Combined Antiinflammatory and Angiostatic Therapy in Pati... | NCT00427999

ID	Type	Description	Link
2006-000218-19

Status Module

Label	Type	Description	Intervention Names
STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane	Experimental	STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks	Drug: imatinib mesylate Drug: Treosulfane Drug: etoricoxib Drug: pioglitazone Drug: dexamethasone

Name	Type	Description	Arm Group Labels	Other Names
imatinib mesylate	Drug		STI571+ pioglitazone+ etoricoxib + dexamethasone + treosulfane	Gleevec Glivec

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PSA Response Rate	To investigate the effect of a treatment with Imatinib mesylate, Pioglitazone , Etoricoxib, and Dexamethasone in combination with metronomic chemotherapy (Treosulfane) on the PSA response rate in patients with hormone refractory prostate cancer. A patient will be defined as a responder if a PSA decline of at least 50%, which must be confirmed by a second PSA value 4 weeks later, is observed. A patient will be defined as a non-responder if PSA has not decreased during treatment. Non-response is defined as a 25% increase over the baseline on-study which is confirmed (equal or more) by a second value 4 weeks apart. The absolute increase must account for > 5 ng/ml.	up to 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Time to PSA Response	Time to PSA response, defined as the time from first administration of study drugs to the first PSA value of a confirmed PSA response. Non-responders will be censored with date of final visit/premature discontinuation for the analysis. Median time to PSA response was not achieved	every 4 weeks up to 24 weeks

Eligibility Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director
Novartis Pharmaceuticals	Novartis Pharmeceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Bad Reichenhall		83435	Germany
Novartis Investigative Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane	STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane	STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks

Units	Counts
Participants	BG00065

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

PSA Response Rate

To investigate the effect of a treatment with Imatinib mesylate, Pioglitazone , Etoricoxib, and Dexamethasone in combination with metronomic chemotherapy (Treosulfane) on the PSA response rate in patients with hormone refractory prostate cancer. A patient will be defined as a responder if a PSA decline of at least 50%, which must be confirmed by a second PSA value 4 weeks later, is observed. A patient will be defined as a non-responder if PSA has not decreased during treatment. Non-response is defined as a 25% increase over the baseline on-study which is confirmed (equal or more) by a second value 4 weeks apart. The absolute increase must account for > 5 ng/ml.

Intent to Treat (ITT) includes the 61 patients treated.

Posted

Number

participants

up to 24 weeks

ID	Title	Description
OG000	STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane	STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks

Units	Counts
Participants	OG00061

Title

Denominators

Categories

PSA responder - No

Title	Measurements
	OG00038

PSA responder - Yes

Title	Measurements
	OG00023

Secondary

Time to PSA Response

Time to PSA response, defined as the time from first administration of study drugs to the first PSA value of a confirmed PSA response. Non-responders will be censored with date of final visit/premature discontinuation for the analysis. Median time to PSA response was not achieved

Intent to Treat (ITT) includes the 61 patients treated.

Posted

Median

95% Confidence Interval

days

every 4 weeks up to 24 weeks

ID	Title	Description
OG000	STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane	STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks

Units	Counts
Participants	OG000

Secondary

Time to Progression-free Survival

Progression-free survival, defined as the time from first administration of study drugs to the first PSA value of a PSA non-responder. Responders will be censored with date of PSA response for the analysis. The median time to PSA progression free survival was not achieved

Intent to Treat (ITT) includes the 61 patients treated.

Posted

Median

95% Confidence Interval

days

every 4 weeks up to 24 weeks

ID	Title	Description
OG000	STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane	STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks

Units	Counts
Participants	OG000

Secondary

Overall Survival Rate

Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. The median time to overall survival rate was not achieved

Intent to Treat (ITT) includes the 61 patients treated.

