Safety of KAE609 in Adults With Uncomplicated Plasmodium... | NCT03334747 | Trialant
NCT03334747
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Oct 11, 2021Actual
Enrollment
188Actual
Phase
Phase 2
Conditions
Malaria
Interventions
KAE609
Coartem
Countries
Gabon
Ghana
Mali
Rwanda
Uganda
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT03334747
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CKAE609A2202
Secondary IDs
ID
Type
Description
Link
207813/Z/17/Z
Other Grant/Funding Number
Wellcome Trust
Brief Title
Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.
Official Title
A Phase 2, Multi-center, Randomized, Open-label, Dose-escalation Study to Determine Safety of Single (QD) and Multiple (3 QD) Doses of KAE609, Given to Adults With Uncomplicated Plasmodium Falciparum Malaria.
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Oct 2021
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
Nov 16, 2017Actual
Primary Completion Date
Nov 23, 2019Actual
Completion Date
Nov 23, 2019Actual
First Submitted Date
Oct 27, 2017
First Submission Date that Met QC Criteria
Nov 2, 2017
First Posted Date
Nov 7, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Sep 3, 2020
Results First Submitted that Met QC Criteria
Sep 3, 2020
Results First Posted Date
Sep 25, 2020Actual
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
Oct 7, 2021
Last Update Posted Date
Oct 11, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Name
Class
Wellcome Trust
OTHER
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
No
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
KAE609 will be evaluated primarily for hepatic safety of single and multiple doses in sequential cohorts with increasing doses.This study aims to determine the maximum safe dose of the investigational drug KAE609 in malaria patients.
Detailed Description
Not provided
Conditions Module
Conditions
Malaria
Keywords
uncomplicated Plasmodium falciparum Malaria.
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
188Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Treatment arm 1: KAE609 10 mg Single Dose (SD)
Experimental
KAE609 10 mg once daily (QD) for 1 day
Drug: KAE609
Treatment arm 2:KAE609 25 mg SD
Experimental
KAE609 25 mg once daily (QD) for 1 day
Drug: KAE609
Treatment arm 3:KAE609 10 mg 3 Days
Experimental
KAE609 10 mg (QD) for 3 days
Drug: KAE609
Treatment arm 4:KAE609 50 mg SD
Experimental
KAE609 50 mg once daily (QD) for 1 day
Drug: KAE609
Treatment arm 5:KAE609 25 mg 3 Days
Experimental
KAE609 25 mg once daily (QD) for 3 days
Drug: KAE609
Treatment arm 6:KAE609 75 mg SD
Experimental
KAE609 75 mg once daily (QD) for 1 day
Interventions
Name
Type
Description
Arm Group Labels
Other Names
KAE609
Drug
Exploration of different doses of KAE609 to establish safety profile.
Treatment arm 1: KAE609 10 mg Single Dose (SD)
Treatment arm 2:KAE609 25 mg SD
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With at Least 2 CTCAE Grades Increase From Baseline in Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)
The occurrence of at least 2 CTCAE grades increase from baseline in ALT or AST during the 4 weeks study period was evaluated to characterize hepatic safety aspects of single and multiple ascending doses of KAE609 in adult malaria subjects for treatment of uncomplicated malaria caused by plasmodium falciparum. If 2 patients in a 10 patient cohort (Cohorts 1 and 2) or 3 patients in a 20 patient cohort (Cohorts 3, 4 and 5) had at least 2 CTCAE grades increase from Baseline in ALT or AST, recruitment was suspended and a review of liver safety (and any other relevant data) by safety review committee was initiated. Any further progression of the study was based on the decision by the safety review committee.
Day 29
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected and Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 15 and Day 29
PCR-corrected and PCR-uncorrected were evaluated at Days 15 and 29 (i.e., 14 and 28 days post-dose). The presence of parasitaemia after 7 days due to reinfection was considered as PCR-corrected ACPR. Missing blood smear data at Day 15 visit and thereafter were not considered as responder for the visit unless there was a later blood smear test indicating no parasitaemia.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
KEY Inclusion Criteria:
Male and female patients ≥ 18 years with a body weight ≥ 45 kg.
