Clinical Study of BYM338 for the Treatment of Unintention... | NCT01433263 | Trialant
NCT01433263
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Mar 2, 2016Estimated
Enrollment
57Actual
Phase
Phase 2
Conditions
Cachexia
Interventions
BYM338 active drug
Placebo
Countries
United States
Lithuania
Romania
Switzerland
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01433263
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CBYM338X2202
Secondary IDs
Not provided
Brief Title
Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas
Official Title
A Randomized, Double-blind, Placebo-controlled Multi-center Study of BYM338 for Treatment of Cachexia in Patients With Stage IV Non-small Cell Lung Cancer or Stage III/IV Adenocarcinoma of the Pancreas
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Feb 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2011
Primary Completion Date
Apr 2014Actual
Completion Date
Apr 2014Actual
First Submitted Date
Aug 24, 2011
First Submission Date that Met QC Criteria
Sep 9, 2011
First Posted Date
Sep 13, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 24, 2015
Results First Submitted that Met QC Criteria
Apr 24, 2015
Results First Posted Date
May 13, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 2, 2016
Last Update Posted Date
Mar 2, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
A safety & efficacy clinical study of the investigational medicinal product BYM338 for the treatment of unintentional weight loss in patients with cancer of the lung or the pancreas
Detailed Description
Not provided
Conditions Module
Conditions
Cachexia
Keywords
Wasting syndrome
emaciation
lung cancer
adenocarcinoma
pancreatic cancer
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
57Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
30mg/kg BYM338
Experimental
Drug: BYM338 active drug
Placebo / late 30mg/kg BYM338
Placebo Comparator
Drug: BYM338 active drug
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BYM338 active drug
Drug
30mg/kg BYM338
Placebo / late 30mg/kg BYM338
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8
Thigh Muscle Volume (TMV) change was evaluated by a responder analysis. Patients whose loss of muscle TMV by MRI was no more than or equal to 2% at Week 8 was considered responders.
Baseline, week 8
Secondary Outcomes
Measure
Description
Time Frame
Percentage Change in Body Weight From Baseline at Week 7 and Week 9
Percentage Change in body weight from baseline in killograms (kg) at week 7 and week 9
Baseline, Week 7 and Week 9
Maximum Observed Serum Concentration (Cmax)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion criteria:
Patients must sign an informed consent before assessment
Patients with pathologically and/or clinically confirmed diagnosis of stage IV non-small (squamous or non-squamous) cell lung cancer (NSCLC) or stage III/IV adenocarcinoma of the pancreas.
Patients with stage IV NSCLC will be receiving or completed or discontinued standard chemotherapy or be chemotherapy-naive by choice.
Patients with stage III/IV pancreatic adenocarcinoma will be receiving standard chemotherapy or no chemotherapy. If patients are receiving chemotherapy, a change in chemotherapy is not expected.
Greater than or equal to 5% unintentional weight loss over the previous 3-6 months, not explained by simple starvation. Simple starvation is considered to be excluded when weight loss is not ameliorated by standard nutritional counseling and oral supplementation over a 2 week period.
Body mass index (BMI) ≤ 30 kg/m2.
Life expectancy of at least 4 months.
Able to communicate well and comply with the requirements of the study, including by phone and written logs.
Key Exclusion criteria:
Patients who have received investigational anti-neoplastic therapy within 3 weeks of screening
Evidence of inadequate organ or brain function, as defined by lab tests and imaging
Patients with severe and/or uncontrolled medical conditions that could interfere with the study (e.g. heart conditions, high blood pressure, diabetes, infection) uncontrolled pain or any other non-stable illness
Pregnant or lactating women.
Women capable of becoming pregnant must use highly effective contraception during the study and for 8 weeks after stopping treatment. All female patients must have negative pregnancy test results throughout the study
Patients unwilling or unable to follow instructions.
Other protocol-defined inclusion/exclusion criteria may apply.
Epstein SA, Doles JD, Dasgupta A. KLF10: a point of convergence in cancer cachexia. Curr Opin Support Palliat Care. 2024 Sep 1;18(3):120-125. doi: 10.1097/SPC.0000000000000711. Epub 2024 Jul 15.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Core Phase single dose BYM338 30mg/kg i.v. active or placebo with 8week followup. Followup phase started Week 8 & patients on placebo in the Core Phase were given BYM338 & patients on BYM338 in Core Phase continued to be followed for an additional 8 weeks. Late BYM338 are patients who received Placebo during Core Phase and then BYM338 after Week 8.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
30mg/kg BYM338
FG001
Placebo / Late 30mg/kg BYM338
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug
Placebo / late 30mg/kg BYM338
Blood samples for pharmacokinetic (PK) evaluation were drawn on Day 1 30mg/kg BYM338 (Core)or week 8 Late 30mg/kg BYM338 (when placebo subjects were rolled over to active). PK parameters were calculated from plasma concentration-time data using non-compartmental methods.
