Study of BMS-354825 (Dasatinib) in Patients With Chronic... | NCT00101660

Label	Type	Description	Intervention Names
Dasatinib, 70 mg twice daily (BID)	Experimental	Dasatanib, 70 mg twice daily (BID), with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.	Drug: Dasatinib

Name	Type	Description	Arm Group Labels	Other Names
Dasatinib	Drug	Tablets; oral; 70 mg BID, depending on response	Dasatinib, 70 mg twice daily (BID)

Measure	Description	Time Frame
Number of Imatinib-resistant Participants With Major Cytogenetic Response (MCyR)	Cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases plus Partial Cytogenetic Response (PCyR)-1% to 35% Ph+ metaphases.	2 years

Measure	Description	Time Frame
Number of Imatinib-intolerant Participants With MCyR	Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.	Baseline to 2 years
Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Anaheim	California		United States
Local Institution

PubMed Identifier	Type	Citation	Retractions
17138817	Background	Hochhaus A, Kantarjian HM, Baccarani M, Lipton JH, Apperley JF, Druker BJ, Facon T, Goldberg SL, Cervantes F, Niederwieser D, Silver RT, Stone RM, Hughes TP, Muller MC, Ezzeddine R, Countouriotis AM, Shah NP. Dasatinib induces notable hematologic and cytogenetic responses in chronic-phase chronic myeloid leukemia after failure of imatinib therapy. Blood. 2007 Mar 15;109(6):2303-9. doi: 10.1182/blood-2006-09-047266. Epub 2006 Nov 30.
19779040

ID	Title	Description
FG000	Imatinib-intolerant	Imatinib intolerance was defined as: Grade 3 or greater nonhematologic toxicity that is imatinib-related or Grade 4 hematologic toxicity that is imatinib-related lasting more than 7 days.
FG001	Imatinib-resistant

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

Number of Imatinib-resistant Participants With Major Cytogenetic Response (MCyR)

Cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases plus Partial Cytogenetic Response (PCyR)-1% to 35% Ph+ metaphases.

All imatinib-resistant participants who received treatment.

Posted

Number

Participants

2 years

ID	Title	Description
OG000	Dasatinib, 70 mg, Twice Daily (BID)	Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.

Units	Counts
Participants	OG000288

Title

Denominators

Categories

Title	Measurements
	OG000159

Secondary

Number of Imatinib-intolerant Participants With MCyR

Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.

All imatinib-intolerant participants who received treatment.

Posted

Number

Participants

Baseline to 2 years

ID	Title	Description
OG000	Dastinib, 70 mg, BID	Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months

Based on the Kaplan-Meier estimate of the duration of response. Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases and Partial Cytogenetic Response (PCyR) - 1% to 35% Ph+ metaphases.

Population is limited to responders (those who acheived MCyR) who were also assessed for duration of MCyR.

Posted

Number

Percentage of participants

12 and 24 Months

ID	Title	Description
OG000	Dasatanib, 70 mg BID	Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.

Units	Counts
Participants	OG000

Secondary

Median Time From First Dosing Date to Date of MCyR

MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.

Population is limited to responders (those who acheived MCyR) only

Posted

Median

Full Range

Months

Baseline (within 4 weeks of Day 1) and every 12 weeks

ID	Title	Description
OG000	Dasatinib, 70 mg BID	Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Complete Hematologic Response (CHR)

CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets <450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.

All participants who received treatment.

Posted

Number

Participants

Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study

ID	Title	Description
OG000	Dasatinib, 70 mg BID	Dasatinib, 70 mg twice BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Acheived CHR and Did Not Progress at 12 Months and 24 Months

Based on the Kaplan-Meier estimate of the duration of response. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.

Population limited to responders (those achieving CHR) only

Posted

Number

Percentage of participants

12 and 24 months

ID	Title	Description
OG000	Dasatinib,70 mg BID	Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.

