PKC412 in Participants With Acute Myeloid Leukemia or Wit... | NCT00045942 | Trialant
NCT00045942
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Aug 11, 2017Actual
Enrollment
144Actual
Phase
Phase 1Phase 2
Conditions
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Interventions
Itraconazole
PKC412
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00045942
Obsolete or Duplicate NCT IDs
NCT00045578
NCT00977782
Organization Study
CPKC412A2104
Secondary IDs
Not provided
Brief Title
PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome (CPKC412A2104 Core); and PKC412 in Participants With Acute Myeloid Leukemia or With Myelodysplastic Syndrome With Either Wild Type or Mutated FMS-like Tyrosine Kinase 3 (FLT3) (CPKC412A2104E1 and CPKC412A2104E2)
Official Title
An Open-label Phase II (Proof of Concept (POC)) Trial of PKC412 Monotherapy in Participants With Acute Myeloid Leukemia (AML) and Participants With High Risk Myelodysplastic Syndrome (MDS) (CPKC412A2104 Core); An Open-label, Randomized Phase II POC Trial in PKC412 in Participants With AML and Participants With High Risk MDS With Either Wild Type or Mutated FLT3 (CPKC412A2104E1); and An Open-label, Randomized Phase 1/II POC Trial in PKC412 in Participants With AML and Participants With High Risk MDS With Either Wild Type or Mutated FLT3 (CPKC412A2104E2)
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Aug 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 30, 2002Actual
Primary Completion Date
Mar 27, 2008Actual
Completion Date
Mar 27, 2008Actual
First Submitted Date
Sep 16, 2002
First Submission Date that Met QC Criteria
Sep 17, 2002
First Posted Date
Sep 18, 2002Estimated
Results Waived
Not provided
Results First Submitted Date
May 3, 2017
Results First Submitted that Met QC Criteria
Jun 15, 2017
Results First Posted Date
Jul 17, 2017Actual
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
Aug 7, 2017
Last Update Posted Date
Aug 11, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
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
CPKC412A2104 core had a 2 stage design. In stage 1, eight participants were treated. If at least one participant showed a clinical response, four more participants were recruited to stage 2. The trial was to be stopped if no participants showed a response in stage 1. POC was achieved if at least 2 participants out of 12 responded. In PKC412A2104E1, participants with AML or high risk MDS with wild-type or mutant FTL3 who had not previously received a FLT3 inhibitor were randomized to receive continuous twice daily oral doses of either 50 or 100 mg midostaurin in 1 28-day cycle regimen. Participants were to be treated until disease progression or the occurrence of unacceptable treatment-related toxicity. PKC412A2104 E2 contained 2 dosing regimens: 1) intra-participant midostaurin dose escalation and 2) midostaurin with itraconazole in participants with AML and high risk MDS irrespective of FLT3 status. Eligible participants were alternately assigned to the regimens. At the Investigator's discretion, intra-participant dose escalation was allowed for any previously enrolled CPKC412A2104E1 participant receiving midostaurin at the time of the approval of amendment 4. Participants were treated until the time of disease progression.
Detailed Description
Not provided
Conditions Module
Conditions
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Keywords
AML
MDS
high risk myelodysplastic syndrome
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
144Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
PKC412 (Core)
Experimental
Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Drug: PKC412
FLT3 mutated PKC412 100 mg/day (E1)
Experimental
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Drug: PKC412
FLT3 mutated PKC412 200 mg/day (E1)
Experimental
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Drug: PKC412
FLT3 wild type PKC412 100 mg/day (E1)
Experimental
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Drug: PKC412
FLT3 wild type PKC412 200 mg/day (E1)
Experimental
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Itraconazole
Drug
Itraconazole was commercially available.
FLT3 mutated PKC+Itraconazole (E2)
FLT3 wild type PKC+Itraconazole (E2)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Best Clinical Response (Core)
Best clinical response was defined as complete response (CR) or partial response (PR), according to NCI definitions for AML and the guidelines for defining responses in MDS.
from date of first patient first visit (FPFV), 29-Jan-2002, to date of last participant last visit (LPLV), 04-Sep-2003
Percent Decrease in Phospho-FLT3 Compared to Baseline (Core)
days 1, 28
Number of Participants With Overall Clinical Response (E1)
Overall clinical response was defined as CR, PR, minor response (MR) or blast response (BR). CR and PR was defined according to NCI definitions, and MR and BR was defined according to the guidelines for defining hematologic improvement in MDS.
from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004
Percent Decrease in Phospho-FLT3 Compared to Baseline (E1)
days 1, 28
Percent Decrease in Phospho-FLT3 Compared to Baseline (E2)
Days 1, 28
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for PKC412 Plasma in the PKC + Itraconazole Combination Arm (E2)
Blood samples were collected for pharmacokinetic (PK) analysis.
Cycle 1: days 21, 22, 28
Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax) for PKC412 in the PKC + Itraconazole Combination Arm (E2)
Blood samples were collected for pharmacokinetic (PK) analysis.
Secondary Outcomes
Measure
Description
Time Frame
Time to Disease Progression (TTP) (Core)
TTP was defined as the time from first dose date to date of disease progression which is identified as study completion date for unsatisfactory treatment effect or date of death from any cause within the 28 day cutoff post treatment.
from date of FPFV, 29-Jan-2002, to date of LPLV, 04-Sep-2003
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Patients:
with AML who are not candidates for myelosuppressive chemotherapy or with AML who have relapsed disease or are refractory to standard therapy and not likely to require cytoreductive therapy within one month or with MDS subtypes refractory anemia with excess blasts (RAEB), RAEB in transformation (RAEB-T) or chronic myelomonocytic leukemia (CMML).
Patients with a relevant FLT3-ITD mutation or D835Y point mutation
Patients at least 18 years or older
Patients with WHO performance status of 0 to 2 with a life expectancy of at least 3 months
Patients must not be treated within 4 weeks after any prior therapy
Written informed consent obtained according to local guidelines
Exclusion criteria:
Patients meeting any of the following criteria during screening will be excluded from entry into the study:
Patients who had prior allogeneic, syngeneic, or autologous bone marrow transplant or stem cell transplant less than 2 months previously.
Female patients who are pregnant or breast feeding, or adults of childbearing age not employing an effective method of birth control.
Concurrent severe and/or uncontrolled medical or psychiatric condition which may interfere with the completion of the study.
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PKC412.
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
Name
Affiliation
Role
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
UCLA Medical Center
Los Angeles
California
90095
United States
Dana-Farber Cancer Institute
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Undecided
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
In PKC412A2104E2, participants were alternately assigned to the regimens, beginning with the first enrolled into the intra-patient dose escalation arm and the next enrolled into the PKC412 + itraconazole arm. Of the 16 participants enrolled in the PKC412 dose escalation arm, 14 were newly enrolled, and 2 were transitioned from PKC412A2104E1.
Recruitment Details
In PKC412A2104 (Core), FLT3 mutated participants with AML or MDS received open-label PKC412. In PKC412A2104E1, FLT3 mutated participants and FLT3 wild type participants were randomized to receive either PKC412 50 mg bid or PKC412 100 mg bid.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
PKC412 in FLT3 Mutated Participants (Core)
Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
FG001
FLT3 Mutated PKC412 100 mg/Day (E1)
Periods
Title
Milestones
Reasons Not Completed
PKC412A2104 (Core)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: PKC412
FLT3 mutated PKC412 dose escalation
Experimental
Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
Drug: PKC412
FLT3 mutated PKC+Itraconazole (E2)
Experimental
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Drug: Itraconazole
Drug: PKC412
FLT3 wild type PKC412 dose escalation (E2)
Experimental
Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
Drug: PKC412
FLT3 wild type PKC+Itraconazole (E2)
Experimental
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Drug: Itraconazole
Drug: PKC412
PKC412
Drug
PKC412 was supplied as soft gelatin capsules containing 25 mg PKC412.
FLT3 mutated PKC+Itraconazole (E2)
FLT3 mutated PKC412 100 mg/day (E1)
FLT3 mutated PKC412 200 mg/day (E1)
FLT3 mutated PKC412 dose escalation
FLT3 wild type PKC+Itraconazole (E2)
FLT3 wild type PKC412 100 mg/day (E1)
FLT3 wild type PKC412 200 mg/day (E1)
FLT3 wild type PKC412 dose escalation (E2)
PKC412 (Core)
Midostaurin
Cycle 1: days 21, 22, 28
Time to Reach the Maximum Concentration After Drug Administration (Tmax) for PKC412 in the PKC412 + Itraconazole Combination Arm (E2)
Blood samples were collected for PK analysis.
Cycle 1: days 21, 22, 28
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for PKC412 in the PKC412 + Itraconazole Combination Arm (E2)
Blood samples were collected for PK analysis.
Cycle 1: days 21, 22, 28
Terminal Elimination Half-life (T1/2) for PKC412 in the PKC + Itrconazole Combination Arm (E2)
Blood samples were collected for PK analysis.
Cycle 1: days 21 and 22
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for CGP62221 Plasma in the PKC + Itraconazole Combination Arm (E2)
Blood samples were collected for pharmacokinetic (PK) analysis.
