Extension to QTI571A2301 to Evaluate the Long-term Safety... | NCT01117987

NCT01117987

ID	Type	Description	Link
2009-018167-26

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Core imatinib	Experimental	Depending on the participants' randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.	Drug: Imatinib Drug: Placebo
Core placebo	Experimental	Depending on the participants' randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.	Drug: Imatinib Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Imatinib	Drug	Participants, who received imatinib 200 mg in the core study, CQTI571A2301 (NCT00902174), and completed the core study, received imatinib 200 mg every day (qd) in the extension. Participants, who were randomized to receive imatinib 400 mg in the core study and completed the core study, received imatinib 400 mg qd in the extension. Participants, who terminated early from the core study or who were randomized to placebo and completed the core study, started the extension with imatinib 200 mg qd. After 2 weeks, the dose was increased to 400 mg qd if tolerated.

Measure	Description	Time Frame
Number of Participants With Adverse Events, Serious Adverse Events and Deaths	Adverse event monitoring was conducted throughout the study.	204 weeks

Measure	Description	Time Frame
Change From Core Study Baseline in Six-Minute Walk Distance (6MWD)	A six minute walk test (6MWT) was performed in accordance with the guidleines of the American Thoracic Society (2002).	core study baseline, extension baseline, 12 weeks, 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 156 weeks, 204 weeks

Eligibility Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Birmingham	Alabama	35294-0006	United States
Novartis Investigative Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Core Imatinib	Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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 Participants With Adverse Events, Serious Adverse Events and Deaths

Adverse event monitoring was conducted throughout the study.

Safety analysis set: The safety set included all paticipants who received at least one dose of study drug during the extension.

Posted

Number

Participants

204 weeks

ID	Title	Description
OG000	Core Imatinib	Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
OG001	Core Placebo	Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.

Units	Counts
Participants	OG00066 OG00178

Title

Denominators

Categories

Adverse events (non-serious and serious)

Title	Measurements
	OG00062 OG00176

Serious adverse events

Title	Measurements
	OG000

Secondary

Change From Core Study Baseline in Six-Minute Walk Distance (6MWD)

A six minute walk test (6MWT) was performed in accordance with the guidleines of the American Thoracic Society (2002).

Participants from the Full Analysis Set (FAS), who had values at both core study baseline and the given post-baseline time point, were included in the analysis for that post-baseline time point. The FAS included all participants who received at least one dose of study drug during the extension.

Posted

Mean

Standard Deviation

meters

core study baseline, extension baseline, 12 weeks, 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 156 weeks, 204 weeks

ID	Title	Description
OG000	Core Imatinib	Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
OG001	Core Placebo	Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.

Secondary

Percentage of Participants With Incidence of Clinical Worsening Events

Clinical worsening events included death, overnight hospitalization for worsening of PAH, worsening of World Health Organization (WHO) functional class by at least one level (drop in WHO ), 15% decrease in the 6MWD as compared to baseline confirmed by two 6MWTs at two consecutive study visits (6MWD reduction), and drop in WHO & 6MWD reduction. Some participants have fulfilled more than one criterion. Therefore, the sum of individual components may be higher than the total number of participants with clinical worsening.

Full Analysis Set (FAS): The full analysis set included all participants who received at least one dose of study drug during the extension.

