003
Cladribine High/Low Dose (HLLL)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG004
Placebo/Cladribine Low Dose (PPLL)
Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Units
Counts
Participants
OG00073
OG00162
OG002137
OG003144
OG004186
Title
Denominators
Categories
Title
Measurements
OG0000.1± 3.7
OG0010.0± 3.5
OG002-0.8± 3.7
OG003-0.8± 3.3
OG004-0.4± 3.7
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG002
Cladribine Low/Low Dose (LLLL)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG003
Cladribine High/Low Dose (HLLL)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG004
Placebo/Cladribine Low Dose (PPLL)
Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Units
Counts
Participants
OG00098
OG00192
OG002186
OG003186
OG004244
Title
Denominators
Categories
TEAEs
Title
Measurements
OG00074
OG00171
OG002149
OG003149
OG004194
Serious TEAEs
Title
Measurements
OG00016
OG0018
OG00225
OG003
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
OG002
Cladribine 5.25 mg/kg/No Treatment
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
Units
Counts
Participants
OG00022
OG00117
OG00222
Title
Denominators
Categories
TEAEs
Title
Measurements
OG00016
OG00113
OG00218
Serious TEAEs
Title
Measurements
OG0002
OG0011
OG0023
OG002
Cladribine Low/Low Dose (LLLL)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG003
Cladribine High/Low Dose (HLLL)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG004
Placebo/Cladribine Low Dose (PPLL)
Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Units
Counts
Participants
OG00098
OG00192
OG002186
OG003186
OG004244
Title
Denominators
Categories
Herpes viral infection
Title
Measurements
OG0006
OG0014
OG0026
OG00313
OG00411
Opportunistic infection
Title
Measurements
OG0008
OG0014
OG0029
OG003
Viral infectious disorder
Title
Measurements
OG00020
OG00116
OG00228
OG003
Infections related adverse event
Title
Measurements
OG00049
OG00145
OG00292
OG003
Malignancies
Title
Measurements
OG0002
OG0011
OG0027
OG003
OG002
Cladribine 5.25 mg/kg/No Treatment
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed were enrolled in this extension study and received no cladribine treatment and were followed up for safety assessment for 96 weeks (during the treatment period) and followed up for 24 weeks (during supplemental follow-up period).
Units
Counts
Participants
OG00022
OG00117
OG00222
Title
Denominators
Categories
Herpes viral infection
Title
Measurements
OG0000
OG0011
OG0021
Opportunistic infection
Title
Measurements
OG0000
OG0011
OG0022
Viral infectious disorder
Title
Measurements
OG0006
OG0015
OG0023
Infections related adverse event
Title
Measurements
OG00011
OG0016
OG00212
Malignancies
Title
Measurements
OG0002
OG0010
OG0021
OG001
Cladribine High Dose/Placebo (HLPP)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG002
Cladribine Low/Low Dose (LLLL)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG003
Cladribine High/Low Dose (HLLL)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG004
Placebo/Cladribine Low Dose (PPLL)
Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Units
Counts
Participants
OG0005
OG0016
OG00276
OG00399
OG00461
Title
Denominators
Categories
10th percentile: Lymphocytes Count
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG00276
ParticipantsOG00399
ParticipantsOG00461
Title
Measurements
OG000NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG001NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG00214(8 to 34)
OG003
20th percentile: Lymphocytes Count
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG00276
ParticipantsOG00399
25th percentile: Lymphocytes Count
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG00276
ParticipantsOG00399
50th percentile: Lymphocytes Count
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG00276
ParticipantsOG00399
75th percentile: Lymphocytes Count
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG00276
ParticipantsOG00399
10th percentile: Hemoglobin
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0031
20th percentile: Hemoglobin
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0031
25th percentile: Hemoglobin
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0031
50th percentile: Hemoglobin
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0031
75th percentile: Hemoglobin
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG0031
10th percentile: WBC
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG00211
ParticipantsOG00311
20th percentile: WBC
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG00211
ParticipantsOG00311
25th percentile: WBC
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG00211
ParticipantsOG00311
50th percentile: WBC
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG00211
ParticipantsOG00311
75th percentile: WBC
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG00211
ParticipantsOG00311
10th percentile: ANC
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG00312
20th percentile: ANC
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG00312
25th percentile: ANC
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG00312
50th percentile: ANC
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG00312
75th percentile: ANC
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG00312
10th percentile: Platelets
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
20th percentile: Platelets
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
25th percentile: Platelets
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
50th percentile: Platelets
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
75th percentile: Platelets
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
10th percentile: ALT
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0033
20th percentile: ALT
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0033
25th percentile: ALT
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0033
50th percentile: ALT
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0033
75th percentile: ALT
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0033
10th percentile: AST
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
20th percentile: AST
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
25th percentile: AST
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
50th percentile: AST
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
75th percentile: AST
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
10th percentile: Bilirubin
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
20th percentile: Bilirubin
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
25th percentile: Bilirubin
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
50th percentile: Bilirubin
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
