Trial Outcomes & Findings for BKM120 for Patients With PI3K-activated Tumors (NCT NCT01833169)

NCT ID: NCT01833169

Last Updated: 2018-10-19

Results Overview

Clinical benefit rate for patients with solid tumors will be assessed using RECIST 1.1 and will include responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) at \>=16 weeks. For hematologic tumors other appropriate hematological response criteria was applied. Response criteria: CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm., PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study, PD= At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 146 participants
• Primary outcome timeframe: Week 16
• Results posted on: 2018-10-19

Participant Flow

Prior to informed consent, patient was pre-identified to have activation of the P13K pathway confirmed via Genomic Profiling Report and whose disease had progressed on or after standard treatment

Participant milestones

Measure	BKM120 BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
Overall Study STARTED	146
Overall Study Consented to be Followed for Survival	128
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	146

Reasons for withdrawal

Measure	BKM120 BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
Overall Study Disease Progression	99
Overall Study Adverse Event	33
Overall Study Withdrawal by Subject	9
Overall Study Death	3
Overall Study Physician Decision	2

Baseline Characteristics

BKM120 for Patients With PI3K-activated Tumors

Baseline characteristics by cohort

Measure	BKM120 n=146 Participants BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	95 Participants n=5 Participants
Age, Categorical >=65 years	51 Participants n=5 Participants
Age, Continuous	58.4 years STANDARD_DEVIATION 12.91 • n=5 Participants
Sex: Female, Male Female	85 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	130 participants n=5 Participants
Race/Ethnicity, Customized Black	7 participants n=5 Participants
Race/Ethnicity, Customized Asian	3 participants n=5 Participants
Race/Ethnicity, Customized Other	6 participants n=5 Participants
ECOG Grade Grade 0	54 participants n=5 Participants
ECOG Grade Grade 1	91 participants n=5 Participants
ECOG Grade Grade 2	1 participants n=5 Participants
Protocol pre-defined gene mutation (by local labs) PIK3CA gene mutation	74 participants n=5 Participants
Protocol pre-defined gene mutation (by local labs) PTEN gene mutation	60 participants n=5 Participants
Protocol pre-defined gene mutation (by local labs) PIK3CA amplification	19 participants n=5 Participants
Protocol pre-defined gene mutation (by local labs) PIK3R1 gene mutation	7 participants n=5 Participants
Prior Lines of Antineoplastic Medications	3 Number of prior lines of treatment n=5 Participants

PRIMARY outcome

Timeframe: Week 16

Clinical benefit rate for patients with solid tumors will be assessed using RECIST 1.1 and will include responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) at >=16 weeks. For hematologic tumors other appropriate hematological response criteria was applied. Response criteria: CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm., PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study, PD= At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline

Outcome measures

Measure	BKM120 n=146 Participants BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
Participant Clinical Benefit Response Rate	15.1 percentage of participants Interval 9.7 to 21.9

SECONDARY outcome

Timeframe: baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months

Overall Response (OR) of Partial Response (PR) or greater is based on local investigator assessment. For patients with solid tumors, the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR. For hematologic tumors other appropriate hematological response criteria apply

Outcome measures

Measure	BKM120 n=146 Participants BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
Overall Response of Partial Response (PR) or Greater. PR=at Least a 30% Decrease in the Sum of Diameters of Target Lesions, Taking as Reference the Baseline Sum Diameters	1.4 percentage of patients Interval 0.2 to 4.9

SECONDARY outcome

Timeframe: Every 8 Weeks until death, assessed up to 24 months

Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause

Outcome measures

Measure	BKM120 n=146 Participants BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
Progression-Free Survival - Number of Participants With an Event participants with an event	112 participants
Progression-Free Survival - Number of Participants With an Event participants censored	34 participants

SECONDARY outcome

Timeframe: baseline up to 24 months

Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause

Outcome measures

Measure	BKM120 n=146 Participants BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Timing in Months	1.9 months Interval 1.8 to 2.34

SECONDARY outcome

Timeframe: baseline up to 24 months

Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause.