Posted

Number

Percentage of participants

204 weeks

ID	Title	Description
OG000	Core Imatinib	Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
OG001	Core Placebo	Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agranulocytosis	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0003 affected66 at risk EG0012 affected78 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 affected66 at risk EG0010 affected78 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0013 affected78 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Atrial flutter	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0011 affected78 at risk
Atrial tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Bradycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Cardiac arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Cardiac tamponade	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0012 affected78 at risk
Cor pulmonale	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Pericardial effusion	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Right ventricular failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0005 affected66 at risk EG0018 affected78 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Deafness	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Hyperthyroidism	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0011 affected78 at risk
Astigmatism	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Cataract	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Corneal erosion	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Glaucoma	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Periorbital oedema	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0011 affected78 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Colitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Colonic fistula	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected66 at risk EG0010 affected78 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0011 affected78 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0011 affected78 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Haematemesis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0013 affected78 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected66 at risk EG0012 affected78 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Brain death	General disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Chills	General disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Device dislocation	General disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Device leakage	General disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Device malfunction	General disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Device occlusion	General disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Exercise tolerance decreased	General disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Medical device complication	General disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0011 affected78 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0013 affected78 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0012 affected78 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Hepatitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Bacteraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Clostridium difficile infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Colonic abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Device related infection	Infections and infestations	MedDRA	Systematic Assessment	EG0005 affected66 at risk EG0013 affected78 at risk
Device related sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Diverticulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Gastroenteritis viral	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Herpes zoster	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0011 affected78 at risk
Lobar pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Mastitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Mycobacterial infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected66 at risk EG0013 affected78 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Pyelonephritis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Soft tissue infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0011 affected78 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Viral infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Bone contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Complications of transplanted lung	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0013 affected78 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Blood potassium increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Eosinophil percentage increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Haematocrit decreased	Investigations	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Intraocular pressure increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
N-terminal prohormone brain natriuretic peptide	Investigations	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0013 affected78 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0012 affected78 at risk
Gout	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0011 affected78 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Systemic sclerosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0011 affected78 at risk
Cerebral infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Convulsion	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0011 affected78 at risk
Presyncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0012 affected78 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected66 at risk EG0017 affected78 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Bipolar disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Confusional state	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Lupus nephritis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Renal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0012 affected78 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 affected66 at risk EG0012 affected78 at risk
Renal impairment	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Dysfunctional uterine bleeding	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Ovarian cyst ruptured	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Apnoeic attack	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected66 at risk EG0015 affected78 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected66 at risk EG0011 affected78 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0012 affected78 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0011 affected78 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0006 affected66 at risk EG0018 affected78 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0012 affected78 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected66 at risk EG0012 affected78 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0012 affected78 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Scleroedema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0010 affected78 at risk
Telangiectasia	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Craniotomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Arteriovenous fistula	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Haematoma	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0011 affected78 at risk
Hypertensive crisis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected66 at risk EG0011 affected78 at risk
Thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0011 affected78 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0005 affected66 at risk EG0018 affected78 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0005 affected66 at risk EG0016 affected78 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0019 affected78 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0006 affected66 at risk EG0017 affected78 at risk
Palpitations	Cardiac disorders	MedDRA	Systematic Assessment	EG0004 affected66 at risk EG0014 affected78 at risk
Pericardial effusion	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0014 affected78 at risk
Tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0004 affected66 at risk EG0014 affected78 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA	Systematic Assessment	EG0002 affected66 at risk EG0015 affected78 at risk
Periorbital oedema	Eye disorders	MedDRA	Systematic Assessment	EG00011 affected66 at risk EG00123 affected78 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected66 at risk EG0015 affected78 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 affected66 at risk EG0013 affected78 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0006 affected66 at risk EG0015 affected78 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected66 at risk EG0015 affected78 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected66 at risk EG0015 affected78 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00018 affected66 at risk EG00127 affected78 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected66 at risk EG0014 affected78 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0014 affected78 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00021 affected66 at risk EG00139 affected78 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00014 affected66 at risk EG00125 affected78 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0004 affected66 at risk EG0012 affected78 at risk
Chest discomfort	General disorders	MedDRA	Systematic Assessment	EG0002 affected66 at risk EG0014 affected78 at risk
Face oedema	General disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0014 affected78 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0009 affected66 at risk EG00111 affected78 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0004 affected66 at risk EG0014 affected78 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG00021 affected66 at risk EG00132 affected78 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0009 affected66 at risk EG0015 affected78 at risk
Seasonal allergy	Immune system disorders	MedDRA	Systematic Assessment	EG0003 affected66 at risk EG0014 affected78 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0018 affected78 at risk
Device related infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0014 affected78 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0005 affected66 at risk EG0012 affected78 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00017 affected66 at risk EG00124 affected78 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0014 affected78 at risk
Respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected66 at risk EG0017 affected78 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0006 affected66 at risk EG00111 affected78 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected66 at risk EG0018 affected78 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0004 affected66 at risk EG0011 affected78 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0004 affected66 at risk EG0011 affected78 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected66 at risk EG0014 affected78 at risk
Blood creatinine increased	Investigations	MedDRA	Systematic Assessment	EG0004 affected66 at risk EG0013 affected78 at risk
Weight decreased	Investigations	MedDRA	Systematic Assessment	EG0005 affected66 at risk EG0013 affected78 at risk
Weight increased	Investigations	MedDRA	Systematic Assessment	EG0004 affected66 at risk EG0014 affected78 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected66 at risk EG0014 affected78 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0014 affected78 at risk
Gout	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected66 at risk EG0014 affected78 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0005 affected66 at risk EG00110 affected78 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0005 affected66 at risk EG0010 affected78 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0005 affected66 at risk EG00112 affected78 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0006 affected66 at risk EG0014 affected78 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0008 affected66 at risk EG00112 affected78 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 affected66 at risk EG0012 affected78 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected66 at risk EG0014 affected78 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0006 affected66 at risk EG0015 affected78 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0009 affected66 at risk EG0015 affected78 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG00012 affected66 at risk EG00124 affected78 at risk
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 affected66 at risk EG0015 affected78 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00016 affected66 at risk EG00111 affected78 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00010 affected66 at risk EG0016 affected78 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0006 affected66 at risk EG0016 affected78 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected66 at risk EG0014 affected78 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0005 affected66 at risk EG0012 affected78 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0008 affected66 at risk EG0011 affected78 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected66 at risk EG0014 affected78 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0003 affected66 at risk EG0014 affected78 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected66 at risk EG0016 affected78 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0007 affected66 at risk EG00113 affected78 at risk
Flushing	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected66 at risk EG0015 affected78 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0006 affected66 at risk EG0013 affected78 at risk

ID	Term
D000081029	Pulmonary Arterial Hypertension
D006976	Hypertension, Pulmonary

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

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

ID	Title	Description
BG000	Core Imatinib	Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
BG001	Core Placebo	Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Core Imatinib	Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.			40	66	55	66
EG001	Core Placebo	Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.			53	78	72	78