Study Evaluating SKI-606 (Bosutinib) In Advanced Malignan... | NCT00195260 | Trialant
NCT00195260
Sponsor
Pfizer
Status
Completed
Last Update Posted
Feb 11, 2013Estimated
Enrollment
151Actual
Phase
Phase 1
Conditions
Neoplasms
Interventions
bosutinib
bosutinib
bosutinib
bosutinib
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00195260
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3160A1-100
Secondary IDs
ID
Type
Description
Link
B1871012
Brief Title
Study Evaluating SKI-606 (Bosutinib) In Advanced Malignant Solid Tumors
Official Title
Phase I Dose-Escalation Study Of Oral SKI-606 In Subjects With Advanced Malignant Solid Tumors
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jan 2013
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
Oct 2004
Primary Completion Date
Nov 2007Actual
Completion Date
Nov 2007Actual
First Submitted Date
Sep 12, 2005
First Submission Date that Met QC Criteria
Sep 12, 2005
First Posted Date
Sep 19, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 4, 2012
Results First Submitted that Met QC Criteria
Jan 3, 2013
Results First Posted Date
Feb 11, 2013Estimated
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
Jan 3, 2013
Last Update Posted Date
Feb 11, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
To evaluate the safety and tolerability of oral SKI-606 (bosutinib) administered on a daily schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated dose (MTD) in this subject population.
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasms
Keywords
Solid tumors
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
151Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Dose escalation
Experimental
Dose finding study of monotherapy bosutinib in patients with advanced solid tumors.
Drug: bosutinib
Colorectal Cancer
Experimental
Enroll 30 patients at RP2D to further evaluate safety and efficacy in subgroup population.
Drug: bosutinib
Pancreatic Cancer
Experimental
Enroll 30 patients at RP2D to further evaluate safety and efficacy in subgroup population.
Drug: bosutinib
Non-Small Cell Lung Cancer (NSCLC)
Experimental
Enroll 30 patients at RP2D to further evaluate safety and efficacy in subgroup population.
Drug: bosutinib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
bosutinib
Drug
Dose levels evaluated 50mg, 100mg, 200mg, 300mg, 400mg, 500mg and 600mg. 500mg was identified as MTD, however due to GI toxicities at that dose, 400mg was selected as the RP2D. Drug was administered as long as tolerable and disease under study did not worsen.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose-limiting Toxicities (DLT) in Part 1
DLT included any grade 3 or 4 clinically-evident non-hematologic toxicity, grade 4 neutropenia of greater than or equal to (>=) 7-day duration or with fever >= 38.5 degrees Celsius (febrile neutropenia); grade 4 thrombocytopenia >= 2-day duration or with bleeding requiring platelet transfusion, any clinically-significant grade >= 2 toxicity that requires >=14 days to resolve (to less than or equal to [=<] grade 1) which occurred in first 21 days of study and considered at least possibly related to bosutinib.
Part 1 Baseline up to Day 28
Number of Participants With Adverse Events (AEs) by Seriousness
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.
Baseline up to 30 days after last dose
Duration of Most Frequently Observed Adverse Events (AEs)
The most frequently observed treatment-emergent AEs were gastrointestinal disorders which included diarrhea, nausea and vomiting. Duration of AE per event is calculated as AE stop date minus AE start date plus 1.
Baseline up to 30 days after last dose
Number of Participants With Best Overall Response (BOR) in Part 1
BOR:investigator assessment by modified Response Evaluation Criteria in Solid Tumors (RECIST), recorded from treatment start until disease progression/recurrence. Complete Response:disappearance of all lesions. Partial Response (PR):>=30% decrease in sum of longest diameters (SLDs) of target lesions (TLs) taking as reference baseline SLD. Progressive disease (PD):>=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of >=1 new lesion. Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.
Secondary Outcomes
Measure
Description
Time Frame
Maximum Tolerated Dose (MTD) for Prolonged Use
MTD for prolonged use was the highest dose level at which not more than 1 of 6 participants experienced DLT after 21 days of treatment (Cycle 1) and was selected as recommended dose in Phase 2, due to substantial number of Grade 2 gastrointestinal toxicities observed in the MTD lead-in cohort (500 mg).
Part 1 Day 1 up to Day 28
Other Outcomes
Measure
Description
Time Frame
Gene Expression at Baseline
Gene expression profile was evaluated by measuring transcript levels of messenger RNA (mRNA) in peripheral blood samples. Expression profiling of mRNA: done to measure the expressed genome of mRNA transcripts or done in a gene-specific targeted manner.
Baseline
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Advanced or recurrent solid malignancy confirmed histologically or cytologically for which no effective therapy is available.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
Measurable disease as outlined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Other inclusion applies.
Exclusion Criteria:
Use of any systemic antitumor agents or any investigational agent within 28 days before the first dose of test article is administered.
Prior exposure to SKI-606 or any other Src-kinase inhibitor, major surgery or radiotherapy within 14 days before the first dose of test article (recovery from previous surgery should be complete before day 1).
Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth (Treated CNS metastases must be stable for >= 2 weeks before day 1).
Hsyu PH, Mould DR, Abbas R, Amantea M. Population pharmacokinetic and pharmacodynamic analysis of bosutinib. Drug Metab Pharmacokinet. 2014;29(6):441-8. doi: 10.2133/dmpk.DMPK-13-RG-126. Epub 2014 Jun 10.
Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
FG001
Bosutinib 100 mg
Periods
Title
Milestones
Reasons Not Completed
Part 1: Dose Escalation
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
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Dose escalation
bosutinib
Drug
400mg QD bosutinib, as long as tolerated and disease under study does not worsen.
Colorectal Cancer
bosutinib
Drug
400mg QD bosutinib, as long as tolerated and disease under study does not worsen.