Microscopic confirmation of acute uncomplicated P. falciparum using by Giemsa-stained thick film.
P. falciparum parasitaemia of 500 to 50 000 parasites/µL.
Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours.
Written informed consent must be obtained before any study assessment is performed. If the patient is unable to write, then a witnessed consent according to local ethical standards is permitted.
KEY Exclusion Criteria:
Mixed Plasmodium infections.
Signs and symptoms of severe malaria according to World Health Organization (WHO) 2016 criteria (WHO 2016).
Known liver abnormalities, liver cirrhosis (compensated or decompensated), known active or history of hepatitis B or C (testing not required), known gallbladder or bile duct disease, acute or chronic pancreatitis.
Clinical or laboratory evidence of any of the following:
AST/ALT > 1.5 x the upper limit of normal range (ULN), regardless of the level of total bilirubin
AST/ALT > 1.0 and ≤ 1.5 x ULN and total bilirubin is > ULN
Total bilirubin > 2 x ULN, regardless of the level of AST/ALT
History of photodermatitis/increased sensitivity to sun.
Pregnant or nursing (lactating) women.
Known disturbances of electrolyte balance, e.g. hypokalemia, hypocalcemia or hypomagnesemia.
Moderate to severe anemia (Hemoglobin level <8 g/dL).
Other protocol-defined inclusion/exclusion criteria may apply
Ndayisaba G, Yeka A, Asante KP, Grobusch MP, Karita E, Mugerwa H, Asiimwe S, Oduro A, Fofana B, Doumbia S, Jain JP, Barsainya S, Kullak-Ublick GA, Su G, Schmitt EK, Csermak K, Gandhi P, Hughes D. Hepatic safety and tolerability of cipargamin (KAE609), in adult patients with Plasmodium falciparum malaria: a randomized, phase II, controlled, dose-escalation trial in sub-Saharan Africa. Malar J. 2021 Dec 20;20(1):478. doi: 10.1186/s12936-021-04009-1.
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
Approximately, 210 patients were planned to be randomized in six cohorts (KAE609: 150 and Coartem: 60). A total of 188 (KAE609: 137 and Coartem: 51) subjects were randomized in five cohorts. Cohort 6 was optional and never initiated. Two of the 188 randomized subjects were not treated and therefore were excluded from all analyses.
Recruitment Details
This study was conducted in 10 centers in 5 countries: Mali (2), Uganda (3), Ghana (2), Gabon (1), Rwanda (2).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
KAE609 10 mg SD
KAE609 10 mg once daily (QD) for 1 day
FG001
KAE609 10 mg QD 3 Days
KAE609 10 mg (QD) for 3 days
FG002
KAE609 25 mg SD
KAE609 25 mg once daily (QD) for 1 day
FG003
KAE609 25 mg QD 3 Days
KAE609 25 mg once daily (QD) for 3 days
FG004
KAE609 50 mg SD
KAE609 50 mg once daily (QD) for 1 day
FG005
KAE609 50 mg QD 3 Days
KAE609 50 mg once daily (QD) for 3 days
FG006
KAE609 75 mg SD
KAE609 75 mg once daily (QD) for 1 day
FG007
KAE609 150 mg SD
KAE609 150 mg once daily (QD) for 1 day
FG008
Pooled Coartem Control
control arm
Periods
Title
Milestones
Reasons Not Completed
Treatment Phase
Type
Comment
Milestone Data
STARTED
Randomized set (RAN)
FG00010 subjects
FG00110 subjects
FG00212 subjects
FG00320 subjects
FG004
COMPLETED
FG0009 subjects
FG00110 subjects
FG00212 subjects
FG00320 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Technical problems
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Follow-Up Phase
Type
Comment
Milestone Data
STARTED
FG0009 subjects
FG00110 subjects
FG00212 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Randomized set (RAN)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
KAE609 10 mg SD
KAE609 10 mg once daily (QD) for 1 day
BG001
KAE609 10 mg QD 3 Days
KAE609 10 mg (QD) for 3 days
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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 at Least 2 CTCAE Grades Increase From Baseline in Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)
The occurrence of at least 2 CTCAE grades increase from baseline in ALT or AST during the 4 weeks study period was evaluated to characterize hepatic safety aspects of single and multiple ascending doses of KAE609 in adult malaria subjects for treatment of uncomplicated malaria caused by plasmodium falciparum. If 2 patients in a 10 patient cohort (Cohorts 1 and 2) or 3 patients in a 20 patient cohort (Cohorts 3, 4 and 5) had at least 2 CTCAE grades increase from Baseline in ALT or AST, recruitment was suspended and a review of liver safety (and any other relevant data) by safety review committee was initiated. Any further progression of the study was based on the decision by the safety review committee.
