Safety and Efficacy of BKM120 in Patients With Metastatic... | NCT01297491

ID	Type	Description	Link
2010-024011-14	EudraCT Number

Label	Type	Description	Intervention Names
Squamous BKM120 100mg qd	Experimental	Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.	Drug: BKM120
Non-Squamous BKM120 100mg qd	Experimental	Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.	Drug: BKM120

Name	Type	Description	Arm Group Labels	Other Names
BKM120	Drug	Buparlisib was supplied as 10mg or 50mg capsules. It was administered on a continuous once daily dosing schedule at a dose of 100 mg. The patient was dosed on a flat scale of mg/day and not adjusted to body weight or body surface area.

Measure	Description	Time Frame
Progression Free Survival (PFS) Rate as Per Investigator Local Review Measured Using RECIST 1.1 of Patients at Week 12	PFS rate was defined as the percentage of participants who were progression free at 12 weeks. Participants were considered as a "success" for PFS rate evaluated at 12 weeks if they presented an overall response at their 2nd post-baseline tumor assessment.The enrollment into the study in either histology group would stop for futility if a PFS rate <50% at 12 weeks was observed. No statistical analysis was planned for this primary outcome. The results of the primary objective was based on the data from the interim analysis that took place at the cut off dates: 10-Apr-2013 for non-squamous and 08-Jan-2014 for squamous group.	Week 12

Measure	Description	Time Frame
Overall Survival (OS) Using Kaplan-Meier Estimates	OS was defined as the time from start of study drug (Stage 1) until death from any cause. If a patient was not known to have died, survival was censored at the date of last contact.	Every 8 weeks up to 24 months
Overall Response Rate (ORR) Based on Investigator Assessment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed NSCLC with activated PI3K pathway
Progressive disease after prior systemic antineoplastic treatment(s) for advanced NSCLC
Archival or fresh tumor biopsy must be available for profiling
Measurable and/or non-measurable disease as per RECIST 1.1 criteria
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Adequate organ function as assessed by laboratory tests

Exclusion Criteria:

Patient has received previous treatment with PI3K inhibitors
Patient with squamous NSCLC has received more than one line of chemotherapy treatment for metastatic disease; patient with non-squamous NSCLC has received more than two lines of systemic antineoplastic treatment for metastatic disease
Uncontrolled or symptomatic CNS metastases
Concurrent use of any other approved or investigational antineoplastic agent
Radiotherapy ≤ 28 days prior to starting study drug
Major surgery within 28 days prior to starting study drug
History of clinically significant cardiac dysfunction, mood disorders, or poorly controlled diabetes mellitus
Current treatment with medication that has a known risk to prolong the QT interval or inducing Torsades de Pointes
Impairment of gastrointestinal (GI) function
Chronic treatment with steroids or another immunosuppressive agent.
Concurrent severe and/or uncontrolled medical condition
Currently receiving Warfarin or another coumarin derivative
Known history of HIV infection
Sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality)
Pregnancy, lactation, or breastfeeding
Woman of child-bearing potential

Other protocol-defined inclusion/exclusion criteria may apply

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Ironwood Cancer and Research Centers SC		Chandler	Arizona	85224	United States
Arizona Oncology Associates Tucson (Rudasill & La Cholla)

PubMed Identifier	Type	Citation	Retractions
26098748	Result	Vansteenkiste JF, Canon JL, De Braud F, Grossi F, De Pas T, Gray JE, Su WC, Felip E, Yoshioka H, Gridelli C, Dy GK, Thongprasert S, Reck M, Aimone P, Vidam GA, Roussou P, Wang YA, Di Tomaso E, Soria JC. Safety and Efficacy of Buparlisib (BKM120) in Patients with PI3K Pathway-Activated Non-Small Cell Lung Cancer: Results from the Phase II BASALT-1 Study. J Thorac Oncol. 2015 Sep;10(9):1319-1327. doi: 10.1097/JTO.0000000000000607.

ID	Title	Description
FG000	Squamous BKM120 100mg qd	Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
FG001	Non-Squamous BKM120 100mg qd

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

Progression Free Survival (PFS) Rate as Per Investigator Local Review Measured Using RECIST 1.1 of Patients at Week 12

PFS rate was defined as the percentage of participants who were progression free at 12 weeks. Participants were considered as a "success" for PFS rate evaluated at 12 weeks if they presented an overall response at their 2nd post-baseline tumor assessment.The enrollment into the study in either histology group would stop for futility if a PFS rate <50% at 12 weeks was observed.