Cycle 1: days 21, 22, 28
Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax) for CGP62221 in the PKC + Itraconazole Combination Arm (E2)
Blood samples were collected for pharmacokinetic (PK) analysis.
Cycle 1: days 21, 22, 28
Time to Reach the Maximum Concentration After Drug Administration (Tmax) for CGP62221 in the PKC412 + Itraconazole Combination Arm (E2)
Blood samples were collected for PK analysis.
Cycle 1: days 21, 22, 28
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for CGP622221 in the PKC412 + Itraconazole Combination Arm (E2)
Blood samples were collected for PK analysis.
Cycle 1: days 21, 22, 28
Terminal Elimination Half-life (T1/2) for CGP62221 in the PKC + Itrconazole Combination Arm (E2)
Blood samples were collected for PK analysis.
Cycle 1: day 22,
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for CGP52421 Plasma in the PKC + Itraconazole Combination Arm (E2)
Blood samples were collected for pharmacokinetic (PK) analysis.
Cycle 1: days 21, 22, 28
Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax) for CGP52421 in the PKC + Itraconazole Combination Arm (E2)
Blood samples were collected for pharmacokinetic (PK) analysis.
Cycle 1: days 21, 22, 28
Time to Reach the Maximum Concentration After Drug Administration (Tmax) for CGP52421 in the PKC412 + Itraconazole Combination Arm (E2)
Blood samples were collected for PK analysis.
Cycle 1: days 21, 22, 28
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for CGP52421 in the PKC412 + Itraconazole Combination Arm (E2)
Blood samples were collected for PK analysis.
Cycle 1: days 21, 22, 28
Summary of Midostaurin Concentration in the PKC412 Dose Escalation Arms(E2)
Blood samples were collected for analysis.
Cycle 1: days 1, 2 (24 hr post day 1), 3, 8, 15, 16 (24 hr post day 15), 17, 22; Cycle 2: days 1, 2 (24 hr post day 1), 3, 8, 15
Summary of CGP62221 Concentration (E2)
Blood samples were collected for analysis.
Cycle 1: days 1, 2 (24 hr post day 1), 3, 8, 15, 16 (24 hr post day 15), 17, 22; Cycle 2: days 1, 2 (24 hr post day 1), 3, 8, 15
Summary of CGP52421 Concentration (E2)
Blood samples were collected for analysis.
Cycle 1: days 1, 2 (24 hr post day 1), 3, 8, 15, 16 (24 hr post day 15), 17, 22; Cycle 2: days 1, 2 (24 hr post day 1), 3, 8, 15
Summary of Midostaurin Plasma Concentration (Core)
Blood samples were collected for analysis.
Cycle 1: days 1 (24 hour), 3, 8; Cycle 2: day 1,
Summary of CGP62221 Plasma Concentration (Core)
Blood samples were collected for analysis.
Cycle 1: days 1 (24 hour), 3, 8; Cycle 2: day 1,
Summary of CGP52421 Plasma Concentration (Core)
Blood samples were collected for analysis.
Cycle 1: days 1 (24 hour), 3, 8; Cycle 2: day 1,
Time to Disease Progression (E1)
TTP was defined as the time from the first dose date to the date of disease progression (defined as the study completion date for unsatisfactory treatment effect, date of response assessment of progressive disease, or date of death from any cause). One participant from the wild type 200 mg group did not have any assessment on treatment and therefore was not taken into account for TTP.
from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004
Overall Survival (OS) (E1)
OS was measured from the date of the first dose of treatment to the date of death from any cause or to the last date that the patient was known to be alive (a censored observation).
from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004
Duration of Best Clinical Response (E1)
Duration of best clinical response was measured from the time that the measurement criteria were met for CR, PR, MR (with or without blast reduction) or BR until the first date that recurrent disease was documented (event) or until the date of last follow up.
from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004
Event-free Survival (E1)
Event-free survival was defined as the time from date of start of treatment to the date of death from any cause, treatment failure or relapse
from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004
Summary of PKC412 Plasma Concentration for 50 mg Twice Daily (Bid) Arm (E1)
Blood samples were collected for analysis.
Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h)
Summary of CGP62221 Plasma Concentration for 50 mg Bid Arm (E1)
Blood samples were collected for analysis.
Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h)
Summary of CGP52421 Plasma Concentration for 50 mg Bid Arm (E1)
Blood samples were collected for analysis.
Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h)
Summary of PKC412 Plasma Concentration for 100 mg Bid Arm (E1)
Blood samples were collected for analysis.
Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h); cycle 5: day 1 (0h) and cycle 6: day 1 (0h)
Summary of CGP62221 Plasma Concentration for 100 mg Bid Arm (E1)
Blood samples were collected for analysis.
Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h); cycle 5: day 1 (0h) and cycle 6: day 1 (0h)
Summary of CGP52421 Plasma Concentration for 100 mg Bid Arm (E1)
Blood samples were collected for analysis.
Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h); cycle 5: day 1 (0h) and cycle 6: day 1 (0h)
Best Clinical Response (E2)
Best clinical response was defined as CR, PR, MR, MR+BR, or BR . CR and PR was defined according to NCI definitions, and MR and BR was defined according to the guidelines for defining hematologic improvement in MDS.
date of FPFV, 21-Aug-2003, to date of LPLV, 27-Mar-2008
Time to Disease Progression (E2)
TTP was defined as the time from the first dose date to the date of disease progression, which was defined as the study completion date for unsatisfactory treatment effect, the date of response assessment of progressive disease, or the date of death from any cause
date of FPFV, 21-Aug-2003, to date of LPLV, 27-Mar-2008
Overall Survival (E2)
OS was measured from the date of the first dose of treatment to the date of death from any cause or the last date the patient was known to be alive (censored observation)
date of FPFV, 21-Aug-2003, to date of LPLV, 27-Mar-2008
Boston
Massachusetts
02115
United States
New York Weill Cornell Medical Center
New York
New York
10021
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
FG002
FLT3 Mutated PKC412 200 mg/Day (E1)
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
FG003
FLT3 Wild Type PKC412 100 mg/Day (E1)
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
FG004
FLT3 Wild Type PKC412 200 mg/Day (E1)
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
FG005
FLT3 Mutated PKC412 Dose Escalation (E2)
Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
FG006
FLT3 Mutated PKC+Itraconazole (E2)
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
FG007
FLT3 Wild Type PKC412 Dose Escalation (E2)
Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
FG008
FLT3 Wild Type PKC+Itraconazole (E2)
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
FG00020 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Core Primary Efficacy
FG00020 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
NOT COMPLETED
FG00020 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Adverse Event
FG0005 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG00013 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
PKC412A2104E1
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG00118 subjects
FG00217 subjects
FG00333 subjects
FG00427 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Primary Efficacy
FG0000 subjects
FG00118 subjects
FG00217 subjects
FG00332 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG00118 subjects
FG00217 subjects
FG00333 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG003
PKC412A2104E2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0059 subjects
FG0067 subjects
FG0077 subjects
FG0086 subjects
Primary Efficacy
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
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
The baseline characteristics for PKC412A2104E2 do not include data for the 2 patients who transferred from CPKC412A2104E1 since the data for these 2 patients are included under CPKC412A2104E1.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
PKC412 in FLT3 Mutated Participants (Core)
Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
BG001
FLT3 Mutated PKC412 100 mg/Day (E1)
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
BG002
FLT3 Mutated PKC412 200 mg/Day (E1)
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
BG003
FLT3 Wild Type PKC412 100 mg/Day (E1)
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
BG004
FLT3 Wild Type PKC412 200 mg/Day (E1)
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
BG005
FLT3 Mutated PKC412 Dose Escalation (E2)
Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
BG006
FLT3 Mutated PKC+Itraconazole (E2)
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
BG007
FLT3 Wild Type PKC412 Dose Escalation (E2)
Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
BG008
FLT3 Wild Type PKC+Itraconazole (E2)
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00020
BG00118
BG00217
BG00333
BG00427
BG0058
BG0067
BG0076
BG0086
BG009142
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG0015
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Best Clinical Response (Core)
Best clinical response was defined as complete response (CR) or partial response (PR), according to NCI definitions for AML and the guidelines for defining responses in MDS.
Core primary efficacy population: The core primary efficacy population included all participants who were randomized.
Posted
Number
Participants
from date of first patient first visit (FPFV), 29-Jan-2002, to date of last participant last visit (LPLV), 04-Sep-2003
ID
Title
Description
OG000
PKC412 in FLT3 Mutated Participants (Core)
Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Units
Counts
Participants
OG00020
Title
Denominators
Categories
Title
Measurements
OG0000
Primary
Percent Decrease in Phospho-FLT3 Compared to Baseline (Core)
This outcome measure was not analyzed. Assessment of FLT3 autophosphorylation in leukemic blasts was not possible at the planned time points because the blast reduction was rapid and occurred during the first week in some participants. Thus, by Day 28, the blast count in some participants were too low for autophosphorylation to be measured.
Posted
days 1, 28
ID
Title
Description
OG000
PKC412 in FLT3 Mutated Participants (Core)
Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Units
Counts
Participants
OG000
Primary
Number of Participants With Overall Clinical Response (E1)
Overall clinical response was defined as CR, PR, minor response (MR) or blast response (BR). CR and PR was defined according to NCI definitions, and MR and BR was defined according to the guidelines for defining hematologic improvement in MDS.