Safety Set (SAF). Only participants with baseline and at least one post-baseline assessment for either ALT or AST are included in the analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 29
ID
Title
Description
Adverse Events Module
Frequency Threshold
5
Time Frame
All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 2 years.
Patients were randomized to KAE609 and Coartem in parallel treatment arms. Increasing doses of KAE609 (single dose and multiple dose) were evaluated in dose escalated manner in sequential cohorts
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: KAE609
Treatment arm 7:KAE609 50 mg 3 Days
Experimental
KAE609 50 mg once daily (QD) for 3 days
Drug: KAE609
Treatment arm 8: KAE609 150 mg SD
Experimental
KAE609 150 mg once daily (QD) for 1 day
Drug: KAE609
Treatment arm 9: Coartem Control
Active Comparator
Coartem® control
Drug: Coartem
Treatment arm 3:KAE609 10 mg 3 Days
Treatment arm 4:KAE609 50 mg SD
Treatment arm 5:KAE609 25 mg 3 Days
Treatment arm 6:KAE609 75 mg SD
Treatment arm 7:KAE609 50 mg 3 Days
Treatment arm 8: KAE609 150 mg SD
Cipargamin
Coartem
Drug
Control Arm
Treatment arm 9: Coartem Control
Artemether Lumefantrine
Day 15, Day 29
Parasite Clearance Time (PCT)
Parasite Clearance Time (PCT) is defined as the time from the first dose until the first total and continued disappearance of asexual parasite forms which remained at least a further 48 hours. In case a patient received rescue medication before (parasite) clearance, the time to event was censored at the first use of rescue medication.
Day 29
Fever Clearance Time (FCT)
Fever Clearance Time (FCT) is defined as the time from the first dose until the first time the axillary body temperature decreased below and remained below 37.5°C axillary or 38.0°C oral/tympanic/rectal for at least a further 24 hours. In case a patient received rescue medication before (fever) clearance, the time to event was censored at the first use of rescue medication.
Day 29
Time to Recrudescence and Reinfection at Study Day 29
Time to recrudescence is calculated from the date of first study medication to the date of first event. Participants without recrudescence/reinfection after Day 7 are censored at the time of treatment failure or at the time of last parasite assessment if no treatment failure occured.
Day 29
Maximum Peak Observed Concentration (Cmax)
Maximum Peak Observed Concentration (Cmax)
Day 1, Day 3
Tmax
Tmax
Day 1, Day 3
AUC0-24
AUC0-24
Day 1, Day 3
Half-life (T^1/2)
Half-life (T^1/2)
Upto day 15 post dose
Kintampo
Ghana
Novartis Investigative Site
Navrango
Ghana
Novartis Investigative Site
Bamako
Mali
Novartis Investigative Site
Sotouba
Mali
Novartis Investigative Site
Kigali
Rwanda
Novartis Investigative Site
Bushenyi
Uganda
Novartis Investigative Site
Kampala
Uganda
Novartis Investigative Site
Tororo
Uganda
Derived
Schmitt EK, Ndayisaba G, Yeka A, Asante KP, Grobusch MP, Karita E, Mugerwa H, Asiimwe S, Oduro A, Fofana B, Doumbia S, Su G, Csermak Renner K, Venishetty VK, Sayyed S, Straimer J, Demin I, Barsainya S, Boulton C, Gandhi P. Efficacy of Cipargamin (KAE609) in a Randomized, Phase II Dose-Escalation Study in Adults in Sub-Saharan Africa With Uncomplicated Plasmodium falciparum Malaria. Clin Infect Dis. 2022 May 30;74(10):1831-1839. doi: 10.1093/cid/ciab716.