Outcome measures

Measure	BKM120 n=146 Participants BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Rate in Percentages 1 month	88.4 percentage of participants Interval 81.5 to 92.9
Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Rate in Percentages 2 months	43.8 percentage of participants Interval 34.9 to 52.3
Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Rate in Percentages 3 months	39.4 percentage of participants Interval 30.7 to 47.9
Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Rate in Percentages 4 months	20.4 percentage of participants Interval 13.5 to 28.3
Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Rate in Percentages 5 months	20.4 percentage of participants Interval 13.5 to 28.3
Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Rate in Percentages 6 months	14.1 percentage of participants Interval 8.2 to 21.5
Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Rate in Percentages 9 months	5.8 percentage of participants Interval 2.1 to 12.1
Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Rate in Percentages 12 months	2.9 percentage of participants Interval 0.6 to 8.6
Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Rate in Percentages 18 months	1.4 percentage of participants Interval 0.1 to 6.7
Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Rate in Percentages 24 months	0.0 percentage of participants confidence interval could not be determined because 0 patients had an event

SECONDARY outcome

Timeframe: Every 8 Weeks until death, assessed up to 24 months

Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact

Outcome measures

Measure	BKM120 n=146 Participants BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
Overall Survival - Number of Participants With an Event participants with an event	110 participants
Overall Survival - Number of Participants With an Event participants censored	36 participants

SECONDARY outcome

Timeframe: baseline up to 24 months

Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact

Outcome measures

Measure	BKM120 n=146 Participants BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
Overall Survival (OS)- Kaplan-Meier Estimates of OS Timing in Months	6.3 months Interval 5.2 to 8.8

SECONDARY outcome

Timeframe: baseline up to 30 months

Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact

Outcome measures

Measure	BKM120 n=146 Participants BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28- day cycle
Overall Survival (OS)- Kaplan-Meier Estimates of OS Rate in Percentages 1 month	97.3 percentage of participants Interval 92.8 to 99.0
Overall Survival (OS)- Kaplan-Meier Estimates of OS Rate in Percentages 2 months	83.4 percentage of participants Interval 76.2 to 88.5
Overall Survival (OS)- Kaplan-Meier Estimates of OS Rate in Percentages 3 months	73.5 percentage of participants Interval 65.5 to 80.0
Overall Survival (OS)- Kaplan-Meier Estimates of OS Rate in Percentages 30 months	12.2 percentage of participants Interval 5.0 to 22.7
Overall Survival (OS)- Kaplan-Meier Estimates of OS Rate in Percentages 4 months	61.5 percentage of participants Interval 53.0 to 68.9
Overall Survival (OS)- Kaplan-Meier Estimates of OS Rate in Percentages 5 months	60.1 percentage of participants Interval 51.6 to 67.6
Overall Survival (OS)- Kaplan-Meier Estimates of OS Rate in Percentages 6 months	51.5 percentage of participants Interval 43.0 to 59.4
Overall Survival (OS)- Kaplan-Meier Estimates of OS Rate in Percentages 9 months	41.3 percentage of participants Interval 33.2 to 49.3
Overall Survival (OS)- Kaplan-Meier Estimates of OS Rate in Percentages 12 months	30.2 percentage of participants Interval 22.6 to 38.1
Overall Survival (OS)- Kaplan-Meier Estimates of OS Rate in Percentages 18 months	18.6 percentage of participants Interval 11.9 to 26.4
Overall Survival (OS)- Kaplan-Meier Estimates of OS Rate in Percentages 24 months	12.2 percentage of participants Interval 5.0 to 22.7