E1 primary efficacy population: all participants who received at least one dose of study medication, completed at least 8 days of therapy within Cycle 1 unless discontinued due to progressive disease and/or death due to any cause, and who were not considered to be associated with a protocol violation that was exclusionary from the population.
Posted
Number
Participants
from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004
ID
Title
Description
OG000
FLT3 Mutated PKC412 100 mg/Day (E1)
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
OG001
FLT3 Mutated PKC412 200 mg/Day (E1)
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
OG002
FLT3 Wild Type PKC412 100 mg/Day (E1)
Primary
Percent Decrease in Phospho-FLT3 Compared to Baseline (E1)
The analyses for this outcome measure were not performed due to technical challenges in measuring phosphorylated FLT3 in patient blast samples in an ex vivo setting.
Posted
days 1, 28
ID
Title
Description
OG000
FLT3 Mutated PKC412 100 mg/Day (E1)
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
OG001
FLT3 Mutated PKC412 200 mg/Day (E1)
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
OG002
FLT3 Wild Type PKC412 100 mg/Day (E1)
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
OG003
FLT3 Wild Type PKC412 200 mg/Day (E1)
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Primary
Percent Decrease in Phospho-FLT3 Compared to Baseline (E2)
The analyses for this outcome measure were not performed due to technical challenges in measuring phosphorylated FLT3 in patient blast samples in an ex vivo setting.
Posted
Days 1, 28
ID
Title
Description
OG000
FLT3 Mutated PKC412 Dose Escalation (E2)
Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
OG001
FLT3 Mutated PKC+Itraconazole (E2)
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
OG002
FLT3 Wild Type PKC412 Dose Escalation (E2)
Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
Primary
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for PKC412 Plasma in the PKC + Itraconazole Combination Arm (E2)
Blood samples were collected for pharmacokinetic (PK) analysis.
The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.
Posted
Mean
Standard Deviation
h*ng/ml
Cycle 1: days 21, 22, 28
ID
Title
Description
OG000
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Units
Counts
Participants
OG000
Primary
Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax) for PKC412 in the PKC + Itraconazole Combination Arm (E2)
Blood samples were collected for pharmacokinetic (PK) analysis.
The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.
Posted
Mean
Standard Deviation
ng/ml
Cycle 1: days 21, 22, 28
ID
Title
Description
OG000
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Units
Counts
Participants
OG000
Primary
Time to Reach the Maximum Concentration After Drug Administration (Tmax) for PKC412 in the PKC412 + Itraconazole Combination Arm (E2)
Blood samples were collected for PK analysis.
The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.
Posted
Median
Full Range
hour
Cycle 1: days 21, 22, 28
ID
Title
Description
OG000
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Units
Counts
Participants
OG000
Primary
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for PKC412 in the PKC412 + Itraconazole Combination Arm (E2)
Blood samples were collected for PK analysis.
The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.
Posted
Mean
Standard Deviation
h*ng/ml
Cycle 1: days 21, 22, 28
ID
Title
Description
OG000
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Units
Counts
Participants
OG000
Primary
Terminal Elimination Half-life (T1/2) for PKC412 in the PKC + Itrconazole Combination Arm (E2)
Blood samples were collected for PK analysis.
The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.
Posted
Mean
Standard Deviation
hour
Cycle 1: days 21 and 22
ID
Title
Description
OG000
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Units
Counts
Participants
OG000
Primary
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for CGP62221 Plasma in the PKC + Itraconazole Combination Arm (E2)
Blood samples were collected for pharmacokinetic (PK) analysis.
The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.
Posted
Mean
Standard Deviation
h*ng/ml
Cycle 1: days 21, 22, 28
ID
Title
Description
OG000
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Units
Counts
Participants
OG000
Primary
Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax) for CGP62221 in the PKC + Itraconazole Combination Arm (E2)
Blood samples were collected for pharmacokinetic (PK) analysis.
The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.
Posted
Mean
Standard Deviation
ng/ml
Cycle 1: days 21, 22, 28
ID
Title
Description
OG000
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Units
Counts
Participants
OG000
Primary
Time to Reach the Maximum Concentration After Drug Administration (Tmax) for CGP62221 in the PKC412 + Itraconazole Combination Arm (E2)
Blood samples were collected for PK analysis.
The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.
Posted
Median
Full Range
hour
Cycle 1: days 21, 22, 28
ID
Title
Description
OG000
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Units
Counts
Participants
OG000
Primary
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for CGP622221 in the PKC412 + Itraconazole Combination Arm (E2)
Blood samples were collected for PK analysis.
The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.
Posted
Mean
Standard Deviation
h*ng/ml
Cycle 1: days 21, 22, 28
ID
Title
Description
OG000
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Units
Counts
Participants
OG000
Primary
Terminal Elimination Half-life (T1/2) for CGP62221 in the PKC + Itrconazole Combination Arm (E2)
Blood samples were collected for PK analysis.
The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For this end point, 4 participants with non-missing values were analyzed.
Posted
Mean
Standard Deviation
hour
Cycle 1: day 22,
ID
Title
Description
OG000
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Units
Counts
Participants
OG000
Primary
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for CGP52421 Plasma in the PKC + Itraconazole Combination Arm (E2)
Blood samples were collected for pharmacokinetic (PK) analysis.
The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.
Posted
Mean
Standard Deviation
h*ng/ml
Cycle 1: days 21, 22, 28
ID
Title
Description
OG000
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Units
Counts
Participants
OG000
Primary
Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax) for CGP52421 in the PKC + Itraconazole Combination Arm (E2)
Blood samples were collected for pharmacokinetic (PK) analysis.
The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.
Posted
Mean
Standard Deviation
ng/ml
Cycle 1: days 21, 22, 28
ID
Title
Description
OG000
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Units
Counts
Participants
OG000
Primary
Time to Reach the Maximum Concentration After Drug Administration (Tmax) for CGP52421 in the PKC412 + Itraconazole Combination Arm (E2)
Blood samples were collected for PK analysis.
The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.
Posted
Median
Full Range
hour
Cycle 1: days 21, 22, 28
ID
Title
Description
OG000
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Units
Counts
Participants
OG000
Primary
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for CGP52421 in the PKC412 + Itraconazole Combination Arm (E2)
Blood samples were collected for PK analysis.
The pharmacokinetic (PK) population in the midostaurin + itraconazole FLT3 mutated and FLT3 wild-type combined arms, which consisted of 10 participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.
Posted
Mean
Standard Deviation
h*ng/ml
Cycle 1: days 21, 22, 28
ID
Title
Description
OG000
FLT3 Mutated and FLT3 Wild Type PKC + Itraconazole Combined
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Units
Counts
Participants
OG000
Primary
Summary of Midostaurin Concentration in the PKC412 Dose Escalation Arms(E2)
Blood samples were collected for analysis.
The PK analysis set of the FLT3 mutated PKC412 dose escalation and FLT3 wild type PKC412 dose escalation combined arms, which consisted of the 14 newly enrolled participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.
Posted
Median
Full Range
ng/ml
Cycle 1: days 1, 2 (24 hr post day 1), 3, 8, 15, 16 (24 hr post day 15), 17, 22; Cycle 2: days 1, 2 (24 hr post day 1), 3, 8, 15
ID
Title
Description
OG000
FLT3 Mutated and Wild Type PKC412 Dose Escalation Combined
Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
Units
Counts
Participants
OG000
Primary
Summary of CGP62221 Concentration (E2)
Blood samples were collected for analysis.
The PK analysis set of the FLT3 mutated PKC412 dose escalation and FLT3 wild type PKC412 dose escalation combined arms, which consisted of the 14 newly enrolled participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.
Posted
Median
Full Range
ng/ml
Cycle 1: days 1, 2 (24 hr post day 1), 3, 8, 15, 16 (24 hr post day 15), 17, 22; Cycle 2: days 1, 2 (24 hr post day 1), 3, 8, 15
ID
Title
Description
OG000
FLT3 Mutated and Wild Type PKC412 Dose Escalation Combined
Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
Units
Counts
Participants
OG000
Primary
Summary of CGP52421 Concentration (E2)
Blood samples were collected for analysis.
The PK analysis set of the FLT3 mutated PKC412 dose escalation and FLT3 wild type PKC412 dose escalation combined arms, which consisted of the 14 newly enrolled participants, was considered for the analysis. For each time point, participants of the PK analysis set with non-missing values were analyzed.
Posted
Median
Full Range
ng/ml
Cycle 1: days 1, 2 (24 hr post day 1), 3, 8, 15, 16 (24 hr post day 15), 17, 22; Cycle 2: days 1, 2 (24 hr post day 1), 3, 8, 15
ID
Title
Description
OG000
FLT3 Mutated and Wild Type PKC412 Dose Escalation Combined
Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
Units
Counts
Participants
OG000
Secondary
Time to Disease Progression (TTP) (Core)
TTP was defined as the time from first dose date to date of disease progression which is identified as study completion date for unsatisfactory treatment effect or date of death from any cause within the 28 day cutoff post treatment.
Core primary efficacy population: The core primary efficacy population included all participants who were randomized.