22 subjects
FG00520 subjects
FG00621 subjects
FG00722 subjects
FG00851 subjects
21 subjects
FG00519 subjects
FG00621 subjects
FG00722 subjects
FG00851 subjects
1 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Subject/guardian decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
20 subjects
FG00421 subjects
FG00519 subjects
FG00621 subjects
FG00722 subjects
FG00851 subjects
COMPLETED
FG0009 subjects
FG00110 subjects
FG00212 subjects
FG00320 subjects
FG00421 subjects
FG00519 subjects
FG00620 subjects
FG00722 subjects
FG00850 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0081 subjects
Type
Comment
Reasons
Subject/guardian decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0081 subjects
BG002
KAE609 25 mg SD
KAE609 25 mg once daily (QD) for 1 day
BG003
KAE609 25 mg QD 3 Days
KAE609 25 mg once daily (QD) for 3 days
BG004
KAE609 50 mg SD
KAE609 50 mg once daily (QD) for 1 day
BG005
KAE609 50 mg QD 3 Days
KAE609 50 mg once daily (QD) for 3 days
BG006
KAE609 75 mg SD
KAE609 75 mg once daily (QD) for 1 day
BG007
KAE609 150 mg SD
KAE609 150 mg once daily (QD) for 1 day
BG008
Pooled Coartem Control
control arm
BG009
Total
Total of all reporting groups
10
BG00110
BG00212
BG00320
BG00422
BG00520
BG00621
BG00722
BG00851
BG009188
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00031.5± 10.48
BG00135.4± 13.25
BG00233.0± 14.96
BG00331.9± 10.67
BG00433.9± 12.56
BG00526.4± 7.18
BG00628.2± 10.25
BG00730.6± 12.57
BG00826.2± 9.07
BG00929.7± 11.07
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0016
BG0028
BG00311
BG0049
BG0058
BG0065
BG0076
BG00818
BG00973
Male
BG0008
BG0014
BG0024
BG0039
BG004
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
Black or African American
Title
Measurements
BG00010
BG00110
BG00212
BG00320
BG00422
BG00520
BG00621
BG00722
BG00851
BG009188
OG000
KAE609 10 mg SD
KAE609 10 mg once daily (QD) for 1 day
OG001
KAE609 10 mg QD 3 Days
KAE609 10 mg (QD) for 3 days
OG002
KAE609 25 mg SD
KAE609 25 mg once daily (QD) for 1 day
OG003
KAE609 25 mg QD 3 Days
KAE609 25 mg once daily (QD) for 3 days
OG004
KAE609 50 mg SD
KAE609 50 mg once daily (QD) for 1 day
OG005
KAE609 50 mg QD 3 Days
KAE609 50 mg once daily (QD) for 3 days
OG006
KAE609 75 mg SD
KAE609 75 mg once daily (QD) for 1 day
OG007
KAE609 150 mg SD
KAE609 150 mg once daily (QD) for 1 day
OG008
Pooled Coartem Control
control arm
Units
Counts
Participants
OG0009
OG00110
OG00212
OG00320
OG00421
OG00519
OG00621
OG00722
OG00851
Title
Denominators
Categories
Title
Measurements
OG00011.1(0.3 to 48.2)
OG0010(0.0 to 30.8)
OG0020(0.0 to 26.5)
OG0030(0.0 to 16.8)
OG0040(0.0 to 16.1)
OG0050(0.0 to 17.6)
OG0060(0.0 to 16.1)
OG0074.5(0.1 to 22.8)
OG0083.9(0.5 to 13.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Fisher Exact
2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem
0.391
Other
OG001
Fisher Exact
2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem
1
Other
OG002
Fisher Exact
2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem
1
Other
OG003
Fisher Exact
2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem
1
Other
OG004
Fisher Exact
2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem
1
Other
OG005
Fisher Exact
2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem
1
Other
OG006
Fisher Exact
2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem
1
Other
OG007
Fisher Exact
2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem
1
Other
Secondary
Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected and Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 15 and Day 29
PCR-corrected and PCR-uncorrected were evaluated at Days 15 and 29 (i.e., 14 and 28 days post-dose). The presence of parasitaemia after 7 days due to reinfection was considered as PCR-corrected ACPR. Missing blood smear data at Day 15 visit and thereafter were not considered as responder for the visit unless there was a later blood smear test indicating no parasitaemia.