Pancreatic Cancer
bosutinib
Drug
400mg QD bosutinib, as long as tolerated and disease under study does not worsen.
Non-Small Cell Lung Cancer (NSCLC)
Part 1 Baseline, last week (Day 15 to 23) of cycles 2, 4, 6, 8 and thereafter every 3 cycles up to 30 days after last dose
Number of Participants With Best Overall Response (BOR) in Part 2
BOR: investigator assessment by modified RECIST, recorded from treatment start until disease progression/recurrence. Complete Response: disappearance of all lesions. PR: >=30% decrease in SLDs of TLs taking as reference baseline SLD. PD: >=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of >=1 new lesion. Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.
Part 2 Baseline, last week (Day 15 to 23) of cycles 2, 4, 6, 8 and thereafter every 3 cycles up to 30 days after last dose
Maximum Tolerated Dose (MTD) in Part 1
MTD: highest dose level at which not more than 1 of 6 participants experienced DLT after 21 days of treatment (Cycle 1). DLT included any grade 3 or 4 clinically-evident non-hematologic toxicity, grade 4 neutropenia of >= 7-day duration or with fever >= 38.5 degrees Celsius (febrile neutropenia); grade 4 thrombocytopenia >= 2-day duration or with bleeding requiring platelet transfusion, any clinically-significant grade >= 2 toxicity that requires >=14 days to resolve (to =< grade 1) which occurred in first 21 days of study and considered at least possibly related to bosutinib.
Part 1 Day 1 up to Day 28
Number of Participants With Change From Baseline in Laboratory Test Results
Criteria for potentially clinically significant (PCS) laboratory values: albumin <20, hemoglobin <80 gram/liter(g/L); alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase >5*upper limit of normal(ULN) milliunit/milliliter(mU/mL); bilirubin total, creatinine>3*ULN micromole/L; calcium <1.75 and >3.1,potassium <3 and >6, sodium <130, glucose <2.2,phosphorous <0.6 millimole/L; international normalized ratio >2*ULN, partial thromboplastin time, prothrombin time >2*ULN seconds; platelet count <50*10^9/L. Participants meeting at least 1 PCS criteria are reported.
Baseline up to end of treatment (Week 95)
Number of Participants With Change From Baseline in Electrocardiogram (ECG) and Chest X-ray
Number of participants with PCS ECG findings is reported on-therapy (OT) and at final visit (FV). Criteria for PCS ECG findings: heart rate (HR) =<45 beats/minute (bpm) and decrease (Dec) >15/>=120 bpm and decrease of >15 bpm; PR interval (Int) >=220 millisecond (msec), increase (Inc) >=20 msec, QRS Int >=120 msec, corrected QT (QTc) and QTc using fridericia formula(QTcF) Int >500 msec, increase >60 msec; no sinus rhythm; overall ECG abnormal. Participants with at least 1 measurement exceeding the criteria for PCS are reported.
Baseline up to end of treatment (Week 95)
Concomitant Medications Used for Management of Adverse Events (AEs)
Number of participants taking any non-study medications which were administered from Day 1 up to end of treatment (Week 95) as a management of an AE was to be reported.
Day 1 up to end of treatment (Week 95)
Change From Baseline in Karnofsky Performance Score
Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (complete healthy status). Higher score means higher ability to perform daily tasks.
Baseline up to end of treatment (Week 95)
Number of Participants With Change From Baseline in Physical Examination
Physical examinations included body weight, height and vital signs and only finding that exceeded the criterion for PCS was weight. Criteria for weight was: an increase or decrease of >=10% from baseline.
Baseline up to end of treatment (Week 95)
Number of Participants With Change From Baseline in Opthalmologic Examination
Ophthalmologic evaluation included visual acuity, funduscopic examination, and any clinically-significant abnormality.
Baseline up to end of treatment (Week 95)
Overall Survival (OS) in Part 2
Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from death case report forms (CRFs) or from follow-up contact data (where the participant current status was death).
Part 2 Baseline until death or 3, 6, 9 and 12 months after treatment discontinuation
Progression Free Survival (PFS) in Part 2
Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD, or from death CRFs).
Part 2 Baseline until death or 3, 6, 9 and 12 months after treatment discontinuation
Maximum Observed Plasma Concentration (Cmax)
0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14
Time to Reach Maximum Observed Plasma Concentration (Tmax)
0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14
Area Under the Concentration-Time Curve (AUC)
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Steady state concentration was achieved at Day 15.
0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14
Scottsdale
Arizona
85258
United States
Pfizer Investigational Site
Los Angeles
California
90033
United States
Pfizer Investigational Site
Tampa
Florida
33612
United States
Pfizer Investigational Site
Atlanta
Georgia
30341
United States
Pfizer Investigational Site
Indianpolis
Indiana
46202
United States
Pfizer Investigational Site
Baltimore
Maryland
21287
United States
Pfizer Investigational Site
Detroit
Michigan
48202
United States
Pfizer Investigational Site
Lansing
Michigan
48910
United States
Pfizer Investigational Site
New York
New York
10016
United States
Pfizer Investigational Site
New York
New York
10032
United States
Pfizer Investigational Site
Charlotte
North Carolina
28203
United States
Pfizer Investigational Site
Charlotte
North Carolina
28211
United States
Pfizer Investigational Site
UNC Chapel Hill
North Carolina
27514
United States
Pfizer Investigational Site
UNC Chapel Hill
North Carolina
27759
United States
Pfizer Investigational Site
Cleveland
Ohio
44106-1736
United States
Pfizer Investigational Site
San Antonio
Texas
78258
United States
Pfizer Investigational Site
Tyler
Texas
75702
United States
Pfizer Investigational Site
Seattle
Washington
98104
United States
Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
FG002
Bosutinib 200 mg
Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
FG003
Bosutinib 300 mg
Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
FG004
Bosutinib 400 mg
Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
FG005
Bosutinib 500 mg
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
FG006
Bosutinib 600 mg
Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
FG007
Maximum Tolerated Dose (MTD) lead-in
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
FG008
Colorectal Cancer
Participants with colorectal cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
FG009
Pancreatic Cancer
Participants with pancreatic cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
FG010
Non-small Cell Lung Cancer (NSCLC)
Participants with NSCLC received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
FG0004 subjects
FG0014 subjects
FG0026 subjects
FG0037 subjects
FG0047 subjects
FG0057 subjects
FG00610 subjects
FG0076 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
NOT COMPLETED
FG0004 subjects
FG0014 subjects
FG0026 subjects
FG0037 subjects
FG0047 subjects
FG0057 subjects
FG00610 subjects
FG0076 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0063 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Disease Progression
FG0003 subjects
FG0012 subjects
FG0025 subjects
FG0036 subjects
FG004
Symptomatic Deterioration
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Part 2: Recommended Phase 2 Dose (RP2D)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00837 subjects
FG00938 subjects
FG01025 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1
Participants received bosutinib capsule orally once daily continuously in 21-day cycles in dose escalation schemes of 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, MTD-lead in (500 mg) until disease progression, unacceptable toxicity, or consent withdrawal.