No statistical analysis was planned for this primary outcome. The results of the primary objective was based on the data from the interim analysis that took place at the cut off dates: 10-Apr-2013 for non-squamous and 08-Jan-2014 for squamous group.

Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.

Posted

Number

95% Confidence Interval

Percentage of participants

Week 12

ID	Title	Description
OG000	Squamous BKM120 100mg qd	Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
OG001	Non-Squamous BKM120 100mg qd	Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.

Units	Counts
Participants	OG00030 OG00130

Title

Denominators

Categories

Title	Measurements
	OG00023.3(9.9 to 42.3) OG00120.0(7.7 to 38.6)

Secondary

Overall Survival (OS) Using Kaplan-Meier Estimates

OS was defined as the time from start of study drug (Stage 1) until death from any cause. If a patient was not known to have died, survival was censored at the date of last contact.

Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.

Posted

Median

95% Confidence Interval

Months

Every 8 weeks up to 24 months

ID	Title	Description
OG000	Squamous BKM120 100mg qd	Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
OG001	Non-Squamous BKM120 100mg qd	Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.

Units	Counts
Participants	OG000

Secondary

Overall Response Rate (ORR) Based on Investigator Assessment

ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR). Complete response was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. Partial response was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Analyses of response rates were performed based on investigators' assessments (as per RECIST 1.1 criteria). ORR included all patients with and without measurable disease at baseline.

Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.

Posted

Number

Percentage of participants

Every 6 weeks up to 24 months

ID	Title	Description
OG000	Squamous BKM120 100mg qd	Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
OG001	Non-Squamous BKM120 100mg qd	Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.

Secondary

Disease Control Rate (DCR)

DCR defined as the percentage of participants with best overall response of CR or PR or stable disease (SD). Complete response was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. Partial response was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.

Analyses of response rates were performed based on investigators' assessments (as per RECIST 1.1 criteria). DCR included all participants with and without measurable disease at baseline.

Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least one dose of study drug.

Posted

Number

Percentage of participants

Every 6 weeks up tp 24 months

ID	Title	Description
OG000	Squamous BKM120 100mg qd	Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
OG001	Non-Squamous BKM120 100mg qd	Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.

Secondary

Time to Response (TTR)

TTR for a participant was defined as the time from the first treatment date to the date of first documented confirmed CR or PR evaluation. The date of event was defined as the date of response that was first determined and not using the date the response was confirmed.

Analysis set Stage 1 includes all patients who were enrolled during Stage 1 after meeting eligibility criteria and who have received at least 1 dose of study drug. 1 partial response was observed as best overall response (BOR) for 1 patient in the squamous group. Also,1 patient experienced partial response as BOR in the non-squamous group.

Posted

Number

Days

Every 6 weeks up to 24 months

ID	Title	Description
OG000	Squamous BKM120 100mg qd	Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
OG001	Non-Squamous BKM120 100mg qd	Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.

Units	Counts
Participants

Secondary

Duration of Response (DoR)

DoR was defined as the elapsed time between the date of first documented CR or PR response (not the date of confirmed response) and the following date of event defined as the first documented progression or death due to underlying cancer.