Full Analysis Set (FAS). Only responders at each timepoint are included in the analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 15, Day 29
ID
Title
Description
OG000
KAE609 10 mg SD
KAE609 10 mg once daily (QD) for 1 day
OG001
KAE609 10 mg QD 3 Days
KAE609 10 mg (QD) for 3 days
OG002
KAE609 25 mg SD
KAE609 25 mg once daily (QD) for 1 day
OG003
KAE609 25 mg QD 3 Days
KAE609 25 mg once daily (QD) for 3 days
OG004
KAE609 50 mg SD
KAE609 50 mg once daily (QD) for 1 day
OG005
KAE609 50 mg QD 3 Days
KAE609 50 mg once daily (QD) for 3 days
OG006
KAE609 75 mg SD
KAE609 75 mg once daily (QD) for 1 day
OG007
KAE609 150 mg SD
KAE609 150 mg once daily (QD) for 1 day
OG008
Pooled Coartem Control
control arm
Units
Counts
Participants
OG00010
OG00110
OG00212
OG003
Title
Denominators
Categories
Day 15: PCR corrected
Title
Measurements
OG00090.0(55.50 to 99.75)
OG00190.0(55.50 to 99.75)
OG00283.3(51.59 to 97.91)
Secondary
Parasite Clearance Time (PCT)
Parasite Clearance Time (PCT) is defined as the time from the first dose until the first total and continued disappearance of asexual parasite forms which remained at least a further 48 hours. In case a patient received rescue medication before (parasite) clearance, the time to event was censored at the first use of rescue medication.
Full Analysis Set (FAS). Only participants with parasite at baseline and post-baseline assessment of parasite clearance at the time point are included in the analysis.
Posted
Mean
Standard Error
Hours
Day 29
ID
Title
Description
OG000
KAE609 10 mg SD
KAE609 10 mg once daily (QD) for 1 day
OG001
KAE609 10 mg QD 3 Days
KAE609 10 mg (QD) for 3 days
OG002
KAE609 25 mg SD
KAE609 25 mg once daily (QD) for 1 day
OG003
KAE609 25 mg QD 3 Days
KAE609 25 mg once daily (QD) for 3 days
OG004
KAE609 50 mg SD
KAE609 50 mg once daily (QD) for 1 day
OG005
KAE609 50 mg QD 3 Days
KAE609 50 mg once daily (QD) for 3 days
OG006
KAE609 75 mg SD
KAE609 75 mg once daily (QD) for 1 day
OG007
KAE609 150 mg SD
KAE609 150 mg once daily (QD) for 1 day
OG008
Pooled Coartem Control
control arm
Units
Counts
Participants
OG00010
OG00110
OG00212
OG003
Title
Denominators
Categories
Title
Measurements
OG00026.8± 5.44
OG00127.7± 4.96
OG00214.0± 2.63
OG003
Secondary
Fever Clearance Time (FCT)
Fever Clearance Time (FCT) is defined as the time from the first dose until the first time the axillary body temperature decreased below and remained below 37.5°C axillary or 38.0°C oral/tympanic/rectal for at least a further 24 hours. In case a patient received rescue medication before (fever) clearance, the time to event was censored at the first use of rescue medication.
Full Analysis Set (FAS). Only participants with fever at baseline and post-baseline assessment of fever clearance at the time point are included in the analysis.
