Efficacy of 400 Mg Versus 800 Mg Imatinib in Chronic Myel... | NCT00124748

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Imatinib 400 mg	Experimental	Oral dose of 400mg Imatinib once daily. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.	Drug: Imatinib mesylate
imatinib 800 mg	Experimental	Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.	Drug: Imatinib mesylate

Name	Type	Description	Arm Group Labels	Other Names
Imatinib mesylate	Drug	Imatinib is packaged in bottles as 100mg and 400mg tablets	Imatinib 400 mg imatinib 800 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Major Molecular Response (MMR) Rates at 12 Months	MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally).	12 months

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Major Molecular Response (MMR) Rates at 24, 36, and 42 Months	MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients within 6 months of diagnosis (date of initial diagnosis is the date of first cytogenetic analysis)
Diagnosis of chronic myelogenous leukemia (CML) in chronic phase with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations and presence of Breakpoint cluster region gene-abelson proto-oncogene (Bcr-Abl)
Documented chronic phase CML
Adequate end organ function as defined by:
- total bilirubin < 1.5 x Upper Limit of Normal (ULN)
- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) < 2.5 x ULN
- creatinine < 1.5 x ULN

Exclusion Criteria:

Patients in late chronic phase, accelerated phase, or blastic phase are excluded
Patients who have received other investigational agents
Patients who received Gleevec/Glivec for any duration prior to study entry, with the exception of those patients successfully completing [CSTI571A2107 (NCT00428909)] study immediately prior to the participation in this study
Patient received any treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide
Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention
Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to baseline and (d) male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
Patient with a severe or uncontrolled medical condition (i.e., uncontrolled diabetes,chronic renal disease)
Patient previously received radiotherapy to ≥ 25% of the bone marrow
Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery
Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status Score ≥ 3
Patients with International normalized ratio (INR) or partial thromboplastin time (PTT) > 1.5 x ULN, with the exception of patients on treatment with oral anticoagulants
Patients with known positivity for human immunodeficiency virus (HIV); baseline testing for HIV is not required
Patients with identified sibling donors where allogeneic bone marrow transplant is elected as first line treatment

Other protocol-defined inclusion/exclusion criteria applied.

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of South Alabama		Mobile	Alabama	36693	United States
Alta Bates Comprehsenive Cancer Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24859364	Derived	Branford S, Yeung DT, Parker WT, Roberts ND, Purins L, Braley JA, Altamura HK, Yeoman AL, Georgievski J, Jamison BA, Phillis S, Donaldson Z, Leong M, Fletcher L, Seymour JF, Grigg AP, Ross DM, Hughes TP. Prognosis for patients with CML and >10% BCR-ABL1 after 3 months of imatinib depends on the rate of BCR-ABL1 decline. Blood. 2014 Jul 24;124(4):511-8. doi: 10.1182/blood-2014-03-566323. Epub 2014 May 23.
23515925

Label	URL
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Imatinib 400 mg	Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
FG001	Imatinib 800 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Imatinib 400 mg	Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
BG001	Imatinib 800 mg	Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
BG002	Total	Total of all reporting groups

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

Percentage of Participants With Major Molecular Response (MMR) Rates at 12 Months

MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally).

Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.

Posted

Number

Percentage of participants

12 months

ID	Title	Description
OG000	Imatinib 400 mg	Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
OG001	Imatinib 800 mg	Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.

Units	Counts
Participants	OG000157 OG001319

Title

Denominators

Categories

Title	Measurements
	OG00038.9 OG00145.1

Secondary

Percentage of Participants With Major Molecular Response (MMR) Rates at 24, 36, and 42 Months

Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.

Posted

Number

Percentage of participants

24, 36 and 42 months

ID	Title	Description
OG000	Imatinib 400 mg	Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
OG001	Imatinib 800 mg	Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.

Units	Counts

Secondary

Percentage of Participants With Complete Cytogenetic Response (CCyR) Rate at 12, 24, 36, 42 Months

Cytogenetic response (CyR)is the percentage of Philadelphia chromosome positive metaphases (among at least 20 metaphase cells in bone marrow (BM)) with Complete Cytogenetic Response (CCyR) being 0 percent.

Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.

Posted

Number

Percentage of Participants

12, 24, 36, 42 months

ID	Title	Description
OG000	Imatinib 400 mg	Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
OG001	Imatinib 800 mg	Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.

Units	Counts
Participants

Secondary

Percentage of Participants With Complete Hematological Response (CHR) Rates at 12, 24, 36, and 42 Months

Complete Hematologic Response (CHR) is where all of the following criteria must be present for ≥4 weeks: White Blood Cell (WBC) count <10 x 109/L, Platelet count <450 x 109/L, Basophils <5%, No blasts and promyelocytes in Peripheral Blood (PB), (Myelocytes + metamyelocytes) < 5% in PB and No evidence of extramedullary involvement.

Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.

Posted

Number

Percentage of participants

12, 24, 36, and 42 months

ID	Title	Description
OG000	Imatinib 400 mg	Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
OG001	Imatinib 800 mg	Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.

Secondary

Percentage of Patients With Undetectable Levels of Bcr-Abl (A Fusion Gene of the Breakpoint Cluster Region [Bcr] Gene and Abelson Proto-oncogene [Abl] Genes) Transcripts

"Undetectable levels" or Complete molecular response is defined as Bcr-Abl ratio (%) on international scale (IS) <= 0.0032% (≥ 4.5 log reduction of BCR-Abl transcripts from a standardized baseline).

Intent-to-treat (ITT) population consisted of all patients who were randomized into the study.

Posted

Number

Percentage of Partcipants

12 , 24, 36 and 42 months

ID	Title	Description
OG000	Imatinib 400 mg	Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
OG001	Imatinib 800 mg	Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.

Units	Counts

Secondary

Time to First Major Molecular Response

Time to MMR (months) = (date of first MMR or censoring - date of randomization + 1) / 30.4375. Time to first MMR was evaluated using the Kaplan-Meier method

Intent-to-treat (ITT) population consisted of all patients who were randomized to the study treatment.

Posted

Median

95% Confidence Interval

Months

42 months overall

ID	Title	Description
OG000	Imatinib 400 mg	Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
OG001	Imatinib 800 mg	Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.

Secondary

Time to First Complete Cytogenetic Response

Cytogenetic response (CyR) is the percentage of Philadelphia positive metaphases (among at least 20 metaphase cells in Bone Marrow) with Complete Cytogenetic Response (CCyR) being 0 percent. Time to CCyR (months) = (date of first CCyR or censoring - date of randomization + 1) / 30.4375. Time to first CCyR was evaluated using the Kaplan-Meier method.

Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.

Posted

Median

95% Confidence Interval

Months

60 months overall

ID	Title	Description
OG000	Imatinib 400 mg	Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
OG001	Imatinib 800 mg	Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.

Units	Counts

Secondary

Time to First Complete Hematological Response (CHR)]

Complete Hematological Response (CHR) is defined is where all of the following criteria must be present for ≥4 weeks: White Blood Cell (WBC) count <10 x 109/L, Platelet count <450 x 109/L, Basophils <5%, No blasts and promyelocytes in Peripheral Blood (PB), (Myelocytes + metamyelocytes) < 5% in PB and No evidence of extramedullary involvement. Time to CHR (months) = (date of first CHR or censoring - date of randomization + 1) / 30.4375. Time to first CHR was evaluated using the Kaplan-Meier method.

Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.

Posted

Median

95% Confidence Interval

Months

60 months overall

ID	Title	Description
OG000	Imatinib 400 mg	Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
OG001	Imatinib 800 mg	Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.

Secondary

Estimated Rate of Event Free Survival (EFS) in Two Treatment Arms

EFS on treatment was defined as time between randomization and either (1) death due to any cause during study treatment, (2) progression to accelerated phase (AP) or blast crisis (BC) on treatment, (3) loss of complete hematological response (CHR), or (4) loss of major cytogenic response (MCyR) while on treatment. Estimated rate of EFS was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).

Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.

Posted

Number

95% Confidence Interval

Percent probability

60 months over all

ID	Title	Description
OG000	Imatinib 400 mg	Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
OG001	Imatinib 800 mg	Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.

Secondary

Estimated Rate of Progression Free Survival (PFS) in Two Treatment Arms

PFS on study which was defined as time between randomization and either (1) death due to any cause on treatment of during follow-up after discontinuation of treatment or (2) progression to accelerated phase (AP) or blast crisis (BC) on treatment during follow-up after discontinuation of study treatment. Estimated rate of PFS was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).

Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.

Posted

Number

95% Confidence Interval

Percent probability

60 months over all and follow up period

ID	Title	Description
OG000	Imatinib 400 mg	Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
OG001	Imatinib 800 mg	Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.

Secondary

Estimated Rate of Progression to Accelerated Phase (AC)/Blast Crisis (BC) in Two Treatment Arms

(Accelerated Phase/Blast Crisis) AP/BC was defined as time between randomization and either (1) (Chronic Myeloid Leukemia) CML-related death (if death was primary reason for discontinuation) or (2) progression to AP or BC (during treatment). Estimated rate of AC/BC was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).

Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.

Posted

Number

95% Confidence Interval

Percent probability

60 months over all and follow up period

ID	Title	Description
OG000	Imatinib 400 mg	Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
OG001	Imatinib 800 mg	Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.

Secondary

Estimated Rate of Overall Survival (OS) in Two Treatment Arms

OS was defined as time between randomization and death due to any cause during study treatment or during follow-up after discontinuation of treatment. Estimated rate of OS was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).

Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.

Posted

Number

95% Confidence Interval

Percent probability

60 months over all and follow up period

ID	Title	Description
OG000	Imatinib 400 mg	Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
OG001	Imatinib 800 mg	Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.

Units	Counts

Secondary

Kaplan-Meier Estimates of Duration of First Major Molecular Response Until Confirmed Loss

Duration of MMR (months) = (date of first confirmed loss or censoring - date of MMR + 1 ) / 30.4375. Estimated rate of duration of first MMR was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).

Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.

Posted

Number

95% Confidence Interval

Percent probability

From First major molecular response to first confirmed loss or censoring

ID	Title	Description
OG000	Imatinib 400 mg	Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
OG001	Imatinib 800 mg	Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.

Units	Counts

Secondary

Kaplan-Meier Estimates of Duration of First Complete Cytogenetic Response (CCyR)

Duration of CCyR was defined as the time between date of CCyR and the earliest of either (1) loss of CCyR OR (2) (Chronic Myeloid Leukemia) CML-related death or progression to (Accelerated Phase/Blast Crisis) AP/BC during study treatment. Estimated rate of duration of first CCyR was analyzed by Kaplan-Meier estimate (percent probability and 95% Confidence interval).

Intent-to-treat (ITT) population consisted of all patients who are randomized into the study.

Posted

Number

95% Confidence Interval

Percent probability

From first complete cytogenetic response to first confirmed loss or censoring

ID	Title	Description
OG000	Imatinib 400 mg	Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
OG001	Imatinib 800 mg	Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.

Secondary

Mean Actual Dose Intensity Per Day

The mean actual dose intensity per day from start of treatment up to last dose or discontinuation was evaluated up to Month 36. Actual dose intensity (mg/day) = total dose/time on treatment (periods of zero dose are included)

Safety analysis population (SAP): consisted of all patients who received at least one dose of study medication.Subjects are summarized according to the safety treatment allocation (the dose they actually received).

Posted

Mean

Standard Deviation

mg/day

start of treatment to Month 36

ID	Title	Description
OG000	Imatinib 400 mg	Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
OG001	Imatinib 800 mg	Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.

Units	Counts

Secondary

Imatinib Pharmacokinetic Trough Plasma Concentration (Cmin) at Month 12

Imatinib PK trough plasma concentration (Cmin) was defined as any pre-dose Imatinib plasma concentration

Pharmakokinetic (PK) population consisted of number of patients with a pre-dose PK sample at Month 12

Posted

Mean

Standard Deviation

mg/mL

Month 12

ID	Title	Description
OG000	Imatinib 400 mg	Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
OG001	Imatinib 800 mg	Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.