75th percentile: Bilirubin
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG001
Cladribine High Dose/Placebo (HLPP)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG002
Cladribine Low/Low Dose (LLLL)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG003
Cladribine High/Low Dose (HLLL)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG004
Placebo/Cladribine Low Dose (PPLL)
Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Units
Counts
Participants
OG0005
OG0014
OG00269
OG00389
OG00450
Title
Denominators
Categories
Lymphocyte
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG00269
ParticipantsOG00389
ParticipantsOG00450
Title
Measurements
OG00022.0(14 to 85)
OG00131.5(26 to 51)
OG002212.0(8 to 1184)
OG003
Hemoglobin
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0031
White Blood Cell Count
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0029
ParticipantsOG00310
Absolute Neutrophil Count
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG00311
Platelets
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Alanine Transaminase (ALT)
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
Aspartate Transaminase (AST)
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
Bilirubin
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG001
Cladribine High Dose/Placebo (HLPP)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to placebo (matched to cladribine tablet) during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG002
Cladribine Low/Low Dose (LLLL)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG003
Cladribine High/Low Dose (HLLL)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG004
Placebo/Cladribine Low Dose (PPLL)
Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Units
Counts
Participants
OG0005
OG0014
OG00269
OG00389
OG00450
Title
Denominators
Categories
Lymphocyte
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG00269
ParticipantsOG00389
ParticipantsOG00450
Title
Measurements
OG00041.0± 33.5
OG00134.9± 11.7
OG002256.7± 239.7
OG003
Hemoglobin
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0031
White Blood Cell Count
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0029
ParticipantsOG00310
Absolute Neutrophil Count
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG00311
Platelets
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Alanine Transaminase
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0032
Aspartate Transaminase
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
Bilirubin
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG003
Cladribine High/Low Dose (HLLL)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG004
Placebo/Cladribine Low Dose (PPLL)
Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Units
Counts
Participants
OG00054
OG00157
OG002177
OG003175
OG004227
Title
Denominators
Categories
Title
Measurements
OG000162.0(86 to 372)
OG00193.0(37 to 252)
OG002365.0(246 to 379)
OG003162.0(106 to 359)
OG004380.0(379 to 400)
OG003
Cladribine High/Low Dose (HLLL)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG004
Placebo/Cladribine Low Dose (PPLL)
Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Units
Counts
Participants
OG00054
OG00157
OG002177
OG003175
OG004227
Title
Denominators
Categories
Title
Measurements
OG000292.0± 296.7
OG001193.6± 219.1
OG002276.7± 191.7
OG003241.1± 200.3
OG004362.9± 177.5
Cladribine Low/Low Dose (LLLL)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG003
Cladribine High/Low Dose (HLLL)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG004
Placebo/Cladribine Low Dose (PPLL)
Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Units
Counts
Participants
OG00047
OG00152
OG002130
OG003128
OG004185
Title
Denominators
Categories
Title
Measurements
OG00079.0± 72.4
OG00172.7± 61.3
OG002237.5± 214.7
OG003245.3± 222.3
OG004187.8± 180.9
OG002
Cladribine Low/Low Dose (LLLL)
Participants who received cladribine 3.5 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG003
Cladribine High/Low Dose (HLLL)
Participants who received cladribine 5.25 mg/kg in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
OG004
Placebo/Cladribine Low Dose (PPLL)
Participants who received placebo in previous study 25643 (NCT00213135) and completed the study who were randomized or assigned to cladribine 3.5 mg/kg orally provided as 0.875 mg/kg treatment weeks at Week 1, Week 5, Week 48 and Week 52 resulting in total dose of 3.5 mg/kg during the treatment period of 96 weeks. Participants were followed up for 24 weeks in SUPF.
Units
Counts
Participants
OG00025
OG00118
OG00231
OG00335
OG00441
Title
Denominators
Categories
Week 5
ParticipantsOG00025
ParticipantsOG00118
ParticipantsOG00231
ParticipantsOG00335
ParticipantsOG00441
Title
Measurements
OG0007.0± 21.6
OG0017.4± 21.2
OG0024.5± 20.6
OG003
Week 48
ParticipantsOG00019
ParticipantsOG00115
ParticipantsOG00223
ParticipantsOG00333
Week 52
ParticipantsOG0007
ParticipantsOG0013
ParticipantsOG0027
ParticipantsOG00310
Week 96
ParticipantsOG00019
ParticipantsOG0019
ParticipantsOG00224
ParticipantsOG00331
0 affected
244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
2 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0043 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0042 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0041 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
1 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
20 affected
186 at risk
EG00412 affected244 at risk
EG0052 affected22 at risk
EG0060 affected17 at risk
EG0073 affected22 at risk
10 affected
186 at risk
EG0047 affected244 at risk
EG0051 affected22 at risk
EG0061 affected5 at risk
EG0075 affected22 at risk
5 affected
186 at risk
EG0045 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
9 affected
186 at risk
EG00414 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
7 affected
186 at risk
EG00410 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0072 affected22 at risk
3 affected
186 at risk
EG0044 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0073 affected22 at risk
0 affected
186 at risk
EG0044 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
10 affected
186 at risk
EG00412 affected244 at risk
EG0051 affected22 at risk
EG0062 affected17 at risk
EG0071 affected22 at risk
9 affected
186 at risk
EG00410 affected244 at risk
EG0051 affected22 at risk
EG0062 affected17 at risk
EG0072 affected22 at risk
28 affected
186 at risk
EG00445 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0076 affected22 at risk
23 affected
186 at risk
EG00417 affected244 at risk
EG0054 affected22 at risk
EG0062 affected17 at risk
EG0072 affected22 at risk
20 affected
186 at risk
EG00419 affected244 at risk
EG0051 affected22 at risk
EG0061 affected17 at risk