Units	Counts
Participants	OG000

Secondary

Median Time From First Dosing Until CHR

Population limited to responders (those achieving CHR) only

Posted

Median

Full Range

Months

Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study

ID	Title	Description
OG000	Dasatinib, 70 mg BID	Dasatinib, 70 mg twice BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Major Molecular Response (MMR)

MMR is defined as ≤3 log reduction in BCR-ABL levels from the standardized baseline value of BCR-ABL:Control Gene ratio. The international ratio is obtained by multiplying BCR-ABL:Control gene ratio by the lab-specific conversion factor.

All participants who received treatment.

Posted

Number

Participants

Baseline to 2 years

ID	Title	Description
OG000	Dasatinib, 70 mg BID	Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.

Units	Counts
Participants	OG000

Secondary

Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores

Health-related quality of life as measured by FACT-G, which comprises 27 questions in 4 domains: PWB, SWB, EWB, FWB. Total FACT-G score=summation of the 4 subscale scores and ranges from 0 to 108. Higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, & FWB score change of 3 or more, and SWB score change of 2 or more=minimal clinical important change. Baseline FACT-G measurements can be found in Baseline Characteristics.

Number of participants with assessments at baseline and timepoint

Posted

Number

Participants

Baseline, Day 29, every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment, after end of treatment. Treatment continued until disease progression or development of toxicity or until other protocol-defined criteria.

ID	Title	Description
OG000	Dasatinib,70 mg BID	Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.

Units	Counts
Participants

Secondary

Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE

AE=any new untoward medical occurrence or worsening of a preexisting medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)

All imitanib-intolerant participants who received treatment.

Posted

Number

Participants

Continuously, from baseline through 2 years

ID	Title	Description
OG000	Dasatinib,70 mg BID	Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.

Units	Counts
Participants

Secondary

Number of Imitanib-resistant Participants With Drug-related AEs, Death Within 30 Days of Last Dose, Death, AEs Leading to Discontinuation, SAEs, Grade 3-4 Thrombocytopenia, Grade 3-4 Neutropenia, and Any AE

All imitanib-resistant participants who received treatment.

Posted

Number

Participants

Continuously, from baseline through 2 years

ID	Title	Description
OG000	Dasatinib,70 mg BID	Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance. a

Units	Counts
Participants

Secondary

Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib

Blood samples were collected for PK to be included in separate population PK analyses.

No study-specific PK analyses were planned for this report.

Posted

Number

Participants

Day 8 of study; pretreatment through sample between 30 minutes and 3 hours following treatment, a sample between 5 hours and 8 hours following treatment and a sample at 12 hours, prior to the next dose.