Posted
Median
95% Confidence Interval
days
from date of FPFV, 29-Jan-2002, to date of LPLV, 04-Sep-2003
ID
Title
Description
OG000
PKC412 in FLT3 Mutated Participants (Core)
Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Units
Counts
Participants
OG000
Secondary
Summary of Midostaurin Plasma Concentration (Core)
Blood samples were collected for analysis.
The Core PK analysis set, which consisted of 15 participants, was considered for the analysis. For each time point, only participants of the PK set who had non-missing values were analyzed.
Posted
Mean
Standard Deviation
ng/ml
Cycle 1: days 1 (24 hour), 3, 8; Cycle 2: day 1,
ID
Title
Description
OG000
PKC412 in FLT3 Mutated Participants (Core)
Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Units
Counts
Participants
OG000
Secondary
Summary of CGP62221 Plasma Concentration (Core)
Blood samples were collected for analysis.
The Core PK analysis set, which consisted of 15 participants, were considered for the analysis. For each time point, only participants of the PK set who had non-missing values were analyzed.
Posted
Mean
Standard Deviation
ng/ml
Cycle 1: days 1 (24 hour), 3, 8; Cycle 2: day 1,
ID
Title
Description
OG000
PKC412 in FLT3 Mutated Participants (Core)
Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Units
Counts
Participants
OG000
Secondary
Summary of CGP52421 Plasma Concentration (Core)
Blood samples were collected for analysis.
The Core PK analysis set, which consisted of 15 participants, were considered for the analysis. For each time point, only participants of the PK set who had non-missing values were analyzed.
Posted
Mean
Standard Deviation
ng/ml
Cycle 1: days 1 (24 hour), 3, 8; Cycle 2: day 1,
ID
Title
Description
OG000
PKC412 in FLT3 Mutated Participants (Core)
Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Units
Counts
Participants
OG000
Secondary
Time to Disease Progression (E1)
TTP was defined as the time from the first dose date to the date of disease progression (defined as the study completion date for unsatisfactory treatment effect, date of response assessment of progressive disease, or date of death from any cause). One participant from the wild type 200 mg group did not have any assessment on treatment and therefore was not taken into account for TTP.
Primary efficacy population: defined as all patients who received at least 1 dose of study medication, completed at least eight days of therapy within Cycle 1 unless discontinued due to progressive disease and/or death due to any cause, and who were not considered to be associated with a protocol violation that was exclusionary from the population.
Posted
Median
95% Confidence Interval
days
from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004
ID
Title
Description
OG000
FLT3 Mutated PKC412 100 mg/Day (E1)
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
OG001
FLT3 Mutated PKC412 200 mg/Day (E1)
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
OG002
Secondary
Overall Survival (OS) (E1)
OS was measured from the date of the first dose of treatment to the date of death from any cause or to the last date that the patient was known to be alive (a censored observation).
Primary efficacy population: defined as all patients who received at least 1 dose of study medication, completed at least eight days of therapy within Cycle 1 unless discontinued due to progressive disease and/or death due to any cause, and who were not considered to be associated with a protocol violation that was exclusionary from the population.
Posted
Median
95% Confidence Interval
days
from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004
ID
Title
Description
OG000
FLT3 Mutated PKC412 100 mg/Day (E1)
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
OG001
FLT3 Mutated PKC412 200 mg/Day (E1)
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
OG002
FLT3 Wild Type PKC412 100 mg/Day (E1)
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Secondary
Duration of Best Clinical Response (E1)
Duration of best clinical response was measured from the time that the measurement criteria were met for CR, PR, MR (with or without blast reduction) or BR until the first date that recurrent disease was documented (event) or until the date of last follow up.
Responders from the PEP; PEP defined as all patients who received at least 1 dose of study medication, completed at least 8 days of therapy within Cycle 1 unless discontinued due to progressive disease and/or death due to any cause, and who were not considered to be associated with a protocol violation that was exclusionary from the population.
Posted
Median
95% Confidence Interval
days
from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004
ID
Title
Description
OG000
FLT3 Mutated PKC412 100 mg/Day (E1)
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
OG001
FLT3 Mutated PKC412 200 mg/Day (E1)
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
OG002
FLT3 Wild Type PKC412 100 mg/Day (E1)
Secondary
Event-free Survival (E1)
Event-free survival was defined as the time from date of start of treatment to the date of death from any cause, treatment failure or relapse
Primary efficacy population: defined as all patients who received at least 1 dose of study medication, completed at least eight days of therapy within Cycle 1 unless discontinued due to progressive disease and/or death due to any cause, and who were not considered to be associated with a protocol violation that was exclusionary from the population.
Posted
Median
95% Confidence Interval
days
from date of FPFV, 27-Mar-2003, to date of LPLV, 06-Sep-2004
ID
Title
Description
OG000
FLT3 Mutated PKC412 100 mg/Day (E1)
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
OG001
FLT3 Mutated PKC412 200 mg/Day (E1)
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
OG002
FLT3 Wild Type PKC412 100 mg/Day (E1)
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Secondary
Summary of PKC412 Plasma Concentration for 50 mg Twice Daily (Bid) Arm (E1)
Blood samples were collected for analysis.
The PK population of the mutated PKC412 100 mg/day and wild type PKC412 100 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..
Posted
Mean
Standard Deviation
ng/ml
Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h)
ID
Title
Description
OG000
FLT3 Mutated and Wild Type PKC412 100 mg/Day Arms Combined
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Units
Counts
Participants
OG000
Secondary
Summary of CGP62221 Plasma Concentration for 50 mg Bid Arm (E1)
Blood samples were collected for analysis.
The PK population of the mutated PKC412 100 mg/day and wild type PKC412 100 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..
Posted
Mean
Standard Deviation
ng/ml
Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h)
ID
Title
Description
OG000
FLT3 Mutated and Wild Type PKC412 100 mg/Day Arms Combined
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Units
Counts
Participants
OG000
Secondary
Summary of CGP52421 Plasma Concentration for 50 mg Bid Arm (E1)
Blood samples were collected for analysis.
The PK population of the mutated PKC412 100 mg/day and wild type PKC412 100 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..
Posted
Mean
Standard Deviation
ng/ml
Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h)
ID
Title
Description
OG000
FLT3 Mutated and Wild Type PKC412 100 mg/Day Arms Combined
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Units
Counts
Participants
OG000
Secondary
Summary of PKC412 Plasma Concentration for 100 mg Bid Arm (E1)
Blood samples were collected for analysis.
The PK population of the mutated PKC412 200 mg/day and wild type PKC412 200 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..
Posted
Mean
Standard Deviation
ng/ml
Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h); cycle 5: day 1 (0h) and cycle 6: day 1 (0h)
ID
Title
Description
OG000
FLT3 Mutated and Wild Type PKC412 200 mg/Day
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Units
Counts
Participants
OG000
Secondary
Summary of CGP62221 Plasma Concentration for 100 mg Bid Arm (E1)
Blood samples were collected for analysis.
The PK population of the mutated PKC412 200 mg/day and wild type PKC412 200 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..
Posted
Mean
Standard Deviation
ng/ml
Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h); cycle 5: day 1 (0h) and cycle 6: day 1 (0h)
ID
Title
Description
OG000
FLT3 Mutated and Wild Type PKC412 200 mg/Day
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Units
Counts
Participants
OG000
Secondary
Summary of CGP52421 Plasma Concentration for 100 mg Bid Arm (E1)
Blood samples were collected for analysis.
The PK population of the mutated PKC412 200 mg/day and wild type PKC412 200 mg/day arms combined, which consisted of all participants who provided at least one evaluable PK sample and received at least one dose of study treatment, was considered for the analysis. For each time point, only participants with non-missing values were analyzed..
Posted
Mean
Standard Deviation
ng/ml
Cycle 1: days 1 (0h, 4h, 24 h), 3 (0h), 8 (0h); cycle 2: days 1 (0h); cycle 3: day 1 (0h); cycle 4: day 1 (0h); cycle 5: day 1 (0h) and cycle 6: day 1 (0h)
ID
Title
Description
OG000
FLT3 Mutated and Wild Type PKC412 200 mg/Day
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Units
Counts
Participants
OG000
Secondary
Best Clinical Response (E2)
Best clinical response was defined as CR, PR, MR, MR+BR, or BR . CR and PR was defined according to NCI definitions, and MR and BR was defined according to the guidelines for defining hematologic improvement in MDS.
The primary efficacy population, which included all participants, who received at least one dose of study drug and who completed at least 8 days of treatment in Cycle 1, unless they discontinued due to progressive disease and/or death due to any cause, and who did not experience any protocol violations, was analyzed..
Posted
Number
Participants
date of FPFV, 21-Aug-2003, to date of LPLV, 27-Mar-2008
ID
Title
Description
OG000
FLT3 Mutated PKC412 Dose Escalation (E2)
Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
OG001
FLT3 Mutated PKC+Itraconazole (E2)
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Secondary
Time to Disease Progression (E2)
TTP was defined as the time from the first dose date to the date of disease progression, which was defined as the study completion date for unsatisfactory treatment effect, the date of response assessment of progressive disease, or the date of death from any cause
The primary efficacy population, which included all participants, who received at least one dose of study drug and who completed at least 8 days of treatment in Cycle 1, unless they discontinued due to progressive disease and/or death due to any cause, and who did not experience any protocol violations, was analyzed..
