A Study of AMNN107 in the Treatment of Metastatic and/or... | NCT01028222

ID	Type	Description	Link
2009-015514-21	EudraCT Number

Label	Type	Description	Intervention Names
Nilotinib	Experimental	400 mg twice daily	Drug: Nilotinib
DTIC	Active Comparator	850 mg/m2 IV every 3 weeks	Drug: DTIC

Name	Type	Description	Arm Group Labels	Other Names
Nilotinib	Drug	Nilotinib was provided as 200 mg hard gelatin capsules for oral use.	Nilotinib

Measure	Description	Time Frame
Overall Response Rate (ORR)	ORR was defined as the proportion of participants with a best overall response (BOR) of a confirmed complete response or partial response (CR+PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) based on local investigators' assessment (CT/MRI/photography). Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.	End of study (up to 39 months)

Measure	Description	Time Frame
Durable Overall Response Rate (DORR)	DORR was defined as the rate of best overall response (CR+PR) lasting at least 12 weeks determined by RECIST v1.0 based on local investigators' assessment (CT/MRI/photography). The duration of ORR responders is computed from the date of first documented response (CR/PR) to the date of first documented progression or death due to underlying disease. Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no worsening of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope National Medical Center City of Hope national Med Ctr		Duarte	California	91010-3000	United States

PubMed Identifier	Type	Citation	Retractions
28327988	Derived	Guo J, Carvajal RD, Dummer R, Hauschild A, Daud A, Bastian BC, Markovic SN, Queirolo P, Arance A, Berking C, Camargo V, Herchenhorn D, Petrella TM, Schadendorf D, Sharfman W, Testori A, Novick S, Hertle S, Nourry C, Chen Q, Hodi FS. Efficacy and safety of nilotinib in patients with KIT-mutated metastatic or inoperable melanoma: final results from the global, single-arm, phase II TEAM trial. Ann Oncol. 2017 Jun 1;28(6):1380-1387. doi: 10.1093/annonc/mdx079.

Label	URL
Related Info	View source

ID	Title	Description
FG000	Nilotinib	400 mg twice daily
FG001	DTIC	850 mg/m2 IV every 3 weeks

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

Overall Response Rate (ORR)

ORR was defined as the proportion of participants with a best overall response (BOR) of a confirmed complete response or partial response (CR+PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) based on local investigators' assessment (CT/MRI/photography). Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.

Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.

Posted

Number

Participants

End of study (up to 39 months)

ID	Title	Description
OG000	Nilotinib	400 mg twice daily
OG001	DTIC	850 mg/m2 IV every 3 weeks

Units	Counts
Participants	OG00042 OG00113

Title

Denominators

Categories

Title	Measurements
	OG00011 OG0013

Secondary

Durable Overall Response Rate (DORR)

DORR was defined as the rate of best overall response (CR+PR) lasting at least 12 weeks determined by RECIST v1.0 based on local investigators' assessment (CT/MRI/photography). The duration of ORR responders is computed from the date of first documented response (CR/PR) to the date of first documented progression or death due to underlying disease. Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no worsening of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.

Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.

Posted

Number

Participants

End of study (up to 39 months)

ID	Title	Description
OG000	Nilotinib	400 mg twice daily
OG001	DTIC	850 mg/m2 IV every 3 weeks

Units	Counts
Participants

Secondary

Progression Free Survival (PFS)

PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined using RECIST v1.0, as a >=20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or unequivocal progression of non-target lesions.

Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.

Posted

Median

95% Confidence Interval

Months

End of study (up to 39 months)

ID	Title	Description
OG000	Nilotinib	400 mg twice daily
OG001	DTIC	850 mg/m2 IV every 3 weeks

Units	Counts
Participants	OG000

Secondary

Overall Survival (OS)

OS was defined as the time from the date of the start of treatment to the date of death due to any cause.

Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.

Posted

Median

95% Confidence Interval

Months

End of study (up to 39 months)

ID	Title	Description
OG000	Nilotinib	400 mg twice daily
OG001	DTIC	850 mg/m2 IV every 3 weeks

Units	Counts
Participants	OG000

Secondary

Time to Objective Response (TOR)

TOR was defined as the time between the start date of treatment until first documented confirmed response of CR or PR determined by RECIST v1.0 based on local investigators' assessment (CT/MRI/photography). Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.

Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.