ID	Title	Description
OG000	Dasatinib	Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
LIPASE	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
PROLONGED	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0010 affected288 at risk
PLEUROSCOPY	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
PLATELET COUNT	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0012 affected288 at risk
WEIGHT DECREASED	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
HAEMOGLOBIN DECREASED	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0012 affected288 at risk
BLOOD CULTURE POSITIVE	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
BLOOD CREATINE INCREASED	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
PLATELET COUNT DECREASED	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0012 affected288 at risk
BLOOD POTASSIUM DECREASED	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
BIOPSY BONE MARROW ABNORMAL	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
LIVER FUNCTION TEST ABNORMAL	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
BLOOD CREATINE PHOSPHOKINASE INCREASED	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
ELECTROCARDIOGRAM QT CORRECTED INTERVAL	Investigations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0010 affected288 at risk
CYANOSIS	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
NODAL RHYTHM	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
PALPITATIONS	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
PERICARDITIS	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0011 affected288 at risk
CARDIOMYOPATHY	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected99 at risk EG0011 affected288 at risk
ANGINA UNSTABLE	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0012 affected288 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0017 affected288 at risk
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0013 affected288 at risk
DIASTOLIC DYSFUNCTION	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0011 affected288 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
VENTRICULAR ARRHYTHMIA	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
ACUTE CORONARY SYNDROME	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
LEFT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
MITRAL VALVE INCOMPETENCE	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
VENTRICULAR EXTRASYSTOLES	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected99 at risk EG0019 affected288 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0012 affected288 at risk
LEFT VENTRICULAR DYSFUNCTION	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected99 at risk EG0011 affected288 at risk
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
EMBOLISM	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
HAEMATOMA	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0012 affected288 at risk
HYPERTENSION	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0011 affected288 at risk
CIRCULATORY COLLAPSE	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
GOITRE	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
DEPRESSION	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0011 affected288 at risk
HYPERSENSITIVITY	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0012 affected288 at risk
ANAPHYLACTIC REACTION	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
SYNCOPE	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
HEADACHE	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0011 affected288 at risk
DIZZINESS	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0012 affected288 at risk
NEUROPATHY PERIPHERAL	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
ILEUS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0012 affected288 at risk
COLITIS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0011 affected288 at risk
MELAENA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
VOMITING	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0013 affected288 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected99 at risk EG00110 affected288 at risk
ENTERITIS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
GINGIVITIS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
ANAL FISSURE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
PANCREATITIS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
PERIODONTITIS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0014 affected288 at risk
ANAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0012 affected288 at risk
ABDOMINAL PAIN LOWER	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
OESOPHAGEAL STENOSIS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
HAEMORRHOIDAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
LARGE INTESTINE PERFORATION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0014 affected288 at risk
INGUINAL HERNIA, OBSTRUCTIVE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
ABDOMINAL STRANGULATED HERNIA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0012 affected288 at risk
LOWER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
EAR HAEMORRHAGE	Ear and labyrinth disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0013 affected288 at risk
INFLUENZA	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
PNEUMONIA	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0005 affected99 at risk EG00111 affected288 at risk
BRONCHITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0014 affected288 at risk
CELLULITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected99 at risk EG0014 affected288 at risk
APPENDICITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
OSTEOMYELITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
DIVERTICULITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
PYELONEPHRITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
GASTROENTERITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
LOBAR PNEUMONIA	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
BRONCHOPNEUMONIA	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0012 affected288 at risk
PNEUMONIA FUNGAL	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
FEBRILE INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
VIRAL PHARYNGITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
ESCHERICHIA SEPSIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
PERIRECTAL ABSCESS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
LOCALISED INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
HERPES VIRUS INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
CYTOMEGALOVIRUS COLITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
PHARYNGOLARYNGEAL ABSCESS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
PNEUMOCYSTIS JIROVECI PNEUMONIA	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0012 affected288 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0011 affected288 at risk
POLLAKIURIA	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0014 affected288 at risk
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0012 affected288 at risk
GLOMERULONEPHROPATHY	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
HYSTERECTOMY	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
BONE MARROW TRANSPLANT	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0012 affected288 at risk
CORONARY ARTERIAL STENT INSERTION	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
ANOREXIA	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0013 affected288 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
HYPERCALCAEMIA	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected99 at risk EG0016 affected288 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
LEUKOCYTOSIS	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0012 affected288 at risk
SPLENOMEGALY	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0018 affected288 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected99 at risk EG0017 affected288 at risk
ACNE	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
SKIN DISORDER	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
SKIN NECROSIS	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
ENDOMETRIOSIS	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
UTERINE HAEMORRHAGE	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
OVERDOSE	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
SKIN LACERATION	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
JOINT DISLOCATION	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
ACCIDENTAL OVERDOSE	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
FACIAL BONES FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
PROCEDURAL COMPLICATION	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0013 affected288 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0012 affected288 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0012 affected288 at risk
TENOSYNOVITIS	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
RHABDOMYOLYSIS	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
STRIDOR	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0008 affected99 at risk EG00115 affected288 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0011 affected288 at risk
CHYLOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0012 affected288 at risk
BRONCHOSPASM	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
LUNG DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
PLEURAL DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00016 affected99 at risk EG00132 affected288 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
LUNG INFILTRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0015 affected288 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
BRONCHIAL OBSTRUCTION	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
NASAL SEPTUM DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
PULMONARY HYPERTENSION	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected99 at risk EG0010 affected288 at risk
INTERSTITIAL LUNG DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
PAIN	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
DEATH	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