BG001
RP2D 400 mg
Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00051
BG001100
BG002151
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
BG00057.00± 12.67
BG00160.30± 11.48
BG00259.10± 11.95
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00029± participants
BG00154
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
Number of Participants With Dose-limiting Toxicities (DLT) in Part 1
DLT included any grade 3 or 4 clinically-evident non-hematologic toxicity, grade 4 neutropenia of greater than or equal to (>=) 7-day duration or with fever >= 38.5 degrees Celsius (febrile neutropenia); grade 4 thrombocytopenia >= 2-day duration or with bleeding requiring platelet transfusion, any clinically-significant grade >= 2 toxicity that requires >=14 days to resolve (to less than or equal to [=<] grade 1) which occurred in first 21 days of study and considered at least possibly related to bosutinib.
Safety population included all participants enrolled in a dose escalation cohort who had taken at least 1 dose of study medication.
Posted
Number
participants
Part 1 Baseline up to Day 28
ID
Title
Description
OG000
Bosutinib 50 mg
Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG001
Bosutinib 100 mg
Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG002
Bosutinib 200 mg
Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG003
Bosutinib 300 mg
Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG004
Bosutinib 400 mg
Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG005
Bosutinib 500 mg
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG006
Bosutinib 600 mg
Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG007
MTD-lead in
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Units
Counts
Participants
OG0004
OG0014
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG003
Primary
Number of Participants With Adverse Events (AEs) by Seriousness
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.
Safety population included all participants who had taken at least 1 dose of study medication.
Posted
Number
participants
Baseline up to 30 days after last dose
ID
Title
Description
OG000
Bosutinib 50 mg
Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG001
Bosutinib 100 mg
Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG002
Bosutinib 200 mg
Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG003
Bosutinib 300 mg
Primary
Duration of Most Frequently Observed Adverse Events (AEs)
The most frequently observed treatment-emergent AEs were gastrointestinal disorders which included diarrhea, nausea and vomiting. Duration of AE per event is calculated as AE stop date minus AE start date plus 1.
Safety population included all participants who had taken at least 1 dose of study medication.
Posted
Median
Full Range
days
Baseline up to 30 days after last dose
ID
Title
Description
OG000
Bosutinib 50 mg
Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG001
Bosutinib 100 mg
Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG002
Bosutinib 200 mg
Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG003
Bosutinib 300 mg
Primary
Number of Participants With Best Overall Response (BOR) in Part 1
BOR:investigator assessment by modified Response Evaluation Criteria in Solid Tumors (RECIST), recorded from treatment start until disease progression/recurrence. Complete Response:disappearance of all lesions. Partial Response (PR):>=30% decrease in sum of longest diameters (SLDs) of target lesions (TLs) taking as reference baseline SLD. Progressive disease (PD):>=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of >=1 new lesion. Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.
Efficacy evaluable population: participants who received at least 1 cycle (15 doses) of study medication, had no eligibility violations, did not use prohibited anti-cancer treatment, had baseline disease assessment, at least 1 disease assessment post-baseline/had experienced clinical progression/death before first post-baseline disease assessment.
Posted
Number
participants
Part 1 Baseline, last week (Day 15 to 23) of cycles 2, 4, 6, 8 and thereafter every 3 cycles up to 30 days after last dose
ID
Title
Description
OG000
Bosutinib 50 mg
Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG001
Bosutinib 100 mg
Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Primary
Number of Participants With Best Overall Response (BOR) in Part 2
BOR: investigator assessment by modified RECIST, recorded from treatment start until disease progression/recurrence. Complete Response: disappearance of all lesions. PR: >=30% decrease in SLDs of TLs taking as reference baseline SLD. PD: >=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of >=1 new lesion. Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.
Efficacy evaluable population: participants who received at least 1 cycle (15 doses) of study medication, had no eligibility violations, did not use prohibited anti-cancer treatment, had baseline disease assessment, at least 1 disease assessment post-baseline/had experienced clinical progression/death before first post-baseline disease assessment.
Posted
Number
participants
Part 2 Baseline, last week (Day 15 to 23) of cycles 2, 4, 6, 8 and thereafter every 3 cycles up to 30 days after last dose
ID
Title
Description
OG000
Colorectal Cancer
Participants with colorectal cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG001
Pancreatic Cancer
Participants with pancreatic cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Primary
Maximum Tolerated Dose (MTD) in Part 1
MTD: highest dose level at which not more than 1 of 6 participants experienced DLT after 21 days of treatment (Cycle 1). DLT included any grade 3 or 4 clinically-evident non-hematologic toxicity, grade 4 neutropenia of >= 7-day duration or with fever >= 38.5 degrees Celsius (febrile neutropenia); grade 4 thrombocytopenia >= 2-day duration or with bleeding requiring platelet transfusion, any clinically-significant grade >= 2 toxicity that requires >=14 days to resolve (to =< grade 1) which occurred in first 21 days of study and considered at least possibly related to bosutinib.
Safety population included all participants enrolled in a dose escalation cohort who had taken at least 1 dose of study medication.
Posted
Number
mg
Part 1 Day 1 up to Day 28
ID
Title
Description
OG000
All Participant
All participants who received bosutinib capsule (50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, MTD-lead in) orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Units
Counts
Participants
OG000
Secondary
Maximum Tolerated Dose (MTD) for Prolonged Use
MTD for prolonged use was the highest dose level at which not more than 1 of 6 participants experienced DLT after 21 days of treatment (Cycle 1) and was selected as recommended dose in Phase 2, due to substantial number of Grade 2 gastrointestinal toxicities observed in the MTD lead-in cohort (500 mg).
Safety population included all participants enrolled in a dose escalation cohort who had taken at least 1 dose of study medication.
Posted
Number
mg
Part 1 Day 1 up to Day 28
ID
Title
Description
OG000
All Participant
All participants who received bosutinib capsule (50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, MTD-lead in) orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Units
Counts
Participants
OG000
Secondary
Number of Participants With Change From Baseline in Laboratory Test Results
Criteria for potentially clinically significant (PCS) laboratory values: albumin <20, hemoglobin <80 gram/liter(g/L); alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase >5*upper limit of normal(ULN) milliunit/milliliter(mU/mL); bilirubin total, creatinine>3*ULN micromole/L; calcium <1.75 and >3.1,potassium <3 and >6, sodium <130, glucose <2.2,phosphorous <0.6 millimole/L; international normalized ratio >2*ULN, partial thromboplastin time, prothrombin time >2*ULN seconds; platelet count <50*10^9/L. Participants meeting at least 1 PCS criteria are reported.
Safety population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable (at least 1 on-therapy laboratory assessment) for this measure for each group respectively.
Posted
Number
participants
Baseline up to end of treatment (Week 95)
ID
Title
Description
OG000
Bosutinib 50 mg
Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG001
Bosutinib 100 mg
Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Secondary
Number of Participants With Change From Baseline in Electrocardiogram (ECG) and Chest X-ray
Number of participants with PCS ECG findings is reported on-therapy (OT) and at final visit (FV). Criteria for PCS ECG findings: heart rate (HR) =<45 beats/minute (bpm) and decrease (Dec) >15/>=120 bpm and decrease of >15 bpm; PR interval (Int) >=220 millisecond (msec), increase (Inc) >=20 msec, QRS Int >=120 msec, corrected QT (QTc) and QTc using fridericia formula(QTcF) Int >500 msec, increase >60 msec; no sinus rhythm; overall ECG abnormal. Participants with at least 1 measurement exceeding the criteria for PCS are reported.
Safety population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable (at least 1 on-therapy assessment) for this measure and 'n' represents participants evaluable under each category for each group respectively.
Posted
Number
participants
Baseline up to end of treatment (Week 95)
ID
Title
Description
OG000
Bosutinib 50 mg
Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG001
Bosutinib 100 mg
Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Secondary
Concomitant Medications Used for Management of Adverse Events (AEs)
Number of participants taking any non-study medications which were administered from Day 1 up to end of treatment (Week 95) as a management of an AE was to be reported.
Data for this pre-specified outcome measure was not statistically summarized for analysis, but collected and reported in individual participant listings as planned.
Posted
Day 1 up to end of treatment (Week 95)
ID
Title
Description
OG000
Bosutinib 50 mg
Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG001
Bosutinib 100 mg
Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG002
Bosutinib 200 mg
Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG003
Bosutinib 300 mg
Secondary
Change From Baseline in Karnofsky Performance Score
Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (complete healthy status). Higher score means higher ability to perform daily tasks.
Data for this pre-specified outcome was collected but not statistically summarized for analysis as there were no clinically significant changes observed.
Posted
Baseline up to end of treatment (Week 95)
ID
Title
Description
OG000
Bosutinib 50 mg
Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG001
Bosutinib 100 mg
Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG002
Bosutinib 200 mg
Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Secondary
Number of Participants With Change From Baseline in Physical Examination
Physical examinations included body weight, height and vital signs and only finding that exceeded the criterion for PCS was weight. Criteria for weight was: an increase or decrease of >=10% from baseline.
Safety population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable (at least 1 on-therapy assessment) for this measure for each group respectively.
Posted
Number
participants
Baseline up to end of treatment (Week 95)
ID
Title
Description
OG000
Bosutinib 50 mg
Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG001
Bosutinib 100 mg
Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG002
Bosutinib 200 mg
Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Secondary
Number of Participants With Change From Baseline in Opthalmologic Examination
Ophthalmologic evaluation included visual acuity, funduscopic examination, and any clinically-significant abnormality.
Safety population included all participants who had taken at least 1 dose of study medication.
Posted
Number
participants
Baseline up to end of treatment (Week 95)
ID
Title
Description
OG000
Bosutinib 50 mg
Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG001
Bosutinib 100 mg
Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG002
Bosutinib 200 mg
Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG003
Bosutinib 300 mg
Secondary
Overall Survival (OS) in Part 2
Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from death case report forms (CRFs) or from follow-up contact data (where the participant current status was death).
Efficacy evaluable population: participants who received at least 1 cycle (15 doses) of study medication, had no eligibility violations, did not use prohibited anti-cancer treatment, had baseline disease assessment, at least 1 disease assessment post-baseline/had experienced clinical progression/death before first post-baseline disease assessment.
Posted
Median
95% Confidence Interval
weeks
Part 2 Baseline until death or 3, 6, 9 and 12 months after treatment discontinuation
ID
Title
Description
OG000
Colorectal Cancer
Participants with colorectal cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG001
Pancreatic Cancer
Participants with pancreatic cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG002
Secondary
Progression Free Survival (PFS) in Part 2
Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for PD, or from death CRFs).
Efficacy evaluable population: participants who received at least 1 cycle (15 doses) of study medication, had no eligibility violations, did not use prohibited anti-cancer treatment, had baseline disease assessment, at least 1 disease assessment post-baseline/had experienced clinical progression/death before first post-baseline disease assessment.
Posted
Median
95% Confidence Interval
weeks
Part 2 Baseline until death or 3, 6, 9 and 12 months after treatment discontinuation
ID
Title
Description
OG000
Colorectal Cancer
Participants with colorectal cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG001
Pancreatic Cancer
Participants with pancreatic cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG002
Secondary
Maximum Observed Plasma Concentration (Cmax)
Analysis population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants evaluable for specific time points.
Posted
Mean
Standard Deviation
nanogram/milliliter (ng/mL)
0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14
ID
Title
Description
OG000
Bosutinib 50 mg
Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG001
Bosutinib 100 mg
Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG002
Bosutinib 200 mg
Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG003
Bosutinib 300 mg
Secondary
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Analysis population included all participants who had taken at least one dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants evaluable for specific time points.
Posted
Median
Full Range
hours
0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14
ID
Title
Description
OG000
Bosutinib 50 mg
Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG001
Bosutinib 100 mg
Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG002
Bosutinib 200 mg
Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG003
Bosutinib 300 mg
Secondary
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Analysis population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants evaluable for specific time points.
Posted
Mean
Standard Deviation
hours
0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14
ID
Title
Description
OG000
Bosutinib 50 mg
Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG001
Bosutinib 100 mg
Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG002
Bosutinib 200 mg
Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Secondary
Area Under the Concentration-Time Curve (AUC)
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Steady state concentration was achieved at Day 15.
Analysis population included all participants who had taken at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants evaluable for specific time points.
Posted
Mean
Standard Deviation
ng*hour/mL
0 hour (pre-dose) on Day 1, 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 (0 hour [pre-dose] on Day 15) hours post-dose on Day 14
ID
Title
Description
OG000
Bosutinib 50 mg
Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG001
Bosutinib 100 mg
Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG002
Bosutinib 200 mg
Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Other Pre-specified
Gene Expression at Baseline
Gene expression profile was evaluated by measuring transcript levels of messenger RNA (mRNA) in peripheral blood samples. Expression profiling of mRNA: done to measure the expressed genome of mRNA transcripts or done in a gene-specific targeted manner.
Data was not analyzed as the analysis was cancelled due to lack of samples provided from sites.
Posted
Baseline
ID
Title
Description
OG000
Bosutinib 50 mg
Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG001
Bosutinib 100 mg
Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG002
Bosutinib 200 mg
Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG003
Bosutinib 300 mg
Time Frame
Not provided
Description
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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
Bosutinib 50 mg
Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
4
4
4
4
EG001
Bosutinib 100 mg
Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
3
4
4
4
EG002
Bosutinib 200 mg
Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
2
6
6
6
EG003
Bosutinib 300 mg
Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
3
7
7
7
EG004
Bosutinib 400 mg
Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
5
7
7
7
EG005
Bosutinib 500 mg
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
2
7
7
7
EG006
Bosutinib 600 mg
Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
7
10
10
10
EG007
MTD lead-in
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
3
6
6
6
EG008
RP2D 400 mg
Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
47
100
99
100
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG0031 affected7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0080 affected100 at risk
Coagulopathy
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Intestinal ischaemia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Peptic ulcer haemorrhage
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Varices oesophageal
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Chest pain
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Chills
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Death
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Pneumonia staphylococcal
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Sepsis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Systemic candida
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Urinary tract infection staphylococcal
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Klebsiella bacteraemia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Parotitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Pneumonia klebsiella
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Feeding tube complication
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Liver function test abnormal
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
International normalised ratio increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hyperammonaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Neck mass
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Metastases to rectum
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Metastasis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Metastatic malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Colorectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Delirium
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hospitalisation
Surgical and medical procedures
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Circulatory collapse
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Thrombosis
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Colorectal cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG0033 affected7 at risk
EG0043 affected7 at risk
EG0051 affected7 at risk
EG0062 affected10 at risk
EG0071 affected6 at risk
EG00820 affected100 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hypercoagulation
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected4 at risk
EG0021 affected6 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Extrasystoles
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Palpitations
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Vision blurred
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Dry eye
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Eye oedema
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Diplopia
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Orbital oedema
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Visual impairment
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Photophobia
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected4 at risk
EG0012 affected4 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0003 affected4 at risk
EG0013 affected4 at risk
EG0023 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0024 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected4 at risk
EG0010 affected4 at risk
EG0022 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0012 affected4 at risk
EG0022 affected6 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0023 affected6 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected4 at risk
EG0010 affected4 at risk
EG0022 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0022 affected6 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0021 affected6 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Gastrointestinal oedema
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Fatigue
General disorders
MedDRA
Non-systematic Assessment
EG0003 affected4 at risk
EG0013 affected4 at risk
EG0024 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA
Non-systematic Assessment
EG0002 affected4 at risk
EG0011 affected4 at risk
EG0023 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG0002 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Asthenia
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Early satiety
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Catheter thrombosis
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Chest pain
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0021 affected6 at risk
EG003
Chills
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Chest discomfort
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Crepitations
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Gait disturbance
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Nodule
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Pain
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Catheter site related reaction
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Local swelling
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Oedema
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Temperature intolerance
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Feeling hot
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Localised oedema
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Laryngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Oral herpes
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Skin infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Septic shock
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Incision site pain
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Procedural site reaction
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Contrast media reaction
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Drug toxicity
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Weight decreased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0022 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0022 affected6 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0022 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Electrocardiogram T wave abnormal
Investigations
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Pulmonary function test decreased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
White blood cell count increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Blood albumin decreased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Body temperature increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
International normalised ratio increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Urine analysis abnormal
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
White blood cells urine positive
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Blood phosphorus increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Blood urea decreased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Cardiac murmur
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Platelet count decreased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Urine output decreased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0003 affected4 at risk
EG0011 affected4 at risk
EG0022 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0013 affected4 at risk
EG0020 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0002 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Metabolic alkalosis
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0022 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0002 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0002 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0002 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Neck mass
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Cervix neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Haemangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0003 affected4 at risk
EG0011 affected4 at risk
EG0022 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0022 affected6 at risk
EG003
Cervical cord compression
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Migraine
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Somnolence
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Amnesia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Ataxia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Convulsion
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Lethargy
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0002 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Depression
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Agitation
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Anger
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Bladder spasm
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Oedema genital
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Endometriosis
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Haemorrhagic ovarian cyst
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0021 affected6 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0011 affected4 at risk
EG0020 affected6 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0021 affected6 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Periorbital oedema
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Rash follicular
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Pallor
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Flushing
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0011 affected4 at risk
EG0021 affected6 at risk
EG003
Hot flush
Vascular disorders
MedDRA
Non-systematic Assessment
EG0001 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0021 affected6 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected4 at risk
EG0010 affected4 at risk
EG0020 affected6 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
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D009369
Neoplasms
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C471992
bosutinib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
4 subjects
FG0056 subjects
FG0067 subjects
FG0074 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0084 subjects
FG0090 subjects
FG0102 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00833 subjects
FG00938 subjects
FG01023 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00821 subjects
FG00929 subjects
FG01015 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0085 subjects
FG0093 subjects
FG0102 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0092 subjects
FG0103 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0086 subjects
FG0094 subjects
FG0103 subjects
83
Male
BG00022
BG00146
BG00268
7
OG0047
OG0057
OG00610
OG0076
1
OG0040
OG0051
OG0063
OG0070
Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG004
Bosutinib 400 mg
Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG005
Bosutinib 500 mg
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG006
Bosutinib 600 mg
Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG007
MTD-lead in
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG008
RP2D 400 mg
Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Units
Counts
Participants
OG0004
OG0014
OG0026
OG0037
OG0047
OG0057
OG00610
OG0076
OG008100
Title
Denominators
Categories
AEs
Title
Measurements
OG0004
OG0014
OG0026
OG0037
OG0047
OG0057
OG00610
OG0076
OG008100
Serious adverse events (SAEs)
Title
Measurements
OG0004
OG0013
OG0022
OG003
Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG004
Bosutinib 400 mg
Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG005
Bosutinib 500 mg
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG006
Bosutinib 600 mg
Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG007
MTD lead-in
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG008
RP2D 400 mg
Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Units
Counts
Participants
OG0004
OG0014
OG0026
OG0037
OG0047
OG0057
OG00610
OG0076
OG008100
Title
Denominators
Categories
Diarrhea
Title
Measurements
OG0001.0(1 to 1)
OG001NA(NA to NA)Data was not analyzed as no participants reported the event in this particular cohort.
OG00212.0(1 to 27)
OG0032.0(1 to 15)
OG0043.5(1 to 7)
OG0057.0(1 to 33)
OG0061.0(1 to 23)
OG0071.0(1 to 30)
OG0083.0(1 to 75)
Nausea
Title
Measurements
OG0002.0(1 to 14)
OG0011.0(1 to 11)
OG0021.0(1 to 8)
OG003
Vomiting
Title
Measurements
OG0002.5(1 to 4)
OG0011.0(1 to 9)
OG002NA(NA to NA)Data was not analyzed as no participants reported the event in this particular cohort.
OG003
OG002
Bosutinib 200 mg
Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG003
Bosutinib 300 mg
Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG004
Bosutinib 400 mg
Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG005
Bosutinib 500 mg
Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG006
Bosutinib 600 mg
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG007
MTD-lead in
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0036
OG0046
OG0056
OG0064
OG0073
Title
Denominators
Categories
Complete response
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Partial response
Title
Measurements
OG0000
OG0010
OG0020
OG003
Stable disease
Title
Measurements
OG0000
OG0012
OG0022
OG003
Progressive disease
Title
Measurements
OG0003
OG0011
OG0024
OG003
Indeterminate
Title
Measurements
OG0000
OG0010
OG0020
OG003
Not done
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
Non-small Cell Lung Cancer (NSCLC)
Participants with NSCLC received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Units
Counts
Participants
OG00034
OG00122
OG00219
Title
Denominators
Categories
Complete response
Title
Measurements
OG0000
OG0010
OG0020
Partial response
Title
Measurements
OG0000
OG0010
OG0020
Stable disease
Title
Measurements
OG00010
OG0013
OG0029
Progressive disease
Title
Measurements
OG00024
OG00118
OG0029
Indeterminate
Title
Measurements
OG0000
OG0010
OG0020
Not done
Title
Measurements
OG0000
OG0011
OG0021
51
Title
Denominators
Categories
Title
Measurements
OG000500
51
Title
Denominators
Categories
Title
Measurements
OG000400
OG002
Bosutinib 200 mg
Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG003
Bosutinib 300 mg
Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG004
Bosutinib 400 mg
Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG005
Bosutinib 500 mg
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG006
Bosutinib 600 mg
Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG007
MTD-lead in
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG008
RP2D 400 mg
Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Units
Counts
Participants
OG0004
OG0014
OG0026
OG0037
OG0047
OG0057
OG0068
OG0076
OG00896
Title
Denominators
Categories
Albumin (<20 g/L)
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0081
Alkaline phosphatase (>5*ULN)
Title
Measurements
OG0000
OG0011
OG0020
OG003
Bilirubin total (>3*ULN)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Calcium (<1.75 mmol/L)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Calcium (>3.1 mmol/L)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Creatinine (>3*ULN)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Glucose (<2.2 mmol/L)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Phosphorus (<0.6 mmol/L)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Potassium (<3 mmol/L)
Title
Measurements
OG0000
OG0011
OG0020
OG003
Potassium (>6 mmol/L)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Aspartate aminotransferase (> 5*ULN))
Title
Measurements
OG0000
OG0010
OG0020
OG003
Alanine aminotransferase (> 5*ULN)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium (<130 mmol/L)
Title
Measurements
OG0000
OG0010
OG0020
OG003
International normalized ratio (>2*ULN)
Title
Measurements
OG0000
OG0011
OG0020
OG003
Prothrombin time (>2*ULN)
Title
Measurements
OG0000
OG0011
OG0020
OG003
Partial thromboplastin time (>2*ULN)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hemoglobin (<80 g/L)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Platelets (<50*10^9/L)
Title
Measurements
OG0000
OG0011
OG0020
OG003
OG002
Bosutinib 200 mg
Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG003
Bosutinib 300 mg
Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG004
Bosutinib 400 mg
Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG005
Bosutinib 500 mg
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG006
Bosutinib 600 mg
Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG007
MTD-lead in
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG008
RP2D 400 mg
Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG000NAData for this pre-specified category was collected but not statistically summarized for analysis as there were no clinically significant changes observed.
OG001NAData for this pre-specified category was collected but not statistically summarized for analysis as there were no clinically significant changes observed.
OG002NAData for this pre-specified category was collected but not statistically summarized for analysis as there were no clinically significant changes observed.
Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG004
Bosutinib 400 mg
Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG005
Bosutinib 500 mg
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG006
Bosutinib 600 mg
Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG007
MTD-lead in
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG008
RP2D 400 mg
Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG003
Bosutinib 300 mg
Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG004
Bosutinib 400 mg
Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG005
Bosutinib 500 mg
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG006
Bosutinib 600 mg
Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG007
MTD-lead in
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG008
RP2D 400 mg
Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG003
Bosutinib 300 mg
Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG004
Bosutinib 400 mg
Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG005
Bosutinib 500 mg
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG006
Bosutinib 600 mg
Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG007
MTD-lead in
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG008
RP2D 400 mg
Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Units
Counts
Participants
OG0004
OG0014
OG0026
OG0037
OG0047
OG0057
OG0067
OG0076
OG00887
Title
Denominators
Categories
Weight (decrease >=10%)
Title
Measurements
OG0000
OG0010
OG0022
OG0032
OG0040
OG0050
OG0060
OG0070
OG0083
Weight (increase >=10%)
Title
Measurements
OG0001
OG0011
OG0020
OG003
Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG004
Bosutinib 400 mg
Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG005
Bosutinib 500 mg
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG006
Bosutinib 600 mg
Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG007
MTD-lead in
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG008
RP2D 400 mg
Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Units
Counts
Participants
OG0004
OG0014
OG0026
OG0037
OG0047
OG0057
OG00610
OG0076
OG008100
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
OG0070
OG0084
Non-small Cell Lung Cancer (NSCLC)
Participants with NSCLC received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Units
Counts
Participants
OG00034
OG00122
OG00219
Title
Denominators
Categories
Title
Measurements
OG00027.7(23.0 to 34.3)
OG00114.7(8.1 to 22.9)
OG00234.0(16.7 to 55.0)
Non-small Cell Lung Cancer (NSCLC)
Participants with NSCLC received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Units
Counts
Participants
OG00034
OG00122
OG00219
Title
Denominators
Categories
Title
Measurements
OG0006.0(5.3 to 7.1)
OG0016.0(5.3 to 6.1)
OG0025.7(5.3 to 19.3)
Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG004
Bosutinib 400 mg (Part 1 + Part 2)
Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal in both Part 1 and Part 2 participants.
OG005
Bosutinib 500 mg
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG006
Bosutinib 600 mg
Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Units
Counts
Participants
OG0004
OG0014
OG0026
OG0037
OG00469
OG00513
OG00610
Title
Denominators
Categories
Day 1 (n = 4, 4, 6, 7, 54, 13, 10)
Title
Measurements
OG0004.89± 3.69
OG00117.0± 9.75
OG00243.1± 26.9
OG00363.7± 34.7
OG004117.0± 69.0
OG005125.0± 63.2
OG006206.0± 190.0
Day 15 (n = 3, 4, 5, 5, 69, 10, 2)
Title
Measurements
OG0006.92± 3.07
OG00119.6± 3.31
OG00295.4± 60.0
OG003
Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG004
Bosutinib 400 mg (Part 1 + Part 2)
Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal in both Part 1 and Part 2 participants.
OG005
Bosutinib 500 mg
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG006
Bosutinib 600 mg
Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Units
Counts
Participants
OG0004
OG0014
OG0026
OG0037
OG00469
OG00513
OG00610
Title
Denominators
Categories
Day 1 (n = 4, 4, 6, 7, 54, 13, 10)
Title
Measurements
OG0006.01(4.00 to 8.00)
OG0014.08(2.00 to 6.00)
OG0026.00(2.05 to 8.00)
OG0036.00(3.23 to 6.17)
OG0044.00(1.00 to 8.68)
OG0054.00(2.00 to 8.00)
OG0066.00(1.30 to 8.00)
Day 15 (n = 3, 4, 5, 5, 69, 10, 2)
Title
Measurements
OG0004.00(3.00 to 6.00)
OG0013.50(2.25 to 4.03)
OG0024.00(3.00 to 6.10)
OG003
OG003
Bosutinib 300 mg
Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG004
Bosutinib 400 mg (Part 1 + Part 2)
Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal in both Part 1 and Part 2 participants.
OG005
Bosutinib 500 mg
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG006
Bosutinib 600 mg
Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Units
Counts
Participants
OG0004
OG0014
OG0026
OG0037
OG00469
OG00513
OG00610
Title
Denominators
Categories
Day 1 (n = 3, 4, 6, 7, 47, 13, 10)
Title
Measurements
OG00012.86± 7.36
OG00118.61± 4.91
OG00220.80± 6.07
OG00317.12± 6.01
OG00418.63± 7.67
OG00521.87± 7.39
OG00619.94± 5.47
Day 15 (n = 3, 4, 5, 4, 53, 9, 2)
Title
Measurements
OG00025.84± 12.26
OG00164.65± 67.31
OG00230.04± 20.13
OG003
OG003
Bosutinib 300 mg
Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG004
Bosutinib 400 mg (Part 1 + Part 2)
Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal in both Part 1 and Part 2 participants.
OG005
Bosutinib 500 mg
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG006
Bosutinib 600 mg
Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Units
Counts
Participants
OG0004
OG0014
OG0026
OG0037
OG00469
OG00513
OG00610
Title
Denominators
Categories
Day 1 (n = 3, 4, 6, 7, 47, 13, 10)
Title
Measurements
OG000129.0± 131.0
OG001284.0± 72.8
OG002920.0± 338.0
OG0031200.0± 736.0
OG0042340.0± 1230.0
OG0052950.0± 1470.0
OG0064300.0± 3310.0
Day 15 (n = 3, 4, 5, 4, 58, 9, 2)
Title
Measurements
OG000114.0± 33.3
OG001329.0± 58.1
OG0021670.0± 1130.0
OG003
Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG004
Bosutinib 400 mg
Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG005
Bosutinib 500 mg
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG006
Bosutinib 600 mg
Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
OG007
MTD-lead in
Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
0 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0080 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0081 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0080 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0082 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0081 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0081 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0081 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
EG0080 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0080 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0061 affected10 at risk
EG0071 affected6 at risk
EG0081 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0051 affected7 at risk
EG0062 affected10 at risk
EG0070 affected6 at risk
EG0081 affected100 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected7 at risk
EG0061 affected10 at risk
EG0071 affected6 at risk
EG0080 affected100 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected7 at risk
EG0061 affected10 at risk
EG0071 affected6 at risk
EG0082 affected100 at risk
1 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0080 affected100 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0080 affected100 at risk
1 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
EG0081 affected100 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0081 affected100 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0080 affected100 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0080 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
EG0080 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
EG0081 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
EG0080 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0083 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0082 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0081 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0081 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0081 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0081 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0082 affected100 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0080 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0081 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0081 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0083 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0083 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0081 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0081 affected100 at risk
0 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0084 affected100 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected7 at risk
EG0061 affected10 at risk
EG0070 affected6 at risk
EG0081 affected100 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0080 affected100 at risk
1 affected
7 at risk
EG0040 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0082 affected100 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0080 affected100 at risk
0 affected
7 at risk
EG0041 affected7 at risk
EG0050 affected7 at risk
EG0060 affected10 at risk
EG0070 affected6 at risk
EG0080 affected100 at risk
0 affected
7 at risk
EG0041 affected7 at risk
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9.0
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OG0060
OG0070
OG0083
0
OG0040
OG0051
OG0060
OG0070
OG0083
0
OG0040
OG0050
OG0060
OG0070
OG0083
0
OG0040
OG0050
OG0060
OG0070
OG0081
0
OG0040
OG0050
OG0060
OG0070
OG00829
7
OG0046
OG0056
OG0068
OG0076
OG00863
0
OG0040
OG0050
OG0060
OG0070
OG0081
0
OG0040
OG0050
OG0060
OG0070
OG0080
0
OG0040
OG0050
OG0061
OG0070
OG0084
0
OG0040
OG0050
OG0060
OG0070
OG0081
0
OG0040
OG0050
OG0060
OG0070
OG0082
0
OG0042
OG0053
OG0063
OG0071
OG00818
OG003NAData for this pre-specified category was collected but not statistically summarized for analysis as there were no clinically significant changes observed.
OG004NAData for this pre-specified category was collected but not statistically summarized for analysis as there were no clinically significant changes observed.
OG005NAData for this pre-specified category was collected but not statistically summarized for analysis as there were no clinically significant changes observed.
OG006NAData for this pre-specified category was collected but not statistically summarized for analysis as there were no clinically significant changes observed.
OG007NAData for this pre-specified category was collected but not statistically summarized for analysis as there were no clinically significant changes observed.
OG008NAData for this pre-specified category was collected but not statistically summarized for analysis as there were no clinically significant changes observed.
1
OG0040
OG0051
OG0061
OG0070
OG0083
76.6
± 37.0
OG004190.0± 116.0
OG005273.0± 197.0
OG006304.0± NAStandard deviation obtained by sampling distribution of 2 participants was not meaningful, hence not reported.
4.02
(3.00 to 6.00)
OG0044.00(1.00 to 8.33)
OG0055.00(1.00 to 8.00)
OG0063.53(3.00 to 4.05)
19.35
± 7.54
OG00419.89± 16.72
OG00523.25± 15.00
OG00616.29± NAStandard deviation obtained by sampling distribution of 2 participants was not meaningful, hence not reported.
1170.0
± 699.0
OG0042900.0± 1700.0
OG0053580.0± 1820.0
OG0064220.0± NAStandard deviation obtained by sampling distribution of 2 participants was not meaningful, hence not reported.