Posted

Median

95% Confidence Interval

months

End of study (up to 39 months)

ID	Title	Description
OG000	Nilotinib	400 mg twice daily
OG001	DTIC	850 mg/m2 IV every 3 weeks

Units	Counts
Participants	OG000

Secondary

Disease Control Rate (DCR)

DCR was defined as the proportion of participants with an overall response of CR of any duration, PR of any duration, or stable disease (SD) for a minimum of 12 weeks from start of treatment. Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions; PD, a >=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; SD: no change or small changes that do not meet previously given criteria for CR, PR or PD.

Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.

Posted

Number

Participants

End of study (up to 39 months)

ID	Title	Description
OG000	Nilotinib	400 mg twice daily
OG001	DTIC	850 mg/m2 IV every 3 weeks

Units	Counts
Participants

Secondary

PFS Rate

Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.

Posted

Number

Percentage of participants

End of study (up to 39 months)

ID	Title	Description
OG000	Nilotinib	400 mg twice daily
OG001	DTIC	850 mg/m2 IV every 3 weeks

Units	Counts
Participants	OG000

Secondary

OS Rate

OS was defined as the time from the date of the start of treatment to the date of death due to any cause.

Full analysis set (FAS): The FAS included all participants to whom treatment was assigned.

Posted

Number

Percentage of participants

End of study (up to 39 months)

ID	Title	Description
OG000	Nilotinib	400 mg twice daily
OG001	DTIC	850 mg/m2 IV every 3 weeks