FATIGUE	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0013 affected288 at risk
MALAISE	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0011 affected288 at risk
PYREXIA	General disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected99 at risk EG00126 affected288 at risk
ASTHENIA	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
CHEST PAIN	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0012 affected288 at risk
ADVERSE EVENT	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
METASTASIS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
SKIN CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0011 affected288 at risk
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
LEIOMYOSARCOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0012 affected288 at risk
MYELODYSPLASTIC SYNDROME	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
CHRONIC MYELOID LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0015 affected288 at risk
CHRONIC LYMPHOCYTIC LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected99 at risk EG0010 affected288 at risk
SQUAMOUS CELL CARCINOMA OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
METASTATIC SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk
BLAST CRISIS IN MYELOGENOUS LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected99 at risk EG0011 affected288 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
EYELID OEDEMA	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected99 at risk EG0016 affected288 at risk
VISION BLURRED	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0008 affected99 at risk EG00112 affected288 at risk
WEIGHT DECREASED	Investigations	MedDRA 10.0	Systematic Assessment	EG00012 affected99 at risk EG00139 affected288 at risk
WEIGHT INCREASED	Investigations	MedDRA 10.0	Systematic Assessment	EG00010 affected99 at risk EG00130 affected288 at risk
PALPITATIONS	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected99 at risk EG00116 affected288 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected99 at risk EG00113 affected288 at risk
FLUSHING	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0009 affected99 at risk EG00114 affected288 at risk
HOT FLUSH	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected99 at risk EG00114 affected288 at risk
HYPERTENSION	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0009 affected99 at risk EG00119 affected288 at risk
ANXIETY	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected99 at risk EG00117 affected288 at risk
INSOMNIA	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG00014 affected99 at risk EG00133 affected288 at risk
DEPRESSION	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG00010 affected99 at risk EG00120 affected288 at risk
HEADACHE	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00049 affected99 at risk EG001128 affected288 at risk
DIZZINESS	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG00017 affected99 at risk EG00156 affected288 at risk
DYSGEUSIA	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected99 at risk EG00110 affected288 at risk
PARAESTHESIA	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected99 at risk EG00133 affected288 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00040 affected99 at risk EG001108 affected288 at risk
COLITIS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected99 at risk EG0016 affected288 at risk
VOMITING	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00017 affected99 at risk EG00164 affected288 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00044 affected99 at risk EG001153 affected288 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00013 affected99 at risk EG00119 affected288 at risk
TOOTHACHE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected99 at risk EG00115 affected288 at risk
FLATULENCE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0009 affected99 at risk EG00118 affected288 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected99 at risk EG00115 affected288 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0008 affected99 at risk EG00154 affected288 at risk
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00011 affected99 at risk EG00117 affected288 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00017 affected99 at risk EG00147 affected288 at risk
MOUTH ULCERATION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected99 at risk EG00115 affected288 at risk
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0009 affected99 at risk EG00127 affected288 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG00014 affected99 at risk EG00136 affected288 at risk
SINUSITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0008 affected99 at risk EG00117 affected288 at risk
BRONCHITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0008 affected99 at risk EG00123 affected288 at risk
ORAL HERPES	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0004 affected99 at risk EG00124 affected288 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00017 affected99 at risk EG00153 affected288 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0004 affected99 at risk EG00119 affected288 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00019 affected99 at risk EG00136 affected288 at risk
ANOREXIA	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG00016 affected99 at risk EG00152 affected288 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG00012 affected99 at risk EG00133 affected288 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG00016 affected99 at risk EG00152 affected288 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG00012 affected99 at risk EG00167 affected288 at risk
ACNE	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG00012 affected99 at risk EG00117 affected288 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG00043 affected99 at risk EG001103 affected288 at risk
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG00015 affected99 at risk EG00124 affected288 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0009 affected99 at risk EG00118 affected288 at risk
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG00011 affected99 at risk EG00119 affected288 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG00018 affected99 at risk EG00136 affected288 at risk
URTICARIA	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected99 at risk EG00110 affected288 at risk
SKIN LESION	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0009 affected99 at risk EG00118 affected288 at risk
NIGHT SWEATS	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected99 at risk EG00134 affected288 at risk
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected99 at risk EG00117 affected288 at risk
PERIORBITAL OEDEMA	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG00013 affected99 at risk EG00128 affected288 at risk
DERMATITIS ACNEIFORM	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected99 at risk EG0019 affected288 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0005 affected99 at risk EG00121 affected288 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00019 affected99 at risk EG00149 affected288 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00019 affected99 at risk EG00153 affected288 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00010 affected99 at risk EG00148 affected288 at risk
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected99 at risk EG00124 affected288 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00015 affected99 at risk EG00186 affected288 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00010 affected99 at risk EG00127 affected288 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00018 affected99 at risk EG00158 affected288 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG00012 affected99 at risk EG00127 affected288 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected99 at risk EG00117 affected288 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00036 affected99 at risk EG001110 affected288 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00046 affected99 at risk EG001128 affected288 at risk
WHEEZING	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected99 at risk EG0019 affected288 at risk
DYSPHONIA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected99 at risk EG0017 affected288 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected99 at risk EG00127 affected288 at risk
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected99 at risk EG0019 affected288 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00037 affected99 at risk EG00190 affected288 at risk
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected99 at risk EG00121 affected288 at risk
PHARYNGOLARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00014 affected99 at risk EG00142 affected288 at risk
PAIN	General disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected99 at risk EG00121 affected288 at risk
CHILLS	General disorders	MedDRA 10.0	Systematic Assessment	EG00010 affected99 at risk EG00131 affected288 at risk
OEDEMA	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected99 at risk EG00115 affected288 at risk
FATIGUE	General disorders	MedDRA 10.0	Systematic Assessment	EG00048 affected99 at risk EG001136 affected288 at risk
PYREXIA	General disorders	MedDRA 10.0	Systematic Assessment	EG00033 affected99 at risk EG001104 affected288 at risk
ASTHENIA	General disorders	MedDRA 10.0	Systematic Assessment	EG00019 affected99 at risk EG00158 affected288 at risk
CHEST PAIN	General disorders	MedDRA 10.0	Systematic Assessment	EG00017 affected99 at risk EG00135 affected288 at risk
CHEST DISCOMFORT	General disorders	MedDRA 10.0	Systematic Assessment	EG00010 affected99 at risk EG00119 affected288 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 10.0	Systematic Assessment	EG00024 affected99 at risk EG00175 affected288 at risk
INFLUENZA LIKE ILLNESS	General disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected99 at risk EG00119 affected288 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Intolerant				48	99	96	99
EG001	Resistant				146	288	287	288