Posted

Number

Days

Every 6 weeks up to 24 months

ID	Title	Description
OG000	Squamous BKM120 100mg qd	Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
OG001	Non-Squamous BKM120 100mg qd	Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Cardiac failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Cardiogenic shock	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected30 at risk EG0011 affected33 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Blepharitis	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected30 at risk EG0011 affected33 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected30 at risk EG0011 affected33 at risk
Enteritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected30 at risk EG0011 affected33 at risk
Ileus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0000 affected30 at risk EG0011 affected33 at risk
General physical health deterioration	General disorders	MedDRA	Systematic Assessment	EG0004 affected30 at risk EG0010 affected33 at risk
Local swelling	General disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected30 at risk EG0011 affected33 at risk
Escherichia sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected30 at risk EG0011 affected33 at risk
Lung abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected30 at risk EG0011 affected33 at risk
Lung infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected30 at risk EG0011 affected33 at risk
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected30 at risk EG0011 affected33 at risk
Urinary tract infection pseudomonal	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Alanine aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Aspartate aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0010 affected33 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0013 affected33 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected30 at risk EG0011 affected33 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0013 affected33 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected30 at risk EG0011 affected33 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0011 affected33 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected30 at risk EG0013 affected33 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0010 affected33 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0011 affected33 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected30 at risk EG0011 affected33 at risk
Thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected30 at risk EG0011 affected33 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0005 affected30 at risk EG0012 affected33 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0010 affected33 at risk
Sinus tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0010 affected33 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected30 at risk EG0012 affected33 at risk
Lacrimation increased	Eye disorders	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0011 affected33 at risk
Vision blurred	Eye disorders	MedDRA	Systematic Assessment	EG0003 affected30 at risk EG0012 affected33 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected30 at risk EG0011 affected33 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0005 affected30 at risk EG0013 affected33 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00011 affected30 at risk EG00111 affected33 at risk
Dry mouth	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0011 affected33 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0010 affected33 at risk
Dysphagia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0012 affected33 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00013 affected30 at risk EG0019 affected33 at risk
Stomatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0014 affected33 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0006 affected30 at risk EG0015 affected33 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0006 affected30 at risk EG00112 affected33 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG00011 affected30 at risk EG0016 affected33 at risk
Hypothermia	General disorders	MedDRA	Systematic Assessment	EG0000 affected30 at risk EG0012 affected33 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0003 affected30 at risk EG0011 affected33 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0003 affected30 at risk EG0011 affected33 at risk
Pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0012 affected33 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0014 affected33 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected30 at risk EG0010 affected33 at risk
Candida infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0010 affected33 at risk
Conjunctivitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0013 affected33 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0010 affected33 at risk
Rhinitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected30 at risk EG0012 affected33 at risk
Alanine aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG0006 affected30 at risk EG0016 affected33 at risk
Aspartate aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG0005 affected30 at risk EG0016 affected33 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA	Systematic Assessment	EG0003 affected30 at risk EG0011 affected33 at risk
Blood creatinine increased	Investigations	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0011 affected33 at risk
Blood glucose increased	Investigations	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0011 affected33 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0012 affected33 at risk
Blood urea increased	Investigations	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0010 affected33 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA	Systematic Assessment	EG0003 affected30 at risk EG0012 affected33 at risk
Insulin c-peptide increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected30 at risk EG0012 affected33 at risk
Transaminases increased	Investigations	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0012 affected33 at risk
Weight decreased	Investigations	MedDRA	Systematic Assessment	EG0008 affected30 at risk EG0013 affected33 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00011 affected30 at risk EG00112 affected33 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0010 affected33 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00011 affected30 at risk EG00111 affected33 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0012 affected33 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0010 affected33 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected30 at risk EG0013 affected33 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0010 affected33 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0012 affected33 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected30 at risk EG0011 affected33 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0012 affected33 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0012 affected33 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0010 affected33 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0013 affected33 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0011 affected33 at risk
Dysgeusia	Nervous system disorders	MedDRA	Systematic Assessment	EG0004 affected30 at risk EG0014 affected33 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0004 affected30 at risk EG0010 affected33 at risk
Memory impairment	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0010 affected33 at risk
Myoclonus	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0010 affected33 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0012 affected33 at risk
Somnolence	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0012 affected33 at risk
Tremor	Nervous system disorders	MedDRA	Systematic Assessment	EG0004 affected30 at risk EG0011 affected33 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0003 affected30 at risk EG0018 affected33 at risk
Confusional state	Psychiatric disorders	MedDRA	Systematic Assessment	EG0003 affected30 at risk EG0011 affected33 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0004 affected30 at risk EG00111 affected33 at risk
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0012 affected33 at risk
Mood altered	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0014 affected33 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 affected30 at risk EG0010 affected33 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0006 affected30 at risk EG0016 affected33 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0006 affected30 at risk EG0017 affected33 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0012 affected33 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected30 at risk EG0010 affected33 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0012 affected33 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected30 at risk EG0012 affected33 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0012 affected33 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0004 affected30 at risk EG0015 affected33 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected30 at risk EG0013 affected33 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0012 affected33 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00011 affected30 at risk EG0014 affected33 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0008 affected30 at risk EG0016 affected33 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0012 affected33 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected30 at risk EG0012 affected33 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected30 at risk EG0012 affected33 at risk

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Title	Description
BG000	Squamous BKM120 100mg qd	Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
BG001	Non-Squamous BKM120 100mg qd	Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
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	Squamous BKM120 100 mg qd	Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.			16	30	29	30
EG001	Non-Squamous BKM120 100 mg qd	Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.			15	33	32	33