Units	Counts
Participants

Secondary

Estimated Rates of Progression Free Survival (PFS) on Treatment by Major Molecular Response (MMR)

A Landmark Kaplan-Meier analysis was performed for PFS at 42 months by MMR status at 6, 12, and 18 months to investigate their prognostic value.

Intent-to-treat (ITT) population consisted of all patients who were randomized to the study treatment. Patients without a valid polymerase chain reaction (PCR) assessment or those who had experienced an event before the landmark were excluded from analysis

Posted

Number

95% Confidence Interval

Percent probability

42 months

ID	Title	Description
OG000	Imatinib 400 mg	Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
OG001	Imatinib 800 mg	Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.

Units	Counts

Secondary

Time to First Complete Molecular Response (CMR)]

Complete Molecular Response is defined as a Bcr-Abl (a fusion of gene of Bcr and ABl genes) ratio ≤0.0032% on the International Scale Bcr = breakpoint cluster gene Abl = abelson proto-oncogene.

This analysis was not done because no major molecular improvement was observed in the 800mg dose compared to 400mg dose. Hence, analysis for complete molecular response was not necessary.

Posted

Median

95% Confidence Interval

Months

48 months overall

ID	Title	Description
OG000	Imatinib 400 mg	Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
OG001	Imatinib 800 mg	Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.

Units	Counts
Participants

Secondary

Number of Participants With the Effect of Imatinib on the Diabetic Participants With Known Concomitant Type II Diabetes

Due to the small number of diabetic patients enrolled into the study, the analysis was never done.

Posted

Number

Participants

12 months

ID	Title	Description
OG000	Imatinib 400 mg	Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
OG001	Imatinib 800 mg	Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.

Units	Counts
Participants	OG000

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	Imatinib 400mg	Oral dose of 400mg imatinib once daily. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.			42	157	157	157
EG001	Imatinib 800mg	Patients randomized to receive 800 mg imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.			121	316	315	316