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Arrhythmia	Cardiac disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Myocardial infarction	Cardiac disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Retinal detachment	Eye disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Visual impairment	Eye disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Abdominal pain	Gastrointestinal disorders	17.1	Systematic Assessment	EG0002 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Abdominal pain upper	Gastrointestinal disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Ascites	Gastrointestinal disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Nausea	Gastrointestinal disorders	17.1	Systematic Assessment	EG0003 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Vomiting	Gastrointestinal disorders	17.1	Systematic Assessment	EG0003 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Asthenia	General disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Fatigue	General disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
General physical health deterioration	General disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Malaise	General disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Oedema peripheral	General disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Herpes zoster cutaneous disseminated	Infections and infestations	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Infection	Infections and infestations	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Lower respiratory tract infection	Infections and infestations	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Pneumonia	Infections and infestations	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Ankle fracture	Injury, poisoning and procedural complications	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Joint dislocation	Injury, poisoning and procedural complications	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Amylase increased	Investigations	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Blood creatinine increased	Investigations	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Lipase increased	Investigations	17.1	Systematic Assessment	EG0002 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Dehydration	Metabolism and nutrition disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Hyperglycaemia	Metabolism and nutrition disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Dizziness	Nervous system disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Epilepsy	Nervous system disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Haematuria	Renal and urinary disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	17.1	Systematic Assessment	EG0005 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Leukopenia	Blood and lymphatic system disorders	17.1	Systematic Assessment	EG0003 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Lymphopenia	Blood and lymphatic system disorders	17.1	Systematic Assessment	EG0003 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Neutropenia	Blood and lymphatic system disorders	17.1	Systematic Assessment	EG0002 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Thrombocytopenia	Blood and lymphatic system disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Sinus bradycardia	Cardiac disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Otorrhoea	Ear and labyrinth disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Vertigo	Ear and labyrinth disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Eye pruritus	Eye disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Lacrimation increased	Eye disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Vision blurred	Eye disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Abdominal distension	Gastrointestinal disorders	17.1	Systematic Assessment	EG0003 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Abdominal pain upper	Gastrointestinal disorders	17.1	Systematic Assessment	EG0004 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Constipation	Gastrointestinal disorders	17.1	Systematic Assessment	EG0009 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Diarrhoea	Gastrointestinal disorders	17.1	Systematic Assessment	EG0007 affected42 at risk EG0011 affected13 at risk EG0023 affected10 at risk
Dyspepsia	Gastrointestinal disorders	17.1	Systematic Assessment	EG0003 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Nausea	Gastrointestinal disorders	17.1	Systematic Assessment	EG00018 affected42 at risk EG0015 affected13 at risk EG0022 affected10 at risk
Odynophagia	Gastrointestinal disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0011 affected13 at risk EG0021 affected10 at risk
Oral discomfort	Gastrointestinal disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Oral pain	Gastrointestinal disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Tongue ulceration	Gastrointestinal disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Toothache	Gastrointestinal disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Vomiting	Gastrointestinal disorders	17.1	Systematic Assessment	EG00011 affected42 at risk EG0011 affected13 at risk EG0021 affected10 at risk
Asthenia	General disorders	17.1	Systematic Assessment	EG0002 affected42 at risk EG0011 affected13 at risk EG0023 affected10 at risk
Chills	General disorders	17.1	Systematic Assessment	EG0003 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Fatigue	General disorders	17.1	Systematic Assessment	EG00013 affected42 at risk EG0015 affected13 at risk EG0024 affected10 at risk
Feeling cold	General disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
General physical health deterioration	General disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Oedema peripheral	General disorders	17.1	Systematic Assessment	EG0003 affected42 at risk EG0011 affected13 at risk EG0022 affected10 at risk
Pain	General disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Pyrexia	General disorders	17.1	Systematic Assessment	EG0003 affected42 at risk EG0013 affected13 at risk EG0022 affected10 at risk
Suprapubic pain	General disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Temperature intolerance	General disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Ulcer haemorrhage	General disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Conjunctivitis	Infections and infestations	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Ear infection	Infections and infestations	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Erysipelas	Infections and infestations	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Gastrointestinal infection	Infections and infestations	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0021 affected10 at risk
Gingivitis	Infections and infestations	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Herpes zoster	Infections and infestations	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Influenza	Infections and infestations	17.1	Systematic Assessment	EG0002 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Nasopharyngitis	Infections and infestations	17.1	Systematic Assessment	EG0003 affected42 at risk EG0012 affected13 at risk EG0022 affected10 at risk
Oral fungal infection	Infections and infestations	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Oral herpes	Infections and infestations	17.1	Systematic Assessment	EG0001 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Pneumonia	Infections and infestations	17.1	Systematic Assessment	EG0001 affected42 at risk EG0011 affected13 at risk EG0021 affected10 at risk
Sinusitis	Infections and infestations	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Staphylococcal infection	Infections and infestations	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Tooth infection	Infections and infestations	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Upper respiratory tract infection	Infections and infestations	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Urinary tract infection	Infections and infestations	17.1	Systematic Assessment	EG0003 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Fall	Injury, poisoning and procedural complications	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Wound	Injury, poisoning and procedural complications	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Alanine aminotransferase increased	Investigations	17.1	Systematic Assessment	EG00010 affected42 at risk EG0011 affected13 at risk EG0021 affected10 at risk