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
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011743	Pyrimidines

ID	Title	Description
BG000	Imatinib-intolerant	Imatinib intolerance was defined as: Grade 3 or greater nonhematologic toxicity that is imatinib-related or Grade 4 hematologic toxicity that is imatinib-related lasting more than 7 days.
BG001	Imatinib-resistant	Imatinib resistance, acquired or primary. Acquired resistance: participants who achieve major cytogenetic response (MCyR) or complete hematologic response (CHR) on imatinib at any dose prior to progression, defined by 1 of the following: loss of MCyR, loss of CHR, or increasing white blood cell (WBC) count. Primary resistance: participants who never achieve MCyR or CHR at any dose, and meet 1 of the following: continuously increasing WBC count on at least 2 consecutive evaluations at least 2 weeks apart, with the final assessment showing a doubling of WBC from nadir to ≥20,000/mm^3; an absolute increase in WBC by more than 50,000/mm^3 above lowest count after starting imatinib; no CHR after 3 months; no cytogenetic response (CyR) after 6 months; or no MCyR after 12 months. Resistance was also defined as chronic myeloid leukemia (CML) with resistance to imatinib ≤600mg/d with genetic mutation in BCR-ABL gene (L248V, G250E, Q252H/R, Y253H/F, E255K/V, T315I/D, F317L, H369P/R).
BG002	Total	Total of all reporting groups