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8
Time to Reach the Maximum Concentration After Drug Administration (Tmax)
Blood samples for pharmacokinetic (PK) evaluation were drawn on Day 1 30mg/kg BYM338 (Core)or week 8 Late 30mg/kg BYM338 (when placebo subjects were rolled over to active). Tmax was directly determined from the raw serum concentration-time data.
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8
Percentage Change From Baseline in Total Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo: at Week 8
total lean body mass (LBM) is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(LBM at Visit - LBM at Baseline) / LBM at Baseline] * 100.
Baseline, Week 8
Percentage Change From Baseline of Bone Mineral Density (BMD) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo at Week 8
Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.
Baseline, Week 8
Percentage Change From Baseline of Physical Activity Levels (Using the ActivPALâ„¢ Device) Number of Steps Taken Compared to Placebo at Week 4 and 7
Each patient was required to wear the ActivPalâ„¢ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPalâ„¢ was given to patients in clinic to wear for 6 consecutive days. The ActivPALâ„¢ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.
Baseline, Week 4 and Week 7
Percentage Change From Baseline of Physical Activity Levels (Using the ActivPALâ„¢ Device) Time Sedentary Taken Compared to Placebo at Week 4 and 7
Each patient was required to wear the ActivPalâ„¢ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPalâ„¢ was given to patients in clinic to wear for 6 consecutive days. The ActivPALâ„¢ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.
Baseline, Week 4 and Week 7
Percentage Change From Baseline of Physical Activity Levels (Using the ActivPALâ„¢ Device) Time Standing Compared to Placebo at Week 4 and 7
Each patient was required to wear the ActivPalâ„¢ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPalâ„¢ was given to patients in clinic to wear for 6 consecutive days. The ActivPALâ„¢ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.
Baseline, Week 4 and Week 7
Percentage Change From Baseline of Physical Activity Levels (Using the ActivPALâ„¢ Device) Time Stepping Compared to Placebo at Week 4 and 7
Each patient was required to wear the ActivPalâ„¢ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPalâ„¢ was given to patients in clinic to wear for 6 consecutive days. The ActivPALâ„¢ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.
Baseline, Week 4 and Week 7
Tampa
Florida
33647
United States
Novartis Investigative Site
Chicago
Illinois
60611-3308
United States
Novartis Investigative Site
Boston
Massachusetts
02114
United States
Novartis Investigative Site
Canton
Ohio
44718
United States
Novartis Investigative Site
San Antonio
Texas
78217
United States
Novartis Investigative Site
Vilnius
LT 08661
Lithuania
Novartis Investigative Site
Bucharest
Sector 5
Romania
Novartis Investigative Site
Sankt Gallen
9007
Switzerland
Novartis Investigative Site
Edinburgh
EH10 5HF
United Kingdom
FG00029 subjects
FG00128 subjects
COMPLETED
FG00010 subjects
FG00116 subjects
NOT COMPLETED
FG00019 subjects
FG00112 subjects
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0011 subjects
Death
FG0005 subjects
FG0013 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
Protocol Deviation
FG0001 subjects
FG0010 subjects
Withdrawal by Subject
FG00010 subjects
FG0017 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
30mg/kg BYM338
BG001
Placebo / Late 30mg/kg BYM338
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00029
BG00128
BG00257
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00062.8± 10.17
BG00161.5± 10.74
BG00262.1± 10.38
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0009
BG0016
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8
Thigh Muscle Volume (TMV) change was evaluated by a responder analysis. Patients whose loss of muscle TMV by MRI was no more than or equal to 2% at Week 8 was considered responders.
Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 8
Posted
Mean
Standard Deviation
Percentage Change of TMV
Baseline, week 8
ID
Title
Description
OG000
30mg/kg BYM338
OG001
Placebo / Late 30mg/kg BYM338
Units
Counts
Participants
OG00015
OG00122
Title
Denominators
Categories
Title
Measurements
OG0002.0± 8.094
OG0010.65± 8.239
Secondary
Percentage Change in Body Weight From Baseline at Week 7 and Week 9
Percentage Change in body weight from baseline in killograms (kg) at week 7 and week 9
Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.