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0003 affected157 at risk EG0016 affected316 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 affected157 at risk EG0015 affected316 at risk
Granulocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0012 affected316 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0005 affected157 at risk EG00112 affected316 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0011 affected316 at risk
Splenic cyst	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0004 affected157 at risk EG0019 affected316 at risk
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected157 at risk EG0010 affected316 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0013 affected316 at risk
Cardiac arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Cardiac discomfort	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0011 affected316 at risk
Coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0011 affected316 at risk
Palpitations	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Deafness	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Hearing impaired	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Hypothyroidism	Endocrine disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Amaurosis	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Conjunctivitis	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Glaucoma	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0012 affected316 at risk
Retinal detachment	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0012 affected316 at risk
Retinal haemorrhage	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Retinal vein occlusion	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Uveitis	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Vitreous haemorrhage	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0013 affected316 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0013 affected316 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Anal polyp	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Caecitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Colitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0013 affected316 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0014 affected316 at risk
Diverticulum	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Enteritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0012 affected316 at risk
Gastritis alcoholic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0013 affected316 at risk
Haematemesis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0012 affected316 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Melaena	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0013 affected316 at risk
Reflux gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0012 affected316 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0014 affected316 at risk
Adverse drug reaction	General disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0012 affected316 at risk
Chest discomfort	General disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0002 affected157 at risk EG0010 affected316 at risk
Concomitant disease progression	General disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Death	General disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Device ineffective	General disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Mucosal inflammation	General disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Polyp	General disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Polyserositis	General disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0003 affected157 at risk EG00113 affected316 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0012 affected316 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0012 affected316 at risk
Liver disorder	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0011 affected316 at risk
Appendicitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0015 affected316 at risk
Bacterial infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Bacterial sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0012 affected316 at risk
Diverticulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0013 affected316 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Febrile infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected157 at risk EG0015 affected316 at risk
Gastroenteritis viral	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Gastrointestinal infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
HIV infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Haematoma infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Herpes zoster	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Meningitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected157 at risk EG0015 affected316 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Pyelonephritis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0011 affected316 at risk
Pyelonephritis acute	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Retroperitoneal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Salmonellosis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0012 affected316 at risk
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Septic shock	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Tooth infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0012 affected316 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0011 affected316 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected157 at risk EG0010 affected316 at risk
Drug exposure during pregnancy	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0011 affected316 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected157 at risk EG0012 affected316 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Alanine aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0011 affected316 at risk
Aspartate aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0011 affected316 at risk
Electrocardiogram T wave abnormal	Investigations	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0012 affected316 at risk
Gout	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0013 affected316 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0013 affected316 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0012 affected316 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0012 affected316 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0012 affected316 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Blast crisis in myelogenous leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 affected157 at risk EG0012 affected316 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Desmoid tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Mycosis fungoides	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0015 affected316 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Thyroid adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0011 affected316 at risk
Cerebral infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Cervical myelopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Epilepsy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
IIIrd nerve paralysis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Migraine	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0011 affected316 at risk
Nerve root compression	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Paraesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0013 affected316 at risk
Parkinsonism	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Radiculopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Spinal cord compression	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0013 affected316 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Abortion incomplete	Pregnancy, puerperium and perinatal conditions	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Neonatal disorder	Pregnancy, puerperium and perinatal conditions	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Placental disorder	Pregnancy, puerperium and perinatal conditions	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0012 affected316 at risk
Premature labour	Pregnancy, puerperium and perinatal conditions	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Confusional state	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0012 affected316 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0013 affected316 at risk
Calculus urinary	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Haematuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Paroxysmal nocturnal haemoglobinuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Renal colic	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Renal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Urethral disorder	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Haemorrhagic ovarian cyst	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Ovarian cyst ruptured	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0011 affected316 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0014 affected316 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0012 affected316 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0014 affected316 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Pregnancy of partner	Social circumstances	MedDRA	Systematic Assessment	EG0002 affected157 at risk EG0012 affected316 at risk