Posted

Median

95% Confidence Interval

days

every 4 weeks up to 24 weeks

ID	Title	Description
OG000	STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane	STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks

Units	Counts
Participants	OG000

Secondary

Quality of Life Assessed With EORTC-30

Health-related quality of life was assessed with the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-30) questionnaire and was presented descriptively. The EORTC QLQ-C30 is a questionnaire including following sub-scales: global health status, functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social activity), symptom scales (fatigue, nausea and vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties). Scores are averaged for each scale and transformed to 0-100 scale; higher score indicates better quality of life on global health status and functional scales and worse quality of life on symptom scales and financial difficulty scale.

Intent to Treat (ITT) includes the 61 patients treated

Posted

Mean

Standard Deviation

scores on a scale

baseline and Final Visit (week 24)

ID	Title	Description
OG000	STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane	STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0003 affected65 at risk EG0010 affected19 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0010 affected19 at risk
Right ventricular failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Cataract	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Eyelid oedema	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Haematemesis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Ileus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0010 affected19 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Disease progression	General disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Drug ineffective	General disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Drug intolerance	General disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
General physical health deterioration	General disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0012 affected19 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Hepatitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Haematoma infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0010 affected19 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected65 at risk EG0010 affected19 at risk
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0010 affected19 at risk
Skin infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Urosepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Blood creatinine increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
C-reactive protein increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Haemoglobin decreased	Investigations	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0011 affected19 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0010 affected19 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0010 affected19 at risk
Burning sensation	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Paraesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Paraplegia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Paresis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Anxiety disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Bladder obstruction	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Bladder tamponade	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Haematuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Haemorrhage urinary tract	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Postrenal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0010 affected19 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Urinary retention	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0010 affected19 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Diabetic vascular disorder	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Venous thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0010 affected19 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00021 affected65 at risk EG0017 affected19 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00019 affected65 at risk EG0017 affected19 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0011 affected19 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0004 affected65 at risk EG0010 affected19 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0007 affected65 at risk EG0013 affected19 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Cushing's syndrome	Endocrine disorders	MedDRA	Systematic Assessment	EG00011 affected65 at risk EG0011 affected19 at risk
Cushingoid	Endocrine disorders	MedDRA	Systematic Assessment	EG0004 affected65 at risk EG0013 affected19 at risk
Hypogonadism male	Endocrine disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Eyelid oedema	Eye disorders	MedDRA	Systematic Assessment	EG0005 affected65 at risk EG0012 affected19 at risk
Lacrimation increased	Eye disorders	MedDRA	Systematic Assessment	EG0008 affected65 at risk EG0010 affected19 at risk
Visual acuity reduced	Eye disorders	MedDRA	Systematic Assessment	EG0003 affected65 at risk EG0011 affected19 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0005 affected65 at risk EG0012 affected19 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 affected65 at risk EG0012 affected19 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00027 affected65 at risk EG0016 affected19 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0012 affected19 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00028 affected65 at risk EG0015 affected19 at risk
Toothache	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected65 at risk EG0011 affected19 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00016 affected65 at risk EG0013 affected19 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0007 affected65 at risk EG0011 affected19 at risk
Face oedema	General disorders	MedDRA	Systematic Assessment	EG00015 affected65 at risk EG0014 affected19 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG00021 affected65 at risk EG0019 affected19 at risk
General physical health deterioration	General disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0013 affected19 at risk
Generalised oedema	General disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0012 affected19 at risk
Inflammation	General disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Influenza like illness	General disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Malaise	General disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Mucosal inflammation	General disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Necrosis	General disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Oedema	General disorders	MedDRA	Systematic Assessment	EG00024 affected65 at risk EG0016 affected19 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG00035 affected65 at risk EG00112 affected19 at risk