Posted
Mean
Standard Deviation
Percent Change of Weight (kg)
Baseline, Week 7 and Week 9
ID
Title
Description
OG000
30mg/kg BYM338
OG001
Placebo / Late 30mg/kg BYM338
Units
Counts
Participants
OG000
Secondary
Maximum Observed Serum Concentration (Cmax)
Blood samples for pharmacokinetic (PK) evaluation were drawn on Day 1 30mg/kg BYM338 (Core)or week 8 Late 30mg/kg BYM338 (when placebo subjects were rolled over to active). PK parameters were calculated from plasma concentration-time data using non-compartmental methods.
Pharmacokinetics (PK) analysis set: Patients with evaluable PK data.
Posted
Mean
Standard Deviation
ng/ml
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8
ID
Title
Description
OG000
30mg/kg BYM338
OG001
Placebo / Late 30mg/kg BYM338
Units
Counts
Participants
OG000
Secondary
Time to Reach the Maximum Concentration After Drug Administration (Tmax)
Blood samples for pharmacokinetic (PK) evaluation were drawn on Day 1 30mg/kg BYM338 (Core)or week 8 Late 30mg/kg BYM338 (when placebo subjects were rolled over to active). Tmax was directly determined from the raw serum concentration-time data.
Pharmacokinetics (PK) analysis set: Patients with evaluable PK data.
Posted
Median
Inter-Quartile Range
hr
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8
ID
Title
Description
OG000
30mg/kg BYM338
OG001
Placebo / Late 30mg/kg BYM338
Units
Counts
Participants
OG000
Secondary
Percentage Change From Baseline in Total Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo: at Week 8
total lean body mass (LBM) is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(LBM at Visit - LBM at Baseline) / LBM at Baseline] * 100.
Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 8
Posted
Mean
Standard Deviation
Percentage Change in LBM
Baseline, Week 8
ID
Title
Description
OG000
30mg/kg BYM338
OG001
Placebo / Late 30mg/kg BYM338
Units
Counts
Participants
OG000
Secondary
Percentage Change From Baseline of Bone Mineral Density (BMD) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo at Week 8
Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.
Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 8
Posted
Mean
Standard Deviation
Percentage Change in BMD
Baseline, Week 8
ID
Title
Description
OG000
30mg/kg BYM338
OG001
Placebo / Late 30mg/kg BYM338
Units
Counts
Participants
OG000
Secondary
Percentage Change From Baseline of Physical Activity Levels (Using the ActivPALâ„¢ Device) Number of Steps Taken Compared to Placebo at Week 4 and 7
Each patient was required to wear the ActivPalâ„¢ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPalâ„¢ was given to patients in clinic to wear for 6 consecutive days. The ActivPALâ„¢ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.
Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.
Posted
Mean
Standard Deviation
percentage change in number of steps
Baseline, Week 4 and Week 7
ID
Title
Description
OG000
30mg/kg BYM338
OG001
Placebo / Late 30mg/kg BYM338
Units
Counts
Participants
OG000
Secondary
Percentage Change From Baseline of Physical Activity Levels (Using the ActivPALâ„¢ Device) Time Sedentary Taken Compared to Placebo at Week 4 and 7
Each patient was required to wear the ActivPalâ„¢ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPalâ„¢ was given to patients in clinic to wear for 6 consecutive days. The ActivPALâ„¢ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.
Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.
Posted
Mean
Standard Deviation
percentage change in time (minutes)
Baseline, Week 4 and Week 7
ID
Title
Description
OG000
30mg/kg BYM338
OG001
Placebo / Late 30mg/kg BYM338
Units
Counts
Participants
OG000
Secondary
Percentage Change From Baseline of Physical Activity Levels (Using the ActivPALâ„¢ Device) Time Standing Compared to Placebo at Week 4 and 7
Each patient was required to wear the ActivPalâ„¢ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPalâ„¢ was given to patients in clinic to wear for 6 consecutive days. The ActivPALâ„¢ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.
Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.
Posted
Mean
Standard Deviation
percentage change in time (minutes)
Baseline, Week 4 and Week 7
ID
Title
Description
OG000
30mg/kg BYM338
OG001
Placebo / Late 30mg/kg BYM338
Units
Counts
Participants
OG000
Secondary
Percentage Change From Baseline of Physical Activity Levels (Using the ActivPALâ„¢ Device) Time Stepping Compared to Placebo at Week 4 and 7
Each patient was required to wear the ActivPalâ„¢ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPalâ„¢ was given to patients in clinic to wear for 6 consecutive days. The ActivPALâ„¢ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.
Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.