Posted
Median
95% Confidence Interval
days
date of FPFV, 21-Aug-2003, to date of LPLV, 27-Mar-2008
ID
Title
Description
OG000
FLT3 Mutated PKC412 Dose Escalation (E2)
Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
OG001
FLT3 Mutated PKC+Itraconazole (E2)
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Secondary
Overall Survival (E2)
OS was measured from the date of the first dose of treatment to the date of death from any cause or the last date the patient was known to be alive (censored observation)
The primary efficacy population, which included all participants, who received at least one dose of study drug and who completed at least 8 days of treatment in Cycle 1, unless they discontinued due to progressive disease and/or death due to any cause, and who did not experience any protocol violations, was analyzed..
Posted
Median
95% Confidence Interval
days
date of FPFV, 21-Aug-2003, to date of LPLV, 27-Mar-2008
ID
Title
Description
OG000
FLT3 Mutated PKC412 Dose Escalation (E2)
Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
OG001
FLT3 Mutated PKC+Itraconazole (E2)
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
PKC412 Core
Participants received 75 mg PKC412 three time daily (tid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
12
20
20
20
EG001
FLT3 Mutated PKC412 100 mg/Day (E1)
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
16
18
17
18
EG002
FLT3 Mutated PKC412 200 mg/Day (E1)
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
14
17
16
17
EG003
FLT3 Wild Type PKC412 100 mg/Day (E1)
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
22
33
32
33
EG004
FLT3 Wild Type PKC412 200 mg/Day (E1)
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
19
27
27
27
EG005
FLT3 Mutated PKC412 Dose Escalation (E2)
Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
7
9
9
9
EG006
FLT3 Mutated PKC+Itraconazole (E2)
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
6
7
6
7
EG007
FLT3 Wild Type PKC412 Dose Escalation (E2)
Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
5
7
7
7
EG008
FLT3 Wild Type PKC+Itraconazole (E2)
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
3
6
6
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG0033 affected33 at risk
EG0043 affected27 at risk
EG0050 affected9 at risk
EG0060 affected7 at risk
EG0071 affected7 at risk
EG0080 affected6 at risk
Anaemia NOS
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Anaemia haemolytic autoimmune
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0003 affected20 at risk
EG0013 affected18 at risk
EG0023 affected17 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0011 affected18 at risk
EG0021 affected17 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Splenic infarction
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Aortic valve incompetence
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Atrioventricular block
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Cardiac aneurysm
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Cardiomegaly
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Cardiopulmonary failure
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Aplasia
Congenital, familial and genetic disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Blindness
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Erythema of eyelid
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Abdominal pain NOS
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Gastric polyps
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Intestinal prolapse
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Pneumatosis intestinalis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Polyp colorectal
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0022 affected17 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Asthenia
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Chest discomfort
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Chest pain
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Chills
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Disease progression
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0012 affected18 at risk
EG0021 affected17 at risk
EG003
Drug interaction
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Fatigue
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
General physical health deterioration
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0021 affected17 at risk
EG003
Injection site cellulitis
General disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Lethargy
General disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Mucosal inflammation
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0021 affected17 at risk
EG003
Multi-organ failure
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Performance status decreased
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Pyrexia
General disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0011 affected18 at risk
EG0021 affected17 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Gallbladder disorder
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Hepatocellular damage
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Arthritis infective
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Aspergillosis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Bacterial sepsis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Bronchopneumonia NOS
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Candida sepsis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Candidiasis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Catheter bacteraemia
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Cellulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Central line infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Enterococcal bacteraemia
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Enterococcal sepsis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Erysipelas
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Gangrene
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Lobar pneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Mastoiditis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Mycobacterium avium complex infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Neutropenic infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Perianal abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0015 affected18 at risk
EG0021 affected17 at risk
EG003
Pneumonia NOS
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Pneumonia klebsiella
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Pseudomonal sepsis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Respiratory tract infection NOS
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Sepsis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Sepsis NOS
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Septic shock
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Sinusitis NOS
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Skin infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Soft tissue infection NOS
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Thrombophlebitis septic
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Subdural haemorrhage
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0022 affected17 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0022 affected17 at risk
EG003
Bacteria stool identified
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Blast cell count increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Blood amylase increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Blood creatinine increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Blood pressure increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
C-reactive protein increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Culture urine positive
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Fibrinolysis increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Gram stain positive
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Lipase increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Platelet count increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Transaminases increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Troponin NOS
Investigations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Urine output decreased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
White blood cell count decreased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
White blood cell count increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Diabetes mellitus non-insulin-dependent
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Bone infarction
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Chondrocalcinosis pyrophosphate
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Coccydynia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Blast cell crisis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Leukaemia recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Leukaemic infiltration pulmonary
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Leukostasis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Tumour lysis syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Aphasia
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Asterixis
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Coma
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Facial palsy
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Metabolic encephalopathy NOS
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Nervous system disorder
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Neurological symptom
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Somnolence
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Syncope
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Tonic clonic movements
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Delirium
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Bartholin's cyst
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0012 affected18 at risk
EG0022 affected17 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0004 affected20 at risk
EG0010 affected18 at risk
EG0022 affected17 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Maxillary sinusitis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Pulmonary alveolar haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Pulmonary oedema NOS
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Respiratory arrest
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0011 affected18 at risk
EG0021 affected17 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Septal panniculitis
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Urticaria NOS
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hypotension
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0012 affected18 at risk
EG0020 affected17 at risk
EG003
Hypotension NOS
Vascular disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Venous stasis
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0013 affected18 at risk
EG0021 affected17 at risk
EG0037 affected33 at risk
EG0043 affected27 at risk
EG0053 affected9 at risk
EG0060 affected7 at risk
EG0074 affected7 at risk
EG0084 affected6 at risk
Anaemia NOS
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0004 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0012 affected18 at risk
EG0021 affected17 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0011 affected18 at risk
EG0021 affected17 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0003 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0015 affected18 at risk
EG0020 affected17 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Splenomegaly
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Thrombocythaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0015 affected18 at risk
EG0021 affected17 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Bradycardia NOS
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Cardiovascular disorder
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0012 affected18 at risk
EG0022 affected17 at risk
EG003
Tachycardia NOS
Cardiac disorders
MedDRA
Systematic Assessment
EG0003 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Deafness neurosensory
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Mastoid disorder
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hyperaldosteronism
Endocrine disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Eye swelling
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0012 affected18 at risk
EG0020 affected17 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0014 affected18 at risk
EG0022 affected17 at risk
EG003
Abdominal pain NOS
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0003 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0012 affected18 at risk