Circulatory collapse	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Extremity necrosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Haematoma	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Hypertensive crisis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Orthostatic hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Peripheral ischaemia	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG0010 affected316 at risk
Vasculitis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected157 at risk EG0011 affected316 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00041 affected157 at risk EG001120 affected316 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00020 affected157 at risk EG00151 affected316 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00038 affected157 at risk EG001107 affected316 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00036 affected157 at risk EG001111 affected316 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA	Systematic Assessment	EG0008 affected157 at risk EG00119 affected316 at risk
Conjunctivitis	Eye disorders	MedDRA	Systematic Assessment	EG0009 affected157 at risk EG00119 affected316 at risk
Eye swelling	Eye disorders	MedDRA	Systematic Assessment	EG0003 affected157 at risk EG00119 affected316 at risk
Eyelid oedema	Eye disorders	MedDRA	Systematic Assessment	EG00021 affected157 at risk EG00145 affected316 at risk
Lacrimation increased	Eye disorders	MedDRA	Systematic Assessment	EG0008 affected157 at risk EG00130 affected316 at risk
Periorbital oedema	Eye disorders	MedDRA	Systematic Assessment	EG00046 affected157 at risk EG001132 affected316 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00013 affected157 at risk EG00117 affected316 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0009 affected157 at risk EG00115 affected316 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00036 affected157 at risk EG00176 affected316 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00038 affected157 at risk EG00154 affected316 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00019 affected157 at risk EG00136 affected316 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00071 affected157 at risk EG001184 affected316 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00021 affected157 at risk EG00157 affected316 at risk
Flatulence	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0007 affected157 at risk EG00120 affected316 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0006 affected157 at risk EG00120 affected316 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0005 affected157 at risk EG00128 affected316 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0006 affected157 at risk EG00125 affected316 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00078 affected157 at risk EG001205 affected316 at risk
Toothache	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00014 affected157 at risk EG00121 affected316 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00054 affected157 at risk EG001140 affected316 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG00022 affected157 at risk EG00148 affected316 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0009 affected157 at risk EG0017 affected316 at risk
Chills	General disorders	MedDRA	Systematic Assessment	EG0009 affected157 at risk EG00118 affected316 at risk
Face oedema	General disorders	MedDRA	Systematic Assessment	EG00013 affected157 at risk EG00164 affected316 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG00051 affected157 at risk EG001131 affected316 at risk
Influenza like illness	General disorders	MedDRA	Systematic Assessment	EG00012 affected157 at risk EG00135 affected316 at risk
Oedema	General disorders	MedDRA	Systematic Assessment	EG00010 affected157 at risk EG00135 affected316 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG00043 affected157 at risk EG001135 affected316 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG00031 affected157 at risk EG00175 affected316 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG00010 affected157 at risk EG00126 affected316 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0008 affected157 at risk EG00126 affected316 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG00017 affected157 at risk EG00118 affected316 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00019 affected157 at risk EG00130 affected316 at risk
Pharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0005 affected157 at risk EG00117 affected316 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG00013 affected157 at risk EG00133 affected316 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00044 affected157 at risk EG00188 affected316 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00017 affected157 at risk EG00126 affected316 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0006 affected157 at risk EG00118 affected316 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0007 affected157 at risk EG00116 affected316 at risk
Alanine aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG00011 affected157 at risk EG00125 affected316 at risk
Aspartate aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG00011 affected157 at risk EG00126 affected316 at risk
Platelet count decreased	Investigations	MedDRA	Systematic Assessment	EG0001 affected157 at risk EG00118 affected316 at risk
Weight decreased	Investigations	MedDRA	Systematic Assessment	EG0006 affected157 at risk EG00126 affected316 at risk
Weight increased	Investigations	MedDRA	Systematic Assessment	EG00026 affected157 at risk EG00154 affected316 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00022 affected157 at risk EG00154 affected316 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0003 affected157 at risk EG00121 affected316 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0008 affected157 at risk EG00128 affected316 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0008 affected157 at risk EG00133 affected316 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00030 affected157 at risk EG00143 affected316 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00048 affected157 at risk EG001107 affected316 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00029 affected157 at risk EG00171 affected316 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00017 affected157 at risk EG00139 affected316 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected157 at risk EG00116 affected316 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00069 affected157 at risk EG001141 affected316 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00010 affected157 at risk EG00114 affected316 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00022 affected157 at risk EG00129 affected316 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00037 affected157 at risk EG00183 affected316 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00010 affected157 at risk EG00116 affected316 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00033 affected157 at risk EG00179 affected316 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG00038 affected157 at risk EG00147 affected316 at risk
Dysgeusia	Nervous system disorders	MedDRA	Systematic Assessment	EG0008 affected157 at risk EG00137 affected316 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG00046 affected157 at risk EG00198 affected316 at risk
Paraesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG00011 affected157 at risk EG00116 affected316 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG00012 affected157 at risk EG00124 affected316 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG00020 affected157 at risk EG00132 affected316 at risk
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG00021 affected157 at risk EG00153 affected316 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00034 affected157 at risk EG00174 affected316 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00010 affected157 at risk EG00144 affected316 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0008 affected157 at risk EG00121 affected316 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00013 affected157 at risk EG00127 affected316 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0009 affected157 at risk EG00138 affected316 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0004 affected157 at risk EG00118 affected316 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00018 affected157 at risk EG00125 affected316 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00015 affected157 at risk EG00141 affected316 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00032 affected157 at risk EG001119 affected316 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG00012 affected157 at risk EG00118 affected316 at risk

ID	Term
D015466	Leukemia, Myeloid, Chronic-Phase
D015464	Leukemia, Myelogenous, Chronic, BCR-ABL Positive

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009196	Myeloproliferative Disorders
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D001549	Benzamides
D000577	Amides
D009930	Organic Chemicals
D001565	Benzoates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011743	Pyrimidines