Posted
Mean
Standard Deviation
percentage change in time (minutes)
Baseline, Week 4 and Week 7
ID
Title
Description
OG000
30mg/kg BYM338
OG001
Placebo / Late 30mg/kg BYM338
Units
Counts
Participants
OG000
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Core - 30mg/kg BYM338
Core - 30mg/kg BYM338
18
29
19
29
EG001
Core - Placebo
Core - Placebo
4
28
19
28
EG002
Follow-up - 30mg/kg BYM338
Follow-up - 30mg/kg BYM338
7
19
12
19
EG003
Follow-up - Placebo
Follow-up - Placebo
1
3
2
3
EG004
Follow-up - 30mg/kg BYM338 Late
Follow-up - 30mg/kg BYM338 Late
7
21
13
21
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG0030 affected3 at risk
EG0040 affected21 at risk
Febrile bone marrow aplasia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Diplopia
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected28 at risk
EG0020 affected19 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected28 at risk
EG0020 affected19 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected28 at risk
EG0020 affected19 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Asthenia
General disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Disease progression
General disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected28 at risk
EG0021 affected19 at risk
EG003
Oedema peripheral
General disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Biliary dilatation
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected28 at risk
EG0020 affected19 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Bacterial sepsis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Klebsiella infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Klebsiella sepsis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0003 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0006 affected29 at risk
EG0010 affected28 at risk
EG0023 affected19 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Presyncope
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Syncope
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected28 at risk
EG0020 affected19 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Angiopathy
Vascular disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0004 affected29 at risk
EG0016 affected28 at risk
EG0022 affected19 at risk
EG0031 affected3 at risk
EG0043 affected21 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0003 affected29 at risk
EG0011 affected28 at risk
EG0021 affected19 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0003 affected29 at risk
EG0013 affected28 at risk
EG0022 affected19 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0002 affected29 at risk
EG0012 affected28 at risk
EG0021 affected19 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected29 at risk
EG0013 affected28 at risk
EG0020 affected19 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected29 at risk
EG0011 affected28 at risk
EG0021 affected19 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected29 at risk
EG0011 affected28 at risk
EG0020 affected19 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0005 affected29 at risk
EG0013 affected28 at risk
EG0021 affected19 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected28 at risk
EG0020 affected19 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0005 affected29 at risk
EG0011 affected28 at risk
EG0020 affected19 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0013 affected28 at risk
EG0022 affected19 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0004 affected29 at risk
EG0011 affected28 at risk
EG0020 affected19 at risk
EG003
Asthenia
General disorders
MedDRA
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Fatigue
General disorders
MedDRA
Systematic Assessment
EG0006 affected29 at risk
EG0013 affected28 at risk
EG0024 affected19 at risk
EG003
Oedema peripheral
General disorders
MedDRA
Systematic Assessment
EG0003 affected29 at risk
EG0013 affected28 at risk
EG0021 affected19 at risk
EG003
Pyrexia
General disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0012 affected28 at risk
EG0020 affected19 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Candida infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0012 affected28 at risk
EG0020 affected19 at risk
EG003
Gingival infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Septic shock
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0022 affected19 at risk
EG003
Wound infection staphylococcal
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Amylase increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected28 at risk
EG0021 affected19 at risk
EG003
Liver function test abnormal
Investigations
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Weight decreased
Investigations
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0022 affected19 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0003 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0004 affected29 at risk
EG0011 affected28 at risk
EG0020 affected19 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0002 affected29 at risk
EG0011 affected28 at risk
EG0020 affected19 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0002 affected29 at risk
EG0012 affected28 at risk
EG0020 affected19 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0002 affected29 at risk
EG0011 affected28 at risk
EG0020 affected19 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0003 affected29 at risk
EG0011 affected28 at risk
EG0020 affected19 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0002 affected29 at risk
EG0011 affected28 at risk
EG0021 affected19 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0012 affected28 at risk
EG0021 affected19 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0002 affected29 at risk
EG0011 affected28 at risk
EG0020 affected19 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0003 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Benign neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0012 affected28 at risk
EG0020 affected19 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Myoclonus
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0011 affected28 at risk
EG0020 affected19 at risk
EG003
Tremor
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA
Systematic Assessment
EG0002 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Bladder irritation
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0011 affected28 at risk
EG0021 affected19 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0012 affected28 at risk
EG0020 affected19 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected29 at risk
EG0012 affected28 at risk
EG0020 affected19 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0021 affected19 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA
Systematic Assessment
EG0003 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Hot flush
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected29 at risk
EG0010 affected28 at risk
EG0020 affected19 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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