EG0020 affected17 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0003 affected20 at risk
EG0011 affected18 at risk
EG0025 affected17 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0015 affected18 at risk
EG0028 affected17 at risk
EG003
Diarrhoea NOS
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0006 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0003 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Gastric dilatation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Gastric ileus
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0011 affected18 at risk
EG0021 affected17 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0005 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0022 affected17 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Lip ulceration
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Loose stools
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG00014 affected20 at risk
EG00111 affected18 at risk
EG0029 affected17 at risk
EG003
Neutropenic colitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Oral discomfort
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Oral mucosal petechiae
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Perianal erythema
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Rectal tenesmus
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Saliva altered
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Tongue blistering
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Tongue oedema
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG00112 affected18 at risk
EG0029 affected17 at risk
EG003
Vomiting NOS
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG00012 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Asthenia
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0015 affected18 at risk
EG0023 affected17 at risk
EG003
Catheter site erythema
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Catheter site pain
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Chest pain
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0022 affected17 at risk
EG003
Chills
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0012 affected18 at risk
EG0021 affected17 at risk
EG003
Fatigue
General disorders
MedDRA
Systematic Assessment
EG0008 affected20 at risk
EG0017 affected18 at risk
EG0026 affected17 at risk
EG003
Feeling cold
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
General physical health deterioration
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Generalised oedema
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Inflammation
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Injection site erythema
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Mucosal inflammation
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0013 affected18 at risk
EG0021 affected17 at risk
EG003
Nodule
General disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Oedema
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Oedema NOS
General disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Oedema peripheral
General disorders
MedDRA
Systematic Assessment
EG0008 affected20 at risk
EG0013 affected18 at risk
EG0024 affected17 at risk
EG003
Pain
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0012 affected18 at risk
EG0021 affected17 at risk
EG003
Pain NOS
General disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Pyrexia
General disorders
MedDRA
Systematic Assessment
EG0007 affected20 at risk
EG0017 affected18 at risk
EG0025 affected17 at risk
EG003
Rigors
General disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Submandibular mass
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Ulcer
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Vessel puncture site pain
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Hepatic function abnormal NOS
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0021 affected17 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0010 affected18 at risk
EG0022 affected17 at risk
EG003
Graft versus host disease
Immune system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Ano-rectal infection bacterial NOS
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Aspergillosis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Candidal infection NOS
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Candidiasis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Carbuncle
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Catheter site infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Cellulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Cystitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Ear infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Enterococcal infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Folliculitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0012 affected18 at risk
EG0020 affected17 at risk
EG003
Furuncle
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Herpes viral infection NOS
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Influenza
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Lung infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0021 affected17 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Oral herpes
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0012 affected18 at risk
EG0023 affected17 at risk
EG003
Puncture site infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Rash pustular
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Rhinitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Sepsis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0021 affected17 at risk
EG003
Sinusitis bacterial
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Skin infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Upper respiratory tract infection NOS
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Vaginal candidiasis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Viral infection NOS
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Blister
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Blood blister
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Contrast media reaction
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0021 affected17 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0023 affected17 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Limb injury NOS
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Post procedural pain
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Postoperative haematoma
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Subcutaneous haematoma
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0003 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0012 affected18 at risk
EG0024 affected17 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0013 affected18 at risk
EG0024 affected17 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0011 affected18 at risk
EG0022 affected17 at risk
EG003
Blood amylase increased
Investigations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA
Systematic Assessment
EG0003 affected20 at risk
EG0013 affected18 at risk
EG0021 affected17 at risk
EG003
Blood creatinine increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Blood glucose increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Blood in stool
Investigations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Body temperature increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Cardiac murmur NOS
Investigations
MedDRA
Systematic Assessment
EG0003 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Lipase increased
Investigations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Oxygen saturation decreased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Spleen palpable
Investigations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Weight decreased
Investigations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
White blood cell count increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Acidosis
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Alkalosis
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0005 affected20 at risk
EG0013 affected18 at risk
EG0022 affected17 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0012 affected18 at risk
EG0021 affected17 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0012 affected18 at risk
EG0023 affected17 at risk
EG003
Hyperglycaemia NOS
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0012 affected18 at risk
EG0023 affected17 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0013 affected18 at risk
EG0022 affected17 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0005 affected20 at risk
EG0017 affected18 at risk
EG0026 affected17 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0003 affected20 at risk
EG0012 affected18 at risk
EG0022 affected17 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0014 affected18 at risk
EG0023 affected17 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0011 affected18 at risk
EG0023 affected17 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0003 affected20 at risk
EG0012 affected18 at risk
EG0021 affected17 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0011 affected18 at risk
EG0022 affected17 at risk
EG003
Buttock pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Intervertebral disc disorder
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Muscle cramp
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0012 affected18 at risk
EG0020 affected17 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0022 affected17 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Nodule on extremity
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0011 affected18 at risk
EG0021 affected17 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Tendon disorder
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Benign lung neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Central nervous system leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Leukaemia cutis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Amnesia
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Ataxia
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Brain mass
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0012 affected18 at risk
EG0021 affected17 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0007 affected20 at risk
EG0015 affected18 at risk
EG0022 affected17 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hypogeusia
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Lethargy
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Neurological symptom
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Peroneal nerve palsy
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Postictal state
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Sleep apnoea syndrome
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Somnolence
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Tremor
Nervous system disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Agitation
Psychiatric disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA
Systematic Assessment
EG0004 affected20 at risk
EG0013 affected18 at risk
EG0021 affected17 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Depression
Psychiatric disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Hallucination NOS
Psychiatric disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0011 affected18 at risk
EG0022 affected17 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Bladder pain
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0021 affected17 at risk
EG003
Urge incontinence
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Breath sounds decreased
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0007 affected20 at risk
EG0014 affected18 at risk
EG0024 affected17 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0003 affected20 at risk
EG0015 affected18 at risk
EG0022 affected17 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0012 affected18 at risk
EG0020 affected17 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Hoarseness
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Increased upper airway secretion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Lung infiltration NOS
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0023 affected17 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Postnasal drip
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Pulmonary oedema NOS
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Rhonchi
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0021 affected17 at risk
EG003
Tonsillar ulcer
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Blood blister
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0012 affected18 at risk
EG0020 affected17 at risk
EG003
Contusion
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0003 affected20 at risk