Amylase increased	Investigations	17.1	Systematic Assessment	EG0008 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Aspartate aminotransferase increased	Investigations	17.1	Systematic Assessment	EG0008 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Bilirubin conjugated increased	Investigations	17.1	Systematic Assessment	EG00011 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Blood alkaline phosphatase increased	Investigations	17.1	Systematic Assessment	EG0005 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Blood bilirubin increased	Investigations	17.1	Systematic Assessment	EG00019 affected42 at risk EG0011 affected13 at risk EG0023 affected10 at risk
Blood bilirubin unconjugated increased	Investigations	17.1	Systematic Assessment	EG0009 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Blood cholesterol increased	Investigations	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Blood creatinine increased	Investigations	17.1	Systematic Assessment	EG0002 affected42 at risk EG0010 affected13 at risk EG0022 affected10 at risk
Blood lactate dehydrogenase increased	Investigations	17.1	Systematic Assessment	EG0004 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Blood phosphorus decreased	Investigations	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Blood pressure decreased	Investigations	17.1	Systematic Assessment	EG0004 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Blood pressure increased	Investigations	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0021 affected10 at risk
Gamma-glutamyltransferase increased	Investigations	17.1	Systematic Assessment	EG00011 affected42 at risk EG0011 affected13 at risk EG0021 affected10 at risk
Haemoglobin decreased	Investigations	17.1	Systematic Assessment	EG0002 affected42 at risk EG0010 affected13 at risk EG0022 affected10 at risk
Lipase increased	Investigations	17.1	Systematic Assessment	EG0008 affected42 at risk EG0011 affected13 at risk EG0022 affected10 at risk
Low density lipoprotein increased	Investigations	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Neutrophil count decreased	Investigations	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Platelet count decreased	Investigations	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Total bile acids increased	Investigations	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Decreased appetite	Metabolism and nutrition disorders	17.1	Systematic Assessment	EG00013 affected42 at risk EG0012 affected13 at risk EG0023 affected10 at risk
Dehydration	Metabolism and nutrition disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	17.1	Systematic Assessment	EG0004 affected42 at risk EG0011 affected13 at risk EG0021 affected10 at risk
Hyperglycaemia	Metabolism and nutrition disorders	17.1	Systematic Assessment	EG0009 affected42 at risk EG0011 affected13 at risk EG0023 affected10 at risk
Hyperkalaemia	Metabolism and nutrition disorders	17.1	Systematic Assessment	EG0003 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	17.1	Systematic Assessment	EG0002 affected42 at risk EG0011 affected13 at risk EG0022 affected10 at risk
Hyperuricaemia	Metabolism and nutrition disorders	17.1	Systematic Assessment	EG0003 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Hypocalcaemia	Metabolism and nutrition disorders	17.1	Systematic Assessment	EG0005 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Hypokalaemia	Metabolism and nutrition disorders	17.1	Systematic Assessment	EG0006 affected42 at risk EG0010 affected13 at risk EG0020 affected10 at risk
Hypophosphataemia	Metabolism and nutrition disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	17.1	Systematic Assessment	EG0004 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Back pain	Musculoskeletal and connective tissue disorders	17.1	Systematic Assessment	EG0002 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Bone pain	Musculoskeletal and connective tissue disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0012 affected13 at risk EG0020 affected10 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Myalgia	Musculoskeletal and connective tissue disorders	17.1	Systematic Assessment	EG0002 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	17.1	Systematic Assessment	EG0005 affected42 at risk EG0012 affected13 at risk EG0022 affected10 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0021 affected10 at risk
Amnesia	Nervous system disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Diabetic neuropathy	Nervous system disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Dizziness	Nervous system disorders	17.1	Systematic Assessment	EG0003 affected42 at risk EG0012 affected13 at risk EG0022 affected10 at risk
Epilepsy	Nervous system disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Headache	Nervous system disorders	17.1	Systematic Assessment	EG0006 affected42 at risk EG0015 affected13 at risk EG0023 affected10 at risk
Hypoaesthesia	Nervous system disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Monoplegia	Nervous system disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Paraesthesia	Nervous system disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Speech disorder	Nervous system disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Anxiety	Psychiatric disorders	17.1	Systematic Assessment	EG0002 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Confusional state	Psychiatric disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Depression	Psychiatric disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Insomnia	Psychiatric disorders	17.1	Systematic Assessment	EG0005 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0011 affected13 at risk EG0021 affected10 at risk
Cough	Respiratory, thoracic and mediastinal disorders	17.1	Systematic Assessment	EG0009 affected42 at risk EG0012 affected13 at risk EG0023 affected10 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	17.1	Systematic Assessment	EG0005 affected42 at risk EG0011 affected13 at risk EG0021 affected10 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0021 affected10 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Alopecia	Skin and subcutaneous tissue disorders	17.1	Systematic Assessment	EG0005 affected42 at risk EG0011 affected13 at risk EG0022 affected10 at risk
Dry skin	Skin and subcutaneous tissue disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Erythema	Skin and subcutaneous tissue disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Night sweats	Skin and subcutaneous tissue disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Pruritus	Skin and subcutaneous tissue disorders	17.1	Systematic Assessment	EG0003 affected42 at risk EG0011 affected13 at risk EG0021 affected10 at risk
Rash	Skin and subcutaneous tissue disorders	17.1	Systematic Assessment	EG00020 affected42 at risk EG0012 affected13 at risk EG0023 affected10 at risk
Skin burning sensation	Skin and subcutaneous tissue disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0010 affected13 at risk EG0021 affected10 at risk
Skin hypopigmentation	Skin and subcutaneous tissue disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0010 affected13 at risk EG0022 affected10 at risk
Hypertension	Vascular disorders	17.1	Systematic Assessment	EG0003 affected42 at risk EG0010 affected13 at risk EG0022 affected10 at risk
Lymphoedema	Vascular disorders	17.1	Systematic Assessment	EG0001 affected42 at risk EG0011 affected13 at risk EG0020 affected10 at risk
Vein disorder	Vascular disorders	17.1	Systematic Assessment	EG0000 affected42 at risk EG0011 affected13 at risk EG0021 affected10 at risk

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009380	Neoplasms, Nerve Tissue
D018326	Nevi and Melanomas
D012878	Skin Neoplasms
D009371	Neoplasms by Site
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D014226	Triazenes
D009930	Organic Chemicals
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Nilotinib	400 mg twice daily
BG001	DTIC	850 mg/m2 IV every 3 weeks
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Nilotinib	400 mg twice daily	12	42	40	42
EG001	DTIC	850 mg/m2 IV every 3 weeks	1	13	9	13
EG002	Crossover Nilotinib Treatment	Crossover nilotinib treatment	4	10	10	10