EG0072 affected22 at risk
16 affected
186 at risk
EG00416 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
18 affected
186 at risk
EG00428 affected244 at risk
EG0051 affected22 at risk
EG0064 affected17 at risk
EG0072 affected22 at risk
10 affected
186 at risk
EG00411 affected244 at risk
EG0052 affected22 at risk
EG0061 affected17 at risk
EG0071 affected22 at risk
8 affected
186 at risk
EG00413 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0073 affected22 at risk
25 affected
186 at risk
EG00438 affected244 at risk
EG0053 affected22 at risk
EG0061 affected17 at risk
EG0074 affected22 at risk
5 affected
186 at risk
EG0049 affected244 at risk
EG0051 affected22 at risk
EG0061 affected17 at risk
EG0071 affected22 at risk
5 affected
186 at risk
EG0047 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0072 affected22 at risk
2 affected
186 at risk
EG0047 affected244 at risk
EG0051 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
12 affected
186 at risk
EG00417 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0052 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0072 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0052 affected22 at risk
EG0060 affected17 at risk
EG0072 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0062 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0052 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0072 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0072 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0052 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0072 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0072 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0052 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0061 affected17 at risk
EG0072 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0072 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0061 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0051 affected22 at risk
EG0060 affected17 at risk
EG0070 affected22 at risk
0 affected
186 at risk
EG0040 affected244 at risk
EG0050 affected22 at risk
EG0060 affected17 at risk
EG0071 affected22 at risk
0.0
± 0.5
OG004-0.6± 0.6
Participants
OG004
187
Title
Measurements
OG000-7.7± 26.2
OG001-11.9± 35.3
OG002-20.6± 37.9
OG003-9.7± 51.2
OG004-34.0± 37.2
Participants
OG004
187
Title
Measurements
OG0000.8± 1.5
OG0010.5± 1.2
OG002-0.2± 1.5
OG003-0.1± 1.4
OG004-0.9± 1.7
ParticipantsOG004187
Title
Measurements
OG0000.4± 1.3
OG0010.1± 1.2
OG002-0.2± 1.4
OG003-0.2± 1.3
OG004-0.3± 1.7
0.7
± 11.3
OG0040.5± 5.1
ParticipantsOG004185
Title
Measurements
OG0002.2± 26.0
OG001-1.0± 11.7
OG0024.3± 14.3
OG0030.7± 17.5
OG0041.4± 12.2
23
OG00422
17
OG00415
41
OG00439
88
OG004112
2
OG0042
8
(8 to 12)
OG004362(85 to 378)
ParticipantsOG00461
Title
Measurements
OG000NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG001NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG00258(34 to 162)
OG00315(12 to 50)
OG004412(379 to 583)
ParticipantsOG00461
Title
Measurements
OG000NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG001NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002108(57 to 379)
OG00334(15 to 57)
OG004583(406 to NA)Due to higher percentiles not attained, upper limit of 95% Confidence Interval from the Kaplan-Meier survival curves could not be derived.
ParticipantsOG00461
Title
Measurements
OG000NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG001NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003449(361 to NA)Due to higher percentiles not attained, upper limit of 95% Confidence Interval from the Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG00461
Title
Measurements
OG000NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG001NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0043
Title
Measurements
OG001NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0043
Title
Measurements
OG001NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0043
Title
Measurements
OG001NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0043
Title
Measurements
OG001NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0043
Title
Measurements
OG001NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0045
Title
Measurements
OG001NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0045
Title
Measurements
OG001NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0045
Title
Measurements
OG001NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0045
Title
Measurements
OG001NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0045
Title
Measurements
OG001NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0048
Title
Measurements
OG000NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG001NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0048
Title
Measurements
OG000NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG001NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0048
Title
Measurements
OG000NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG001NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0048
Title
Measurements
OG000NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG001NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0048
Title
Measurements
OG000NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG001NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0040
Title
Measurements
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0040
Title
Measurements
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0040
Title
Measurements
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0040
Title
Measurements
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0040
Title
Measurements
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0043
Title
Measurements
OG000NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0043
Title
Measurements
OG000NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0043
Title
Measurements
OG000NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0043
Title
Measurements
OG000NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0043
Title
Measurements
OG000NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0041
Title
Measurements
OG000NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0041
Title
Measurements
OG000NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0041
Title
Measurements
OG000NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0041
Title
Measurements
OG000NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
ParticipantsOG0041
Title
Measurements
OG000NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG002NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG003NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.
OG004NA(NA to NA)Due to small number of events, estimates from Kaplan-Meier survival curves could not be derived.