Adverse Events

BKM120

Serious events: 59 serious events

Other events: 141 other events

Deaths: 0 deaths

Serious adverse events

Measure	BKM120 n=146 participants at risk BKM120
Psychiatric disorders Mental status changes	2.7% 4/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Psychiatric disorders Psychotic disorder	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Renal and urinary disorders Acute kidney injury	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Renal and urinary disorders Haematuria	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Renal and urinary disorders Hydronephrosis	2.1% 3/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Blood and lymphatic system disorders Anaemia	1.4% 2/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Blood and lymphatic system disorders Anaemia of malignant disease	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Blood and lymphatic system disorders Leukocytosis	2.1% 3/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Blood and lymphatic system disorders Thrombocytopenia	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders Acute myocardial infarction	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders Cardio-respiratory arrest	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders Sinus tachycardia	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Cardiac disorders Tachycardia	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders Abdominal pain	5.5% 8/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders Abdominal pain lower	1.4% 2/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders Abdominal pain upper	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders Ascites	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders Diarrhoea	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders Dysphagia	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders Intestinal obstruction	1.4% 2/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders Intestinal perforation	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders Nausea	4.8% 7/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders Oesophageal perforation	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders Pancreatitis	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders Small intestinal obstruction	2.1% 3/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders Vomiting	5.5% 8/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
General disorders Chest pain	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
General disorders Fatigue	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
General disorders Oedema	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
General disorders Oedema peripheral	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
General disorders Pain	1.4% 2/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
General disorders Pyrexia	2.1% 3/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations Bacteraemia	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations Catheter site infection	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations Klebsiella infection	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations Liver abscess	1.4% 2/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations Pelvic abscess	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations Pneumonia	3.4% 5/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations Sepsis	2.1% 3/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations Urinary tract infection	1.4% 2/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations Urinary tract infection bacterial	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Investigations Alanine aminotransferase increased	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Investigations Ammonia increased	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Investigations Aspartate aminotransferase increased	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Investigations Blood alkaline phosphatase increased	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Investigations Blood bilirubin increased	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Metabolism and nutrition disorders Cachexia	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Metabolism and nutrition disorders Dehydration	2.7% 4/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Metabolism and nutrition disorders Failure to thrive	2.1% 3/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Metabolism and nutrition disorders Hypercalcaemia	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Metabolism and nutrition disorders Hyperglycaemia	1.4% 2/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Metabolism and nutrition disorders Hyperkalaemia	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Metabolism and nutrition disorders Hypocalcaemia	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Metabolism and nutrition disorders Hypokalaemia	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Metabolism and nutrition disorders Hyponatraemia	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Metabolism and nutrition disorders Hypophagia	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Metabolism and nutrition disorders Lactic acidosis	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Metabolism and nutrition disorders Metabolic acidosis	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Musculoskeletal and connective tissue disorders Flank pain	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Musculoskeletal and connective tissue disorders Soft tissue haemorrhage	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Nervous system disorders Altered state of consciousness	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Nervous system disorders Encephalopathy	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Nervous system disorders Leukoencephalopathy	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Nervous system disorders Peroneal nerve palsy	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Nervous system disorders Seizure	1.4% 2/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Nervous system disorders Spinal cord compression	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Nervous system disorders Subarachnoid haemorrhage	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Nervous system disorders Syncope	1.4% 2/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Psychiatric disorders Anxiety	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Psychiatric disorders Confusional state	1.4% 2/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Psychiatric disorders Depression	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Respiratory, thoracic and mediastinal disorders Apnoea	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.8% 7/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.1% 3/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.4% 2/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Skin and subcutaneous tissue disorders Erythema	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Skin and subcutaneous tissue disorders Psoriasis	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Skin and subcutaneous tissue disorders Rash	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Vascular disorders Shock haemorrhagic	0.68% 1/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.

Other adverse events

Measure	BKM120 n=146 participants at risk BKM120
Blood and lymphatic system disorders Anaemia	11.0% 16/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders Abdominal pain	11.0% 16/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders Abdominal pain upper	6.8% 10/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders Constipation	15.1% 22/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders Diarrhoea	34.9% 51/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders Dry mouth	6.2% 9/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders Dyspepsia	9.6% 14/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders Nausea	45.2% 66/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Gastrointestinal disorders Vomiting	27.4% 40/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
General disorders Fatigue	49.3% 72/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
General disorders Mucosal inflammation	7.5% 11/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
General disorders Oedema peripheral	9.6% 14/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Infections and infestations Urinary tract infection	8.2% 12/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Investigations Alanine aminotransferase increased	18.5% 27/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Investigations Aspartate aminotransferase increased	24.0% 35/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Investigations Blood alkaline phosphatase increased	6.8% 10/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Investigations Blood bilirubin increased	8.2% 12/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Investigations Gamma-glutamyltransferase increased	6.2% 9/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Investigations Lipase increased	6.2% 9/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Investigations Weight decreased	24.0% 35/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Metabolism and nutrition disorders Decreased appetite	39.7% 58/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Metabolism and nutrition disorders Dehydration	13.0% 19/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Metabolism and nutrition disorders Hyperglycaemia	27.4% 40/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Metabolism and nutrition disorders Hypokalaemia	6.8% 10/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Metabolism and nutrition disorders Hypomagnesaemia	8.2% 12/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Metabolism and nutrition disorders Hyponatraemia	6.8% 10/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Metabolism and nutrition disorders Hypophosphataemia	5.5% 8/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Musculoskeletal and connective tissue disorders Back pain	8.2% 12/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Musculoskeletal and connective tissue disorders Muscular weakness	6.8% 10/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Nervous system disorders Dizziness	8.9% 13/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Nervous system disorders Dysgeusia	10.3% 15/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Nervous system disorders Headache	8.9% 13/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Nervous system disorders Tremor	6.8% 10/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Psychiatric disorders Anxiety	28.1% 41/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Psychiatric disorders Confusional state	8.2% 12/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Psychiatric disorders Depression	28.1% 41/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Psychiatric disorders Insomnia	15.1% 22/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Respiratory, thoracic and mediastinal disorders Cough	14.4% 21/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Respiratory, thoracic and mediastinal disorders Dyspnoea	13.0% 19/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Skin and subcutaneous tissue disorders Dry skin	6.8% 10/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Skin and subcutaneous tissue disorders Pruritus	6.8% 10/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Skin and subcutaneous tissue disorders Rash	16.4% 24/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Vascular disorders Hypertension	6.2% 9/146 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months. Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: Novartis.email@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER