Safety and Anti-leukemic Activity of Vodobatinib (K0706)... | NCT02629692 | Trialant
NCT02629692
Sponsor
Sun Pharma Advanced Research Company Limited
Status
Terminated
Last Update Posted
May 13, 2026Actual
Enrollment
124Actual
Phase
Phase 1Phase 2
Conditions
Healthy (For Part A)
Chronic Myeloid Leukemia (for Part B and C)
Interventions
Vodobatinib (K0706) capsules
Countries
United States
Belgium
France
Hungary
India
Italy
Romania
South Korea
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02629692
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CLR_15_03 V 12 Amendment 12
Secondary IDs
Not provided
Brief Title
Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment of Ph+ CML Resistant/Intolerant to ≥3 Prior CML Therapies
Official Title
A Two-Part Phase 1/2 Study to Determine Safety, Tolerability, Pharmacokinetics, and Activity of K0706, a Novel Tyrosine Kinase Inhibitor (TKI), in Healthy Subjects and in Subjects With Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
Acronym
Not provided
Organization
Sun Pharma Advanced Research Company LimitedINDUSTRY
Status Module
Record Verification Date
Apr 2026
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Closed for administrative, non-safety-related reasons.
Expanded Access Info
YesNCT07517315Temporarily not available
Start Date
Jun 27, 2016Actual
Primary Completion Date
Jan 3, 2025Actual
Completion Date
Jan 3, 2025Actual
First Submitted Date
Dec 10, 2015
First Submission Date that Met QC Criteria
Dec 10, 2015
First Posted Date
Dec 14, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 2, 2025
Results First Submitted that Met QC Criteria
Apr 21, 2026
Results First Posted Date
May 13, 2026Actual
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
Apr 21, 2026
Last Update Posted Date
May 13, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Sun Pharma Advanced Research Company LimitedINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
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
Phase 1/2 study to determine safety, tolerability, pharmacokinetics, and anti-leukemic activity of Vodobatinib (K0706) in treatment-refractory/intolerant CML
Detailed Description
Part A ( for Healthy volunteers) of the study is completed.
Part B dose-escalation study is completed. Recruitment in dose expansion is completed.
Part C study in subjects with treatment-resistant/intolerant CML is also completed.
Conditions Module
Conditions
Healthy (For Part A)
Chronic Myeloid Leukemia (for Part B and C)
Keywords
CML
Chronic Myelogenous Leukemia
K0706
Vodobatinib
ponatinib-refractory/intolerant
treatment refractory chronic myeloid leukemia
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
124Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Vodobatinib (K0706) capsules
Experimental
Drug: Vodobatinib (K0706) capsules
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Vodobatinib (K0706) capsules
Drug
Part A: Oral Vodobatinib (K0706) capsules in single ascending doses.
Part B: Oral Vodobatinib (K0706) capsules in multiple ascending doses, once daily.
Part C: Oral Vodobatinib (K0706) capsules at recommended phase 2 dose of 174 mg, once daily.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Examination of the Safety and Tolerability of Single Oral Doses of K0706
Number of Participants with Adverse Events in Part A
Approximately 56 ± 2 days
To Determine the Maximum Tolerated Dose (MTD) as Determined by Frequency of Dose Limiting Toxicities
PART B
Dose Limiting toxicities observed over a 4 week period
Incidence and Severity of Treatment Emergent AEs (PART B)
Number of Participants with treatment emergent Adverse Events in Part B
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
For CML Subjects in CP at Study Entry
PART C: Proportion of subjects achieving Major Cytogenetic Response [ defined as complete cytogenetic response (CCyR; 0% Ph+metaphases) or partial cytogenetic response (PCyR; 1-35% Ph+ metaphases)] as assessed by conventional Karyotyping of Bone marrow aspirate
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
For CML Subjects in AP at Study Entry
PART C: Proportion of subjects achieving Major Hematologic Response [ defined as complete hematologic response (CHR) or no evidence of leukemia (NEL)] as assessed by complete blood count of peripheral blood sample
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
For CML Subjects in BP at Study Entry
PART C: Proportion of subjects achieving Major Hematologic Response [defined as complete hematologic response (CHR) or no evidence of leukemia (NEL)] as assessed by complete blood count of peripheral blood sample
Secondary Outcomes
Measure
Description
Time Frame
To Characterize the Pharmacokinetics (Cmax) of K0706 After Single Oral Doses in Healthy Male Subjects
Part A
Approximately 28 ± 2 days
To Characterize the Pharmacokinetics of K0706 (Cmax) After Single Oral Doses in Fasted and Fed State in Healthy Male Subjects
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Part A Inclusion Criteria:
Healthy males aged 18 to 55 years
Part B Key Inclusion Criteria:
Subjects diagnosed with Ph+ CML-CP, Ph+ CML-AP, Ph+ CML-BP, or Ph+ ALL who are refractory or intolerant to at least 3 TKIs or are not eligible (e.g.: due to comorbidities, hypersensitivity to excipients, lack of insurance coverage) for their local country's regulatory approved and medically appropriate TKIs (e.g., a TKI that is effective against mutations in the patient's tumor).
Part C Key Inclusion Criteria:
Subjects diagnosed with Ph+ CML-CP, Ph+ CML-AP, Ph+ CML-BP, who are resistant and/or intolerant to ≥ 3 prior TKIs one of which includes ponatinib (Subjects with Ph+ ALL are not included).
Part B and C: Other Inclusion Criteria
Willing and able to give written, and dated, informed consent
Male or female aged ≥ 18 years
Willing and able to comply with the scheduled visits
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Part A Exclusion Criteria:
Any major surgery, as determined by the Investigator, within 4 weeks of IMP administration
Inability to undergo venipuncture and/or tolerate venous access
Positive exclusion tests: HIV, hepatitis B surface antigen, or hepatitis C virus
Known or suspected history of significant drug abuse as judged by the Investigator
Part B and C Exclusion Criteria:
Presence of T315I
Any major surgery, as determined by the Investigator, within 4 weeks of IMP administration
Inability to undergo venipuncture and/or tolerate venous access
Positive exclusion tests: urine pregnancy tests (if applicable), HIV, hepatitis B surface antigen, or hepatitis C virus
Known or suspected history of significant drug abuse as judged by the Investigator
Received any other investigational agent within 30 days or a washout of at least 5 half-lives, whichever is longer of IMP administration
Subjects who are eligible for potentially curative therapy that is available, including hematopoietic stem cell transplant
Another primary malignancy within the past 3 years or earlier (except for adequately treated non-melanoma skin cancer or cervical cancer in situ
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
The Oncology Institute of Hope and Innovation, Innovative Clinical Research Institute
Cortes JE, Kim DW, Saikia T, Khattry N, Rathnam K, Alvarado Y, Hannah G, Tantravahi SK, Apperley JF, Charbonnier A, Garcia-Gutierrez V, Lucchesi A, Dima D, Illes A, Popov VM, Abruzzese E, Nag A, Apte S, Badar T, Yao SL, Saxena U, Sreenivasan J, Inamdar S, Chimote G, Nicolini FE. Vodobatinib for patients with Philadelphia chromosome-positive chronic myeloid leukaemia resistant or intolerant to multiple lines of previous therapy: an open-label, multicentre, phase 1/2 trial. Lancet Haematol. 2025 Mar;12(3):e201-e213. doi: 10.1016/S2352-3026(24)00354-5. Epub 2025 Feb 7.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Part A comprised of 40 healthy subjects, Part B comprised of 61 patients and Part C comprised of 23 patients.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: Dose Level 1 (SAD Study)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 6mg
FG001
Part A: Dose Level 2 (SAD Study)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 12mg
Periods
Title
Milestones
Reasons Not Completed
Part A
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
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Sep 12, 2019
Dec 2, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Czechia
Singapore
Turkey (Türkiye)
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Part A: Single ascending dose in healthy volunteers.
Part B: Multiple ascending dose safety and tolerability study in subjects with CML or Ph + ALL.
Part C: Efficacy and safety study in subjects with treatment-resistant CML
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Part B and C: Single arm (Open-label)
Part A: 2 arms: Investigational agent arm and Placebo arm (Double-blind).
Who Masked
Not provided
Vodobatinib (K0706) capsules
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Part A
Approximately 28 ± 2 days
Pharmacokinetic Profile of K0706 - Cmax [The Maximum (Peak) Observed Drug Concentration After Dose Administration]
PART B
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
Pharmacokinetic Profile of Vodobatinib (K0706) - Tmax [The Time to Reach Maximum (Peak) Drug Concentration After Dose Administration]
PART B
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
Pharmacokinetic Profile of Vodobatinib (K0706) - AUC[0-tau] (AUC Over the Dosing Interval of 0-24 Hours).
PART B
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
In Subjects With CML- CP:Proportion of Subjects Achieving Complete Hematological Response as Assessed by Complete Blood Count of Peripheral Blood Sample
PART C
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
In Subjects With CML- CP:Proportion of Subjects Achieving Complete Cytogenetic Response as Assessed by Conventional Karyotyping of Bone Marrow Aspirate
PART C
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
In Subjects With CML- CP:Proportion of Subjects Achieving Major Molecular Response as Assessed by BCR-ABL Transcript Levels (BCR-ABL1 Ratio of ≤ 0.1%) in Peripheral Blood Using PCR (Polymerase Chain Reaction)
PART C
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
In Subjects With CML-AP & BP: Proportion of Subjects Achieving Complete Cytogenetic Response as Assessed by Conventional Karyotyping of Bone Marrow Aspirate
PART C
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
In Subjects With CML-AP & BP: Proportion of Subjects Achieving Partial Cytogenetic Response (PCyR) as Assessed by Conventional Karyotyping of Bone Marrow Aspirate
Part C
All subjects will be followed up for 60 months from the first dose of K0706
In Subjects With CML-AP & BP: Proportion of Subjects Achieving Major Molecular Response as Assessed by BCR-ABL Transcript Levels (BCR-ABL1 Ratio of ≤ 0.1%) in Peripheral Blood Using PCR (Polymerase Chain Reaction)
PART C
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Time to Major Cytogenetic Response (MCyR): Time to MCyR is the Time From First Dose to First MCyR (0-35% Ph+ Metaphases); Computed Only for CML-CP Subjects Who Achieved MCyR
PART C; Time to response was calculated as time from date of first dose to date of first occurrence of best response
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Time to Major Molecular Response : Time to MMR is the Time From First Dose to First MMR (BCR-ABL1 Ratio of ≤ 0.1%) Computed Only for CML-CP Subjects Who Achieved MMR
PART C; Time to response was calculated as time from date of first dose to date of first occurrence of best response
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
In All Subjects Progression Free Survival (PFS)
PART C
All subjects will be followed up at 12, 24, 36 months from the first dose of K0706 and beyond, until intolerance, disease progression or subject withdrawal from the study.
In All Subjects Overall Survival (OS)
PART C
All subjects will be followed up at 12, 24, 36 months from the first dose of K0706 and beyond, until intolerance, disease progression or subject withdrawal from the study.
Incidence and Severity of Treatment Emergent AEs (PART C)
Number of Participants with treatment emergent Adverse Events in Part C
All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Pharmacokinetic Profile of K0706 - Cmax [The Maximum (Peak) Observed Drug Concentration After Dose Administration]
PART C
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
Pharmacokinetic Profile of Vodobatinib (K0706) - Tmax [The Time to Reach Maximum (Peak) Drug Concentration After Dose Administration]
PART C
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
To Characterize the Pharmacokinetics (AUC(0-inf)) of K0706 After Single Oral Doses in Healthy Male Subjects
Part A
Approximately 28 ± 2 days
To Characterize the Pharmacokinetics of K0706 (AUC(0-inf)) After Single Oral Doses in Fasted and Fed State in Healthy Male Subjects
Part A
Approximately 28 ± 2 days
UCLA Hematologic Malignancy Program
Los Angeles
California
90024
United States
Mayo Clinic
Jacksonville
Florida
32224
United States
Board of Regents of the University System of Georgia
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
Meldola
Forli - Cesena
47014
Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
Monza
Milano
20900
Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan
20122
Italy
Ospedale Sant'Eugenio
Roma
00144
Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma
00161
Italy
Spitalul Clinic Colentina
Bucharest
020125
Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
Cluj-Napoca
400124
Romania
Spitalul Clinic Municipal Filantropia Craiova
Craiova
200143
Romania
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Gyeonggi-do
6591
South Korea
Uijeongbu Eulji Medical Center, Eulji University
Gyeonggi-do
11759
South Korea
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Badalona
Barcelona
08916
Spain
Hospital Universitari Vall d'Hebron
Barcelona
08035
Spain
Hospital Universitario Ramon y Cajal
Madrid
28034
Spain
Hospital Universitario 12 de Octubre
Madrid
28041
Spain
Hospital Universitario La Paz
Madrid
28046
Spain
King's College Hospital
London
Greater London
SE5 9NU
United Kingdom
Hammersmith Hospital
London
Greater London
W120HS
United Kingdom
FG002
Part A: Dose Level 3 (SAD Study)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 24mg
FG003
Part A: Placebo (SAD Study)
Part A: Oral placebo capsules
FG004
Part A: Dose Level 1 (FE Study)
Part A: Oral vodobatinib (K0706) capsules of 6mg
FG005
Part A: Dose Level 2 (FE Study)
Part A: Oral vodobatinib (K0706) capsules of 24mg
FG006
Part B: Dose Level 1 (ESC)
Part B: Oral vodobatinib (K0706) capsules in once daily 12mg
FG007
Part B: Dose Level 2 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 24mg
FG008
Part B: Dose Level 3 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 48mg
FG009
Part B: Dose Level 4 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 66mg
FG010
Part B: Dose Level 5 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 90mg
FG011
Part B: Dose Level 6 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 126mg
FG012
Part B: Dose Level 7 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 174mg
FG013
Part B: Dose Level 8 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 204mg
FG014
Part B: Dose Level 9 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 240mg
FG015
Part B: Dose Level 1 (EXP)
Part B: Oral vodobatinib (K0706) capsules once daily 174 mg
FG016
Part C: Dose Level 1
Part C: Oral vodobatinib (K0706) capsules at 90mg once daily. Includes a patient with CML-CP
FG017
Part C: Dose Level 2 (CML-AP)
Part C: Oral vodobatinib (K0706) capsules at 174mg, once daily. Includes patients with CML-AP
FG018
Part C: Dose Level 2 (CML-CP)
Part C: Oral vodobatinib (K0706) capsules at 174mg, once daily. Includes patients with CML-CP
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0048 subjects
FG0058 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
COMPLETED
FG0005 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0048 subjects
FG0058 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
Part B
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
FG0086 subjects
FG0097 subjects
FG0103 subjects
FG0117 subjects
FG01215 subjects
FG0136 subjects
FG0143 subjects
FG01512 subjects
FG0160 subjects
FG0170 subjects
FG0180 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
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part C
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0161 subjects
FG0175 subjects
FG01817 subjects
CML-CP
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
CML-AP
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: Dose Level 1 (SAD)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 6mg
BG001
Part A: Dose Level 2 (SAD)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 12mg
BG002
Part A: Dose Level 3 (SAD)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 24mg
BG003
Part A: Placebo (SAD)
Part A: Oral placebo capsules once daily
BG004
Part A: Dose Level 1 (FE Study)
Part A: Oral vodobatinib (K0706) capsules 6mg
BG005
Part A: Dose Level 2 (FE Study)
Part A: Oral vodobatinib (K0706) capsules 24mg
BG006
Part B: Dose Level 1 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 12mg
BG007
Part B: Dose Level 2 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 24mg
BG008
Part B: Dose Level 3 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 48mg
BG009
Part B: Dose Level 4 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 66mg
BG010
Part B: Dose Level 5 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 90mg
BG011
Part B: Dose Level 6 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 126mg
BG012
Part B: Dose Level 7 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 174mg
BG013
Part B: Dose Level 8 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 204mg
BG014
Part B: Dose Level 9 (ESC)
Part B: Oral vodobatinib (K0706) capsules once daily 240mg
BG015
Part B: Dose Level 1 (EXP)
Part B: Oral vodobatinib (K0706) capsules once daily 174mg
BG016
Part C: Dose Level 1
Part C: Oral vodobatinib (K0706) capsules at 90mg once daily
BG017
Part C: Dose Level 2 (CML-AP)
Part C: Oral vodobatinib (K0706) capsules at 174mg, once daily.
BG018
Part C: Dose Level 2 (CML-CP)
Part C: Oral vodobatinib (K0706) capsules at 174mg, once daily.
BG019
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0016
BG0026
BG0036
BG0048
BG0058
BG0061
BG0071
BG0086
BG0097
BG0103
BG0117
BG01215
BG0136
BG0143
BG01512
BG0161
BG0175
BG01817
BG019124
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
Count of Participants
Participants
Title
Denominators
Categories
Age
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
Count of Participants
Participants
Title
Denominators
Categories
Sex: Female, Male
Title
Measurements
Female
BG0000
BG0010
BG002
Ethnicity (NIH/OMB)
This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
Count of Participants
Participants
Title
Denominators
Categories
Ethnicity
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG002
Race (NIH/OMB)
This is a Phase 1/2 study of K0706 consisting of Parts A, B, and C.
Count of Participants
Participants
Title
Denominators
Categories
Race
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
South Korea
Title
Measurements
BG0000
BG0010
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
Examination of the Safety and Tolerability of Single Oral Doses of K0706
Number of Participants with Adverse Events in Part A
Safety Analysis Set
Posted
Count of Participants
Participants
Approximately 56 ± 2 days
ID
Title
Description
OG000
Part A: Dose Level 1 (SAD Study)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 6mg
OG001
Part A: Dose Level 2 (SAD Study)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 12mg
OG002
Part A: Dose Level 3 (SAD Study)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 24mg
OG003
Part A: Placebo
Oral Placebo capsules
OG004
Part A: Dose Level 1 (FE Study)
Oral vodobatinib (K0706) capsules of 6mg
OG005
Part A: Dose Level 2 (FE Study)
Oral vodobatinib (K0706) capsules of 24mg
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0013
OG0024
OG003
Primary
To Determine the Maximum Tolerated Dose (MTD) as Determined by Frequency of Dose Limiting Toxicities
PART B
Safety Analysis Set
Posted
Count of Participants
Participants
Dose Limiting toxicities observed over a 4 week period
ID
Title
Description
OG000
Part B: Dose Level 1 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
OG001
Part B: Dose Level 2 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
OG002
Part B: Dose Level 3 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
OG003
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
OG004
Part B: Dose Level 5 (ESC Study)
Primary
Incidence and Severity of Treatment Emergent AEs (PART B)
Number of Participants with treatment emergent Adverse Events in Part B
Safety Analysis Set
Posted
Count of Participants
Participants
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
ID
Title
Description
OG000
Part B: Dose Level 1 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 12mg, once daily
OG001
Part B: Dose Level 2 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 24mg, once daily
OG002
Part B: Dose Level 3 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 48mg, once daily
OG003
Part B: Dose Level 4 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses of 66mg, once daily
OG004
Primary
For CML Subjects in CP at Study Entry
PART C: Proportion of subjects achieving Major Cytogenetic Response [ defined as complete cytogenetic response (CCyR; 0% Ph+metaphases) or partial cytogenetic response (PCyR; 1-35% Ph+ metaphases)] as assessed by conventional Karyotyping of Bone marrow aspirate
Efficacy Analysis Set
Posted
Count of Participants
Participants
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
ID
Title
Description
OG000
Part C: Dose Level 1
Part C: Oral vodobatinib (K0706) capsules 90 mg once daily.
OG001
Part C: Dose Level 2
Oral vodobatinib (K0706) capsules at 174mg, once daily.
Units
Counts
Participants
OG000
Primary
For CML Subjects in AP at Study Entry
PART C: Proportion of subjects achieving Major Hematologic Response [ defined as complete hematologic response (CHR) or no evidence of leukemia (NEL)] as assessed by complete blood count of peripheral blood sample
Efficacy Analysis Set
Posted
Count of Participants
Participants
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
ID
Title
Description
OG000
Part C: Dose Level 1
Oral vodobatinib (K0706) capsules at 90mg, once daily.
OG001
Part C: Dose Level 2
Oral vodobatinib (K0706) capsules at 174mg, once daily.
Units
Counts
Participants
OG000
Primary
For CML Subjects in BP at Study Entry
PART C: Proportion of subjects achieving Major Hematologic Response [defined as complete hematologic response (CHR) or no evidence of leukemia (NEL)] as assessed by complete blood count of peripheral blood sample
No participants with CML-BP were enrolled; therefore, the number of participants recruited and analyzed is reported as zero.
Posted
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
ID
Title
Description
OG000
Part C: Dose Level 1
Oral vodobatinib (K0706) capsules at 90mg, once daily.
OG001
Part C: Dose Level 2
Oral vodobatinib (K0706) capsules at 174mg, once daily.
Units
Counts
Participants
OG000
Secondary
To Characterize the Pharmacokinetics (Cmax) of K0706 After Single Oral Doses in Healthy Male Subjects
Part A
Pharmacokinetic Analysis Set
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Approximately 28 ± 2 days
ID
Title
Description
OG000
Part A: Dose Level 1 (SAD Study)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 6 mg
OG001
Part A: Dose Level 2 (SAD Study)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 12 mg
OG002
Part A: Dose Level 3 (SAD Study)
Oral vodobatinib (K0706) capsules in single ascending doses 24mg
Units
Counts
Participants
OG000
Secondary
To Characterize the Pharmacokinetics of K0706 (Cmax) After Single Oral Doses in Fasted and Fed State in Healthy Male Subjects
Part A
Pharmacokinetic Analysis Set
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Approximately 28 ± 2 days
ID
Title
Description
OG000
Part A: Dose Level 1 (FE Study)
Part A: Oral vodobatinib (K0706) capsules of 6 mg
OG001
Part A: Dose Level 2 (FE Study)
Part A: Oral vodobatinib (K0706) capsules of 24mg
Units
Counts
Participants
OG000
Secondary
Pharmacokinetic Profile of K0706 - Cmax [The Maximum (Peak) Observed Drug Concentration After Dose Administration]
PART B
PK Analysis Set
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
ID
Title
Description
OG000
Part B: Dose Level 1 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 12mg
OG001
Part B: Dose Level 2 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 24mg
OG002
Part B: Dose Level 3 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 48mg
OG003
Part B: Dose Level 4 (ESC Study)
Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 66mg
Secondary
Pharmacokinetic Profile of Vodobatinib (K0706) - Tmax [The Time to Reach Maximum (Peak) Drug Concentration After Dose Administration]
PART B
PK Analysis Set
Posted
Median
Full Range
hours
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
ID
Title
Description
OG000
Part B: Dose Level 1 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, including 12mg once daily
OG001
Part B: Dose Level 2 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, including 24mg once daily
OG002
Part B: Dose Level 3 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, including 48mg once daily
OG003
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, including 66mg once daily
Secondary
Pharmacokinetic Profile of Vodobatinib (K0706) - AUC[0-tau] (AUC Over the Dosing Interval of 0-24 Hours).
PART B
PK Analysis Set
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ng/mL
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
ID
Title
Description
OG000
Part B: Dose Level 1 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, including 12mg once daily
OG001
Part B: Dose Level 2 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, including 24mg once daily
OG002
Part B: Dose Level 3 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, including 48mg once daily
OG003
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, including 66mg once daily
Secondary
In Subjects With CML- CP:Proportion of Subjects Achieving Complete Hematological Response as Assessed by Complete Blood Count of Peripheral Blood Sample
PART C
Efficacy Analysis Set
Posted
Count of Participants
Participants
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
ID
Title
Description
OG000
Part C: Dose Level 1
Oral vodobatinib (K0706) capsules 90mg once daily.
OG001
Part C: Dose Level 2
Oral vodobatinib (K0706) capsules 174mg once daily.
Units
Counts
Participants
OG000
Secondary
In Subjects With CML- CP:Proportion of Subjects Achieving Complete Cytogenetic Response as Assessed by Conventional Karyotyping of Bone Marrow Aspirate
PART C
Efficacy Analysis Set
Posted
Count of Participants
Participants
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
ID
Title
Description
OG000
Part C: Dose Level 1
Oral vodobatinib (K0706) capsules 90mg once daily.
OG001
Part C: Dose Level 2
Oral vodobatinib (K0706) capsules 174mg once daily.
Units
Counts
Participants
OG000
Secondary
In Subjects With CML- CP:Proportion of Subjects Achieving Major Molecular Response as Assessed by BCR-ABL Transcript Levels (BCR-ABL1 Ratio of ≤ 0.1%) in Peripheral Blood Using PCR (Polymerase Chain Reaction)
PART C
Efficacy Analysis Set
Posted
Count of Participants
Participants
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
ID
Title
Description
OG000
Part C: Dose Level 1
Part C: Oral vodobatinib (K0706) capsules 90mg once daily.
OG001
Part C: Dose Level 2
Oral vodobatinib (K0706) capsules 174mg once daily.
Units
Counts
Participants
OG000
Secondary
In Subjects With CML-AP & BP: Proportion of Subjects Achieving Complete Cytogenetic Response as Assessed by Conventional Karyotyping of Bone Marrow Aspirate
PART C
Efficacy Analysis Set
Posted
Count of Participants
Participants
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
ID
Title
Description
OG000
Part C: Dose Level 1
Oral vodobatinib (K0706) capsules 90mg once daily.
OG001
Part C: Dose Level 2
Oral vodobatinib (K0706) capsules 174mg once daily.
Units
Counts
Participants
OG000
Secondary
In Subjects With CML-AP & BP: Proportion of Subjects Achieving Partial Cytogenetic Response (PCyR) as Assessed by Conventional Karyotyping of Bone Marrow Aspirate
Part C
Efficacy Analysis Set
Posted
Count of Participants
Participants
All subjects will be followed up for 60 months from the first dose of K0706
ID
Title
Description
OG000
Part C: Dose Level 1
Oral vodobatinib (K0706) capsules 90mg once daily.
OG001
Part C: Dose Level 2
Oral vodobatinib (K0706) capsules 174mg once daily.
Units
Counts
Participants
OG000
Secondary
In Subjects With CML-AP & BP: Proportion of Subjects Achieving Major Molecular Response as Assessed by BCR-ABL Transcript Levels (BCR-ABL1 Ratio of ≤ 0.1%) in Peripheral Blood Using PCR (Polymerase Chain Reaction)
PART C
Efficacy Analysis Set
Posted
Count of Participants
Participants
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
ID
Title
Description
OG000
Part C: Dose Level 1
Part C: Oral vodobatinib (K0706) capsules 90mg once daily.
OG001
Part C: Dose Level 2
Part C: Oral vodobatinib (K0706) capsules 174mg once daily.
Units
Counts
Participants
OG000
Secondary
Time to Major Cytogenetic Response (MCyR): Time to MCyR is the Time From First Dose to First MCyR (0-35% Ph+ Metaphases); Computed Only for CML-CP Subjects Who Achieved MCyR
PART C; Time to response was calculated as time from date of first dose to date of first occurrence of best response
Efficacy Analysis Set (Cycle 2; Time to MCyR differs from the proportion achieving MCyR because it is a time-to-event endpoint calculated only for subjects who achieved MCyR, whereas the proportion endpoint includes all evaluable subjects and reflects whether MCyR was achieved at any time.)
Posted
Mean
Standard Error
months
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
ID
Title
Description
OG000
Part C: Dose Level 1
Part C: Oral vodobatinib (K0706) capsules 90mg once daily.
OG001
Part C: Dose Level 2
Part C: Oral vodobatinib (K0706) capsules 174mg once daily.
Units
Counts
Participants
Secondary
Time to Major Molecular Response : Time to MMR is the Time From First Dose to First MMR (BCR-ABL1 Ratio of ≤ 0.1%) Computed Only for CML-CP Subjects Who Achieved MMR
PART C; Time to response was calculated as time from date of first dose to date of first occurrence of best response
Efficacy Analysis Set
Posted
Mean
Standard Deviation
months
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
ID
Title
Description
OG000
Part C: Dose Level 1
Part C: Oral vodobatinib (K0706) capsules 90mg once daily.
OG001
Part C: Dose Level 2
Part C: Oral vodobatinib (K0706) capsules 174mg once daily.
Units
Counts
Participants
OG000
Secondary
In All Subjects Progression Free Survival (PFS)
PART C
Safety Analysis Set
Posted
Number
95% Confidence Interval
percentage of participants
All subjects will be followed up at 12, 24, 36 months from the first dose of K0706 and beyond, until intolerance, disease progression or subject withdrawal from the study.
ID
Title
Description
OG000
Part C: Dose Level 1
Part C: Oral vodobatinib (K0706) capsules 90mg once daily.
OG001
Part C: Dose Level 2
Part C: Oral vodobatinib (K0706) capsules 174mg once daily.
Units
Counts
Participants
OG000
Secondary
In All Subjects Overall Survival (OS)
PART C
Safety Analysis Set
Posted
Number
95% Confidence Interval
percentage of participants
All subjects will be followed up at 12, 24, 36 months from the first dose of K0706 and beyond, until intolerance, disease progression or subject withdrawal from the study.
ID
Title
Description
OG000
Part C: Dose Level 1
Part C: Oral vodobatinib (K0706) capsules 90mg once daily.
OG001
Part C: Dose Level 2
Part C: Oral vodobatinib (K0706) capsules 174mg once daily.
Units
Counts
Participants
OG000
Secondary
Incidence and Severity of Treatment Emergent AEs (PART C)
Number of Participants with treatment emergent Adverse Events in Part C
Safety Analysis Set
Posted
Count of Participants
Participants
All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
ID
Title
Description
OG000
Part C: Dose Level 1
Oral vodobatinib (K0706) capsules 90mg once daily
OG001
Part C: Dose Level 2
Oral vodobatinib (K0706) capsules 174mg once daily
Units
Counts
Participants
OG000
Secondary
Pharmacokinetic Profile of K0706 - Cmax [The Maximum (Peak) Observed Drug Concentration After Dose Administration]
PART C
PK Analysis Set; No pharmacokinetic data were collected for the 90mg cohort because the subject did not attend the scheduled visit, and therefore pharmacokinetic blood samples were not obtained.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
ID
Title
Description
OG000
Part C: Dose Level 1
Oral vodobatinib (K0706) capsules 90mg once daily
OG001
Part C: Dose Level 2
Oral vodobatinib (K0706) capsules174mg once daily
Units
Counts
Participants
OG000
Secondary
Pharmacokinetic Profile of Vodobatinib (K0706) - Tmax [The Time to Reach Maximum (Peak) Drug Concentration After Dose Administration]
PART C
PK Analysis Set; No pharmacokinetic data were collected for the 90mg cohort because the subject did not attend the scheduled visit, and therefore pharmacokinetic blood samples were not obtained.
Posted
Median
Full Range
hours
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
ID
Title
Description
OG000
Part C: Dose Level 1
Oral vodobatinib (K0706) capsules 90mg once daily
OG001
Part C: Dose Level 2
Oral vodobatinib (K0706) capsules 174mg once daily
Units
Counts
Participants
OG000
Secondary
To Characterize the Pharmacokinetics (AUC(0-inf)) of K0706 After Single Oral Doses in Healthy Male Subjects
Part A
Pharmacokinetic Analysis Set
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Approximately 28 ± 2 days
ID
Title
Description
OG000
Part A: Dose Level 1 (SAD Study)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 6mg
OG001
Part A: Dose Level 2 (SAD Study)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 12mg
OG002
Part A: Dose Level 3 (SAD Study)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 24mg
Units
Counts
Participants
OG000
Secondary
To Characterize the Pharmacokinetics of K0706 (AUC(0-inf)) After Single Oral Doses in Fasted and Fed State in Healthy Male Subjects
Part A
Pharmacokinetic Analysis Set
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/mL
Approximately 28 ± 2 days
ID
Title
Description
OG000
Part A: Dose Level 1 (FE Study)
Part A: Oral vodobatinib (K0706) capsules at 6mg
OG001
Part A: Dose Level 2 (FE Study)
Part A: Oral vodobatinib (K0706) capsules at 24mg
Units
Counts
Participants
OG000
Time Frame
Adverse events will be assessed throughout the study until 30 days after discontinuation of the study drug. Subjects will remain on study treatment for approximately 60 months. All subjects will be followed up for up to 60 months from the first dose of Vodobatinib (K0706), unless subject discontinues due to intolerance or progression of disease.
Description
Adverse event (AE) reporting period for safety surveillance begins after subject is randomized into the study and receives at least 1 dose of the investigational medicinal product (IMP) for treatment emergent adverse events (TEAEs) and continues until 30 days from end of treatment visit. Any AE which occurs 30 days after end of treatment visit or last dose of IMP will be reported if it is considered related to IMP/study procedure by the investigator.
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
Part A: Dose Level 1 (SAD Study)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 6mg
0
6
0
6
1
6
EG001
Part A: Dose Level 2 (SAD Study)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 12mg
0
6
0
6
3
6
EG002
Part A: Dose Level 3 (SAD Study)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 24mg
0
6
0
6
4
6
EG003
Part A: Placebo (SAD Study)
Part A: Oral placebo capsules
0
6
0
6
2
6
EG004
Part A: Dose Level 1 (FE Study)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 6mg
0
8
0
8
4
8
EG005
Part A: Dose Level 2 (FE Study)
Part A: Oral vodobatinib (K0706) capsules in single ascending doses of 24mg
0
8
0
8
3
8
EG006
Part B: Dose Level 1 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 12mg
0
1
0
1
1
1
EG007
Part B: Dose Level 2 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 24mg
0
1
0
1
1
1
EG008
Part B: Dose Level 3 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 48mg
1
6
2
6
6
6
EG009
Part B: Dose Level 4 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 66mg
0
7
3
7
7
7
EG010
Part B: Dose Level 5 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 90mg
0
3
0
3
3
3
EG011
Part B: Dose Level 6 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 126mg
1
7
4
7
7
7
EG012
Part B: Dose Level 7 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 174mg
1
15
3
15
13
15
EG013
Part B: Dose Level 8 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 204mg
1
6
4
6
6
6
EG014
Part B: Dose Level 9 (ESC Study)
Part B: Oral vodobatinib (K0706) capsules in multiple ascending doses, once daily, including 240mg
0
3
3
3
3
3
EG015
Part B: Dose Level 1 (EXP Study)
Part B: Oral vodobatinib (K0706) capsules at 174 mg once daily
1
12
2
12
10
12
EG016
Part C: Dose Level 1
Part C: Oral vodobatinib (K0706) capsules at 90mg once daily
0
1
0
1
1
1
EG017
Part C: Dose Level 2
Part C: Oral vodobatinib (K0706) capsules 174mg, once daily
3
22
6
22
20
22
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pneumonia
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected6 at risk
EG0091 events1 affected7 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected15 at risk
EG0131 events1 affected6 at risk
EG0140 events0 affected3 at risk
EG0150 events0 affected12 at risk
EG0160 events0 affected1 at risk
EG0171 events1 affected22 at risk
Urinary tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
COVID-19
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Skin infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Suspected COVID-19
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Amnesia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dementia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypoxic-ischaemic encephalopathy
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Disease progression
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Sudden death
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Varices oesophageal
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Chronic myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Septic shock
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Swollen tongue
Immune system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Skull fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary toxicity
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected8 at risk
EG0061 events1 affected1 at risk
EG0070 events0 affected1 at risk
EG0083 events3 affected6 at risk
EG0090 events0 affected7 at risk
EG0100 events0 affected3 at risk
EG0111 events1 affected7 at risk
EG0122 events2 affected15 at risk
EG0130 events0 affected6 at risk
EG0140 events0 affected3 at risk
EG0151 events1 affected12 at risk
EG0160 events0 affected1 at risk
EG0174 events4 affected22 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
COVID-19
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Periodontitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Anal abscess
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Enteritis infectious
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Eye infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Eyelid infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Fungal foot infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Human polyomavirus infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Skin infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Suspected COVID-19
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Tinea infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Chronic gastritis
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Intestinal atony
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Noninfective gingivitis
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Tongue coated
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Tooth loss
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Varices oesophageal
Gastrointestinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hyperleukocytosis
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Polycythaemia
Blood and lymphatic system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Gouty arthritis
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Asthenia
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Chest pain
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Disease progression
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Influenza like illness
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pain
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Swelling face
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cyst
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Drug withdrawal syndrome
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Face oedema
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Generalised oedema
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Sudden death
General disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Lipase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Amylase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Platelet count decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Weight decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Weight increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
International normalised ratio increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Intestinal transit time decreased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Troponin I increased
Investigations
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Folate deficiency
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypouricaemia
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypovitaminosis
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Tetany
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Prurigo
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rash vesicular
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected6 at risk
EG0022 events2 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Amnesia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Bell's palsy
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Sciatica
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vertigo
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Anosmia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dementia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dyskinesia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Motor dysfunction
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Syncope
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Bronchial disorder
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary toxicity
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vocal cord thickening
Respiratory, thoracic and mediastinal disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hot flush
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Intermittent claudication
Vascular disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Post procedural oedema
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Post-traumatic pain
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Skull fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Tooth injury
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Traumatic haematoma
Injury, poisoning and procedural complications
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Agitation
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Polydipsia psychogenic
Psychiatric disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vision blurred
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dry eye
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Eye irritation
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Miosis
Eye disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nephropathy
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nephrotic syndrome
Renal and urinary disorders
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Acute lymphocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Chronic myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (26.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Skin cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)