EG0012 affected18 at risk
EG0021 affected17 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0003 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0011 affected18 at risk
EG0021 affected17 at risk
EG003
Penile ulceration
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0014 affected18 at risk
EG0021 affected17 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Purpura NOS
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0021 affected17 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0021 affected17 at risk
EG003
Skin lesion NOS
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Subcutaneous nodule
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Urticaria NOS
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Sinus operation
Surgical and medical procedures
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Haematoma
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Haematoma NOS
Vascular disorders
MedDRA
Systematic Assessment
EG0003 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hot flush
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Hypotension
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0012 affected18 at risk
EG0023 affected17 at risk
EG003
Hypotension NOS
Vascular disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Jugular vein thrombosis
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0021 affected17 at risk
EG003
Pallor
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Petechiae
Vascular disorders
MedDRA
Systematic Assessment
EG0003 affected20 at risk
EG0010 affected18 at risk
EG0020 affected17 at risk
EG003
Phlebitis
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected18 at risk
EG0022 affected17 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0021 affected17 at risk
EG003
Wound haemorrhage
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected18 at risk
EG0020 affected17 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis
862-778-8300
ID
Term
D015470
Leukemia, Myeloid, Acute
D009190
Myelodysplastic Syndromes
Ancestor Terms
ID
Term
D007951
Leukemia, Myeloid
D007938
Leukemia
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D006402
Hematologic Diseases
D006425
Hemic and Lymphatic Diseases
D001855
Bone Marrow Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D017964
Itraconazole
C059539
midostaurin
Ancestor Terms
ID
Term
D014230
Triazoles
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D010879
Piperazines
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
25 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
27 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
5 subjects
FG0042 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Condition no longer requires study drug
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Lack of Efficacy
FG0000 subjects
FG00111 subjects
FG00211 subjects
FG00323 subjects
FG00417 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Abnormal laboratory value
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0033 subjects
FG0046 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Death
FG0000 subjects
FG0014 subjects
FG0021 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Enrolled into PKC412A2104E2
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0059 subjects
FG0067 subjects
FG0077 subjects
FG0086 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0059 subjects
FG0067 subjects
FG0077 subjects
FG0086 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0073 subjects
FG0080 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0053 subjects
FG0062 subjects
FG0072 subjects
FG0086 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0054 subjects
FG0063 subjects
FG0071 subjects
FG0080 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Between 18 and 65 years
BG00011
BG00111
BG0028
BG0037
BG0048
BG0056
BG0065
BG0070
BG0080
BG00956
>=65 years
BG0009
BG0017
BG0029
BG00326
BG00419
BG0052
BG0062
BG0076
BG0086
BG00986
9
BG00317
BG00415
BG0053
BG0063
BG0074
BG0084
BG00966
Male
BG00014
BG00113
BG0028
BG00316
BG00412
BG0055
BG0064
BG0072
BG0082
BG00976
0
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
OG003
FLT3 Wild Type PKC412 200 mg/Day (E1)
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Units
Counts
Participants
OG00018
OG00117
OG00232
OG00325
Title
Denominators
Categories
Complete response
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Partial response
Title
Measurements
OG0000
OG0011
OG0020
OG003
Minor response
Title
Measurements
OG0001
OG0010
OG0026
OG003
Blast response
Title
Measurements
OG00011
OG00112
OG00215
OG003
Overall response
Title
Measurements
OG00012
OG00113
OG00221
OG003
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG003
FLT3 Wild Type PKC+Itraconazole (E2)
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
10
Title
Denominators
Categories
Cycle 1, day 21 (n=9)
Title
Measurements
OG00022261.53± 11984.6
Cycle 1, day 22 (n=10)
Title
Measurements
OG00037578.85± 44330.7
Cycle 1, day 28 (n=7)
Title
Measurements
OG00035630.45± 23993.2
10
Title
Denominators
Categories
Cycle 1 , day 21 (n=10)
Title
Measurements
OG0003945.00± 4440.238
Cycle 1, day 22 (n=10)
Title
Measurements
OG0003968.70± 4047.498
Cycle 1, day 28 (n=8)
Title
Measurements
OG0003931.25± 2638.135
10
Title
Denominators
Categories
Cycle 1, day 21 (n=10)
Title
Measurements
OG0001.6(1.0 to 8.1)
Cycle 1, day 22 (n=10)
Title
Measurements
OG0001.9(1.2 to 4.7)
Cycle 1, day 28 (n=8)
Title
Measurements
OG0002.2(0.0 to 3.3)
10
Title
Denominators
Categories
Cycle 1, day 21 (n=10)
Title
Measurements
OG00032120.58± 35792.2
Cycle 1, day 22 (n=10)
Title
Measurements
OG00034684.6± 37084.9
Cycle 1, day 28, (n=8)
Title
Measurements
OG00033020.17± 17206.3
8
Title
Denominators
Categories
Cycle 1, day 21 (n=6)
Title
Measurements
OG00018.13± 13.505
Cycle 1, day 22 (n=8)
Title
Measurements
OG00013.23± 6.346
8
Title
Denominators
Categories
Cycle 1, day 21 (n=8)
Title
Measurements
OG00030217.82± 16502.90
Cycle 1, day 22 (n=7)
Title
Measurements
OG00023824.69± 13300.69
Cycle 1, day 28 (n=7)
Title
Measurements
OG00031545.54± 12453.16
10
Title
Denominators
Categories
Cycle 1, day 21 (n=10)
Title
Measurements
OG0003259.30± 1747.923
Cycle 1, day 22 (n=10)
Title
Measurements
OG0003221.40± 1980.217
Cycle 1, day 28 (n=8)
Title
Measurements
OG0003032.25± 1975.371
10
Title
Denominators
Categories
Cycle 1, day 21 (n=10)
Title
Measurements
OG0003.7(0.0 to 10.3)
Cycle 1, day 22 (n=10)
Title
Measurements
OG0002.3(0.0 to 6.1)
Cycle 1, day 28 (n=8)
Title
Measurements
OG0003.3(0.0 to 8.5)
10
Title
Denominators
Categories
Cycle 1, day 21 (n=10)
Title
Measurements
OG00031699.93± 15573.87
Cycle 1, day 22 (n=10)
Title
Measurements
OG00031182.90± 17380.39
Cycle 1, day 28 (n=8)
Title
Measurements
OG00026688.60± 10901.40
4
Title
Denominators
Categories
Title
Measurements
OG00014.37± 6.743
9
Title
Denominators
Categories
Cycle 1, day 21 (n=9)
Title
Measurements
OG00040258.65± 9747.374
Cycle 1, day 22 (n=7)
Title
Measurements
OG00042950.76± 8604.972
Cycle 1, day 28 (n=7)
Title
Measurements
OG00049758.77± 7733.621
10
Title
Denominators
Categories
Cycle 1, day 21 (n=10)
Title
Measurements
OG0004173.00± 985.473
Cycle 1, day 22 (n=10)
Title
Measurements
OG0004293.00± 1292.380
Cycle 1, day 28 (n=8)
Title
Measurements
OG0004875.00± 1376.382
10
Title
Denominators
Categories
Cycle 1, day 21 (n=10)
Title
Measurements
OG0003.5(0.0 to 6.5)
Cycle 1, day 22 (n=10)
Title
Measurements
OG0002.1(0.0 to 10.7)
Cycle 1, day 28 (n=8)
Title
Measurements
OG0002.2(0.0 to 8.3)
10
Title
Denominators
Categories
Cycle 1, day 21 (n=10)
Title
Measurements
OG00038899.84± 7616.481
Cycle 1, day 22 (n=10)
Title
Measurements
OG00041035.50± 10807.22
Cycle 1, day 28 (n=8)
Title
Measurements
OG00044447.05± 8906.006
12
Title
Denominators
Categories
Cycle 1, day 1 (=7)
Title
Measurements
OG0000(0 to 0)
Cycle 1, day 2 (24 hours post day 1) (n=12)
Title
Measurements
OG0002565.0(1170.0 to 7250.0)
Cycle 1, day 3 (n=12)
Title
Measurements
OG0003100.0(1340.0 to 9080.0)
Cycle 1, day 8 (n=8)
Title
Measurements
OG0001640.0(1030.0 to 4340.0)
Cycle 1, day 15 (n=6)
Title
Measurements
OG000744.5(549.0 to 7080.0)
Cycle 1, day 16 (24 hr post day 15) (n=6)
Title
Measurements
OG000836.0(669.0 to 9120.0)
Cycle 1, day 17 (n=5)
Title
Measurements
OG000800.0(710.0 to 982.0)
Cycle 1, day 22 (n=5)
Title
Measurements
OG0001410.0(595.0 to 6270.0)
Cycle 2, day 1 (n=4)
Title
Measurements
OG000772.0(667.0 to 2670.0)
Cycle 2, day 2 (24 hr post day 1) (n=4)
Title
Measurements
OG0001141.0(516.0 to 6410.0)
Cycle 2, day3 (n=4)
Title
Measurements
OG0001295.0(610.0 to 7450.0)
Cycle 2, day 8 (n=4)
Title
Measurements
OG0001210.0(727.0 to 1420.0)
Cycle 2, day 15 (n=3)
Title
Measurements
OG000834.0(515.0 to 1000.0)
12
Title
Denominators
Categories
Cycle 1, day 1 (n=7)
Title
Measurements
OG0000(0 to 0)
Cycle 1, day 2 (24 hr post day 1) (n=12)
Title
Measurements
OG0001320.0(570.0 to 2720.0)
Cycle 1, day 3 (n=12)
Title
Measurements
OG0002750.0(1800.0 to 4340.0)
Cycle 1, day 8 (n=8)
Title
Measurements
OG0002380.0(2000.0 to 7380.0)
Cycle 1, day 15 (n=6)
Title
Measurements
OG0001505.0(1110.0 to 4630.0)
Cycle 1, day 16 (24 hr post day 15) (n=6)
Title
Measurements
OG0001425.0(1190.0 to 5390.0)
Cycle 1, day 17 (n=5)
Title
Measurements
OG0001480.0(1200.0 to 1710.0)
Cycle 1, day 22 (n=5)
Title
Measurements
OG0001520.0(1410.0 to 3330.0)
Cycle 2, day 1 (n=4)
Title
Measurements
OG0001545.0(1350.0 to 3210.0)
Cycle 2, day 2 (24 hr post day 1) (n=4)
Title
Measurements
OG0001945.0(880.0 to 3430.0)
Cycle 2, day 3 (n=4)
Title
Measurements
OG0002070.0(1260.0 to 3430.0)
Cycle 2, day 8 (n=4)
Title
Measurements
OG0002030.0(1620.0 to 2360.0)
Cycle 2, day 15 (n=3)
Title
Measurements
OG0001740.0(1360.0 to 1790.0)
12
Title
Denominators
Categories
Cycle 1, day 1 (n=7)
Title
Measurements
OG0000(0 to 0)
Cycle 1, day 2 (24 hr post day 1) (n=12)
Title
Measurements
OG000684.0(0.0 to 1100.0)
Cycle 1, day 3 (n=12)
Title
Measurements
OG0001185.0(1020.0 to 1860.0)
Cycle 1, day 8 (n=8)
Title
Measurements
OG0002835.0(2230.0 to 3950.0)
Cycle 1, day 15 (n=6)
Title
Measurements
OG0003845.0(1810.0 to 6110.0)
Cycle 1, day 16 (24 hr post day 15) (n=6)
Title
Measurements
OG0003830.0(1830.0 to 6070.0)
Cycle 1, day 17 (n=5)
Title
Measurements
OG0003620.0(2120.0 to 4560.0)
Cycle 1, day 22 (n=5)
Title
Measurements
OG0004470.0(1860.0 to 8500.0)
Cycle 2, day 1 (n=4)
Title
Measurements
OG0004915.0(379.0 to 6590.0)
Cycle 2, day 2 (24 hr post day 1) (n=4)
Title
Measurements
OG0004455.0(185.0 to 9610.0)
Cycle 2, day 3 (n=4)
Title
Measurements
OG0004470.0(3150.0 to 5210.0)
Cycle 2, day 8 (n=4)
Title
Measurements
OG0004860.0(3500.0 to 5570.0)
Cycle 2, day 15 (n=3)
Title
Measurements
OG0004030.0(3370.0 to 5780.0)
20
Title
Denominators
Categories
Title
Measurements
OG00063.0(26.0 to 92.0)
10
Title
Denominators
Categories
Cycle 1, day 1(24 hour) (n=10)
Title
Measurements
OG0003801.0± 2529.069
Cycle 1, day 3 (n=7)
Title
Measurements
OG0007152.86± 4254.173
Cycle 1, day 8 (n=9)
Title
Measurements
OG0005154.44± 5004.511
Cycle 2, day 1 (n=6)
Title
Measurements
OG0001873.17± 1521.685
10
Title
Denominators
Categories
Cycle 1, day 1 (24 hour) (n=10)
Title
Measurements
OG0001636.00± 612.938
Cycle 1, day 3 (n=7)
Title
Measurements
OG0003143.71± 1147.407
Cycle 1, day 8 (n=9)
Title
Measurements
OG0004873.33± 3421.593
Cycle 2, day 1 (n=6)
Title
Measurements
OG0002816.67± 2095.850
10
Title
Denominators
Categories
Cycle 1, day 1 (24 hour) (n=10)
Title
Measurements
OG000951.70± 297.866
Cycle 1, day 3 (n=7)
Title
Measurements
OG0001846.57± 657.472
Cycle 1, day 8 (n=9)
Title
Measurements
OG0006342.22± 2586.440
Cycle 2, day 1 (n=6)
Title
Measurements
OG00012978.33± 4036.436
FLT3 Wild Type PKC412 100 mg/Day (E1)
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
OG003
FLT3 Wild Type PKC412 200 mg/Day (E1)
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Units
Counts
Participants
OG00018
OG00117
OG00232
OG00325
Title
Denominators
Categories
Title
Measurements
OG00077.0(36.0 to 109.0)
OG00150.0(24.0 to 63.0)
OG00262.0(30.0 to 82.0)
OG00354.0(29.0 to 84.0)
OG003
FLT3 Wild Type PKC412 200 mg/Day (E1)
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Units
Counts
Participants
OG00018
OG00117
OG00232
OG00325
Title
Denominators
Categories
Title
Measurements
OG00099.0(61.0 to 120.0)
OG00193.0(52.0 to 139.0)
OG002145.0(75.0 to 257.0)
OG003159.0(98.0 to 313.0)
Participants received 50 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
OG003
FLT3 Wild Type PKC412 200 mg/Day (E1)
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Units
Counts
Participants
OG00012
OG00113
OG00221
OG00311
Title
Denominators
Categories
Title
Measurements
OG00057.0(8.0 to 86.0)
OG00129.0(4.0 to 35.0)
OG00256.0(29.0 to 78.0)
OG00358.0(9.0 to 192.0)
OG003
FLT3 Wild Type PKC412 200 mg/Day (E1)
Participants received 100 mg PKC412 twice daily (bid) orally on a continuous basis until disease progression or the occurrence of unacceptable treatment related toxicity.
Units
Counts
Participants
OG00018
OG00117
OG00232
OG00325
Title
Denominators
Categories
Title
Measurements
OG00060.0(1.0 to 109.0)
OG00150.0(1.0 to 63.0)
OG00258.0(1.0 to 82.0)
OG0031.0(1.0 to 42.0)
43
Title
Denominators
Categories
Cycle 1, day 1 (0h) (n=43)
Title
Measurements
OG0000.000± 0.0000
Cycle 1, day 1 (4h) (n=38)
Title
Measurements
OG0001198.000± 522.4766
Cycle 1, day 1 (24h) (n=39)
Title
Measurements
OG0001735.974± 1161.933
Cycle 1, day 3 (0h) (n=34)
Title
Measurements
OG0002585.471± 1843.852
Cycle 1, day 8 (0h) (n=30)
Title
Measurements
OG0003576.467± 3263.112
Cycle 2, day 1 (0h) (n=22)
Title
Measurements
OG0001756.500± 1695.327
Cycle 3, day 1 (0h) (n=12)
Title
Measurements
OG0002038.417± 2079.252
Cycle 4, day 1 (0h) (n=4)
Title
Measurements
OG000820.750± 565.0247
44
Title
Denominators
Categories
Cycle 1, day 1 (0h) (n=44)
Title
Measurements
OG0000.000± 0.0000
Cycle 1, day 1 (4h) (n=38)
Title
Measurements
OG000367.079± 220.2728
Cycle 1, day 1 (24h) (n=39)
Title
Measurements
OG000808.182± 375.4818
Cycle 1, day 3 (0h) (n=34)
Title
Measurements
OG0001400.476± 681.9106
Cycle 1, day 8 (0h) (n=30)
Title
Measurements
OG0002868.933± 1723.985
Cycle 2, day 1 (0h) (n=22)
Title
Measurements
OG0001930.000± 1241.980
Cycle 3, day 1 (0h) (n=12)
Title
Measurements
OG0001971.500± 1519.628
Cycle 4, day 1 (0h) (n=4)
Title
Measurements
OG0001207.500± 310.5238
41
Title
Denominators
Categories
Cycle 1, day 1 (0h) (n=41)
Title
Measurements
OG0000.000± 0.0000
Cycle 1, day 1 (4h) (n=38)
Title
Measurements
OG000203.013± 121.3817
Cycle 1, day 1 (24h) (n=39)
Title
Measurements
OG000436.282± 210.1306
Day 1, day 3 (0h) (n=34)
Title
Measurements
OG0001188.359± 1833.644
Cycle 1, day 8 (0h) (n=30)
Title
Measurements
OG0002840.833± 1158.132
Cycle 2, day 1 (0h) (n=22)
Title
Measurements
OG0006467.591± 3434.776
Cycle 3, day 1 (0h) (n=12)
Title
Measurements
OG0008175.000± 4851.968
Cycle 4, day 1 (0h) (n=4)
Title
Measurements
OG0006205.000± 1619.084
38
Title
Denominators
Categories
Cycle 1, day 1 (0h) (n=38)
Title
Measurements
OG0000.000± 0.0000
Cycle 1, day 1 (4h) (n=34)
Title
Measurements
OG0002087.088± 1087.277
Cycle 1, day 1 (24h) (n=36)
Title
Measurements
OG0002849.731± 2150.176
Cycle 1, day 3 (0h) (n=29)
Title
Measurements
OG0003756.483± 2549.759
Cycle 1, day 8 (0h) (n=24)
Title
Measurements
OG0004447.583± 4233.285
Cycle 2, day 1 (0h) (n=15)
Title
Measurements
OG0001226.333± 894.1562
Cycle 3, day 2 (0h) (n=6)
Title
Measurements
OG000754.500± 264.6860
Cycle 4, day 1 (0h) (n=6)
Title
Measurements
OG0001187.167± 1026.004
Cycle 5, day 1 (0h) (n=4)
Title
Measurements
OG000572.250± 314.7405
Cycle 6, day 1 (0h) (n=4)
Title
Measurements
OG0001433.250± 1670.029
39
Title
Denominators
Categories
Cycle 1, day 1 (0h) (n=39)
Title
Measurements
OG0000.000± 0.0000
Cycle 1, day 1 (4h) (n=34)
Title
Measurements
OG000471.635± 342.7850
Cycle 1, day 1 (24h) (n=36)
Title
Measurements
OG0001134.764± 655.1779
Cycle 1, day 3 (0h) (n=29)
Title
Measurements
OG0001944.069± 1049.770
Cycle 1, day 8 (0h) (n=24)
Title
Measurements
OG0002898.708± 1876.446
Cycle 2, day 1 (0h) (n=15)
Title
Measurements
OG0001828.667± 650.1524
Cycle 3, day 2 (0h) (n=6)
Title
Measurements
OG0001258.333± 289.0271
Cycle 4, day 1 (0h) (n=6)
Title
Measurements
OG0001602.950± 1071.167
Cycle 5, day 1 (0h) (n4)
Title
Measurements
OG0001111.250± 357.8728
Cycle 6, day 1 (0h) (n=4)
Title
Measurements
OG0001662.500± 864.4603
38
Title
Denominators
Categories
Cycle 1, day 1 (0h) (n=38)
Title
Measurements
OG0000.000± 0.0000
Cycle 1, day 1 (4h) (n=34)
Title
Measurements
OG000257.391± 148.6420
Cycle 1, day 1 (24h) (n=36)
Title
Measurements
OG000666.194± 313.5770
Cycle 1, day 3 (0h) (n=29)
Title
Measurements
OG0001394.062± 653.2943
Cycle 1, day 8 (0h) (n=24)
Title
Measurements
OG0004447.500± 1359.192
Cycle 2, day 1 (0h) (n=15)
Title
Measurements
OG0009196.667± 3248.590
Cycle 3, day 2 (0h) (n=6)
Title
Measurements
OG0008811.667± 3376.172
Cycle 4, day 1 (0h) (n=6)
Title
Measurements
OG0006266.667± 3895.452
Cycle 5, day 1 (0h) (n4)
Title
Measurements
OG0007845.000± 4078.313
Cycle 6, day 1 (0h) (n=4)
Title
Measurements
OG0008710.000± 4890.774
OG002
FLT3 Wild Type PKC412 Dose Escalation (E2)
Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
OG003
FLT3 Wild Type PKC+Itraconazole (E2)
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Units
Counts
Participants
OG0009
OG0017
OG0027
OG0036
Title
Denominators
Categories
Complete response
Title
Measurements
OG0000
OG0010
OG0020
OG0031
Partial response
Title
Measurements
OG0000
OG0010
OG0020
OG003
Minor response
Title
Measurements
OG0000
OG0010
OG0020
OG003
Minor response and blast response
Title
Measurements
OG0001
OG0010
OG0022
OG003
Blast response
Title
Measurements
OG0004
OG0010
OG0020
OG003
Best clinical response
Title
Measurements
OG0005
OG0010
OG0022
OG003
OG002
FLT3 Wild Type PKC412 Dose Escalation (E2)
Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
OG003
FLT3 Wild Type PKC+Itraconazole (E2)
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Units
Counts
Participants
OG0009
OG0017
OG0027
OG0036
Title
Denominators
Categories
Title
Measurements
OG00049.0(11.0 to 222.0)
OG00126.0(12.0 to 50.0)
OG002169.0(113.0 to 370.0)
OG00378.0(29.0 to 1348.0)
OG002
FLT3 Wild Type PKC412 Dose Escalation (E2)
Participants were treated with PKC412 orally starting at a dose of 100 mg bid. A dose increase up to 300 mg bid was allowed. Participants were treated until time of disease progression, doubling of the bone marrow blast percentage from baseline, or the occurrence of unacceptable toxicity.
OG003
FLT3 Wild Type PKC+Itraconazole (E2)
Within a cycle of 28 days, participants received a loading dose of PKC412 100 mg bid on days 1-2, followed by PKC412 50 mg bid for 3 weeks from days 3-21. On day 22, itraconazole 100 mg bid was added to the treatment regimen. The combinations of PKC412 and Itraconazole continued until disease progression, unacceptable toxicity, or withdrawal of consent.
Units
Counts
Participants
OG0009
OG0017
OG0027
OG0036
Title
Denominators
Categories
Title
Measurements
OG000116.0(11.0 to 222.0)
OG00175.0(26.0 to 194.0)
OG002372.0(276.0 to NA)The upper 95% confidence interval could not be calculated.
OG003220.0(64.0 to NA)The upper 95% confidence interval could not be calculated.