Pain	General disorders	MedDRA	Systematic Assessment	EG0005 affected65 at risk EG0010 affected19 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0012 affected19 at risk
Hepatitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0012 affected19 at risk
Gingivitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0012 affected19 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0011 affected19 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0007 affected65 at risk EG0013 affected19 at risk
Otitis media	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0005 affected65 at risk EG0010 affected19 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0012 affected19 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Alanine aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG0004 affected65 at risk EG0010 affected19 at risk
Aspartate aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG0005 affected65 at risk EG0010 affected19 at risk
Blood albumin decreased	Investigations	MedDRA	Systematic Assessment	EG0003 affected65 at risk EG0012 affected19 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA	Systematic Assessment	EG0007 affected65 at risk EG0011 affected19 at risk
Blood creatinine increased	Investigations	MedDRA	Systematic Assessment	EG0009 affected65 at risk EG0015 affected19 at risk
Blood fibrinogen increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA	Systematic Assessment	EG00010 affected65 at risk EG0014 affected19 at risk
Blood potassium decreased	Investigations	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0011 affected19 at risk
C-reactive protein increased	Investigations	MedDRA	Systematic Assessment	EG0004 affected65 at risk EG0013 affected19 at risk
Haematocrit decreased	Investigations	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0012 affected19 at risk
Lymphocyte count decreased	Investigations	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Monocyte count decreased	Investigations	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Monocyte count increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Occult blood	Investigations	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Platelet count decreased	Investigations	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Prostatic specific antigen increased	Investigations	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0012 affected19 at risk
Protein total decreased	Investigations	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Red blood cell count decreased	Investigations	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0012 affected19 at risk
Reticulocyte count increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Weight increased	Investigations	MedDRA	Systematic Assessment	EG00013 affected65 at risk EG0013 affected19 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0012 affected19 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0008 affected65 at risk EG0015 affected19 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Obesity	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Zinc deficiency	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0005 affected65 at risk EG0011 affected19 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0007 affected65 at risk EG0014 affected19 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 affected65 at risk EG0012 affected19 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00016 affected65 at risk EG0015 affected19 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0011 affected19 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0012 affected19 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 affected65 at risk EG0010 affected19 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0011 affected19 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected65 at risk EG0015 affected19 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 affected65 at risk EG0011 affected19 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Ageusia	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 affected65 at risk EG0011 affected19 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0006 affected65 at risk EG0010 affected19 at risk
Dysgeusia	Nervous system disorders	MedDRA	Systematic Assessment	EG0007 affected65 at risk EG0011 affected19 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG00011 affected65 at risk EG0011 affected19 at risk
Memory impairment	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Paraesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0012 affected19 at risk
Polyneuropathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0007 affected65 at risk EG0016 affected19 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0004 affected65 at risk EG0010 affected19 at risk
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG0006 affected65 at risk EG0010 affected19 at risk
Sleep disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0006 affected65 at risk EG0013 affected19 at risk
Kidney fibrosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Pollakiuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Renal pain	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected65 at risk EG0011 affected19 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00023 affected65 at risk EG0018 affected19 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0012 affected19 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0005 affected65 at risk EG0010 affected19 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0008 affected65 at risk EG0012 affected19 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0007 affected65 at risk EG0010 affected19 at risk
Skin atrophy	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Skin dystrophy	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected65 at risk EG0011 affected19 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Extravasation blood	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Haemorrhage	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0003 affected65 at risk EG0012 affected19 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0005 affected65 at risk EG0010 affected19 at risk
Lymphoedema	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected65 at risk EG0011 affected19 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk
Peripheral venous disease	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected65 at risk EG0011 affected19 at risk

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases

ID	Term
D000068877	Imatinib Mesylate
C018404	treosulfan
D000077613	Etoricoxib
D000077205	Pioglitazone
D003907	Dexamethasone
C018038	dexamethasone acetate

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
D013450	Sulfones
D013457	Sulfur Compounds
D011725	Pyridines
D045162	Thiazolidinediones
D013844	Thiazoles
D001393	Azoles
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	STI571+Pioglitazone+Etoricoxib+Dexamethasone+Treosulfane(Core)	STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks (Core)			22	65	65	65
EG001	STI571+Pioglitazone+Etoricoxib+Dexamethasone+Treosulfane(Ext)	Extension follow-up			7	19	19	19