Posted
Mean
Standard Error
Hours
Day 29
ID
Title
Description
OG000
KAE609 10 mg SD
KAE609 10 mg once daily (QD) for 1 day
OG001
KAE609 10 mg QD 3 Days
KAE609 10 mg (QD) for 3 days
OG002
KAE609 25 mg SD
KAE609 25 mg once daily (QD) for 1 day
OG003
KAE609 25 mg QD 3 Days
KAE609 25 mg once daily (QD) for 3 days
OG004
KAE609 50 mg SD
KAE609 50 mg once daily (QD) for 1 day
OG005
KAE609 50 mg QD 3 Days
KAE609 50 mg once daily (QD) for 3 days
OG006
KAE609 75 mg SD
KAE609 75 mg once daily (QD) for 1 day
OG007
KAE609 150 mg SD
KAE609 150 mg once daily (QD) for 1 day
OG008
Pooled Coartem Control
control arm
Units
Counts
Participants
OG00010
OG00110
OG00212
OG003
Title
Denominators
Categories
Title
Measurements
OG0003.9± NANA: Not Estimable due to number of events censored
OG0012.0± 0.02
OG002NA± NANA: Not Estimable due to number of events censored
Secondary
Time to Recrudescence and Reinfection at Study Day 29
Time to recrudescence is calculated from the date of first study medication to the date of first event. Participants without recrudescence/reinfection after Day 7 are censored at the time of treatment failure or at the time of last parasite assessment if no treatment failure occured.
Full Analysis Set (FAS). Only participants with clearance of initial infection before Day 15 and recrudescence/reinfection are included in the analysis.
Posted
Number
95% Confidence Interval
Event probability
Day 29
ID
Title
Description
OG000
KAE609 10 mg SD
KAE609 10 mg once daily (QD) for 1 day
OG001
KAE609 10 mg QD 3 Days
KAE609 10 mg (QD) for 3 days
OG002
KAE609 25 mg SD
KAE609 25 mg once daily (QD) for 1 day
OG003
KAE609 25 mg QD 3 Days
KAE609 25 mg once daily (QD) for 3 days
OG004
KAE609 50 mg SD
KAE609 50 mg once daily (QD) for 1 day
OG005
KAE609 50 mg QD 3 Days
KAE609 50 mg once daily (QD) for 3 days
OG006
KAE609 75 mg SD
KAE609 75 mg once daily (QD) for 1 day
OG007
KAE609 150 mg SD
KAE609 150 mg once daily (QD) for 1 day
OG008
Pooled Coartem Control
control arm
Units
Counts
Participants
OG0008
OG00110
OG00212
OG003
Title
Denominators
Categories
Recrudescence
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0022
ParticipantsOG003
Secondary
Maximum Peak Observed Concentration (Cmax)
Maximum Peak Observed Concentration (Cmax)
PK Analysis Set
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 1, Day 3
ID
Title
Description
OG000
KAE609 10 mg SD
KAE609 10 mg once daily (QD) for 1 day
OG001
KAE609 10 mg QD 3 Days
KAE609 10 mg (QD) for 3 days
OG002
KAE609 25 mg SD
KAE609 25 mg once daily (QD) for 1 day
OG003
KAE609 25 mg QD 3 Days
KAE609 25 mg once daily (QD) for 3 days
OG004
KAE609 50 mg SD
KAE609 50 mg once daily (QD) for 1 day
OG005
KAE609 50 mg QD 3 Days
KAE609 50 mg once daily (QD) for 3 days
OG006
KAE609 75 mg SD
KAE609 75 mg once daily (QD) for 1 day
OG007
KAE609 150 mg SD
KAE609 150 mg once daily (QD) for 1 day
Units
Counts
Participants
OG0009
OG00110
OG00212
OG003
Title
Denominators
Categories
Day 1
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG00212
ParticipantsOG003
Secondary
Tmax
Tmax
PK Analysis Set
Posted
Median
Full Range
Hour
Day 1, Day 3
ID
Title
Description
OG000
KAE609 10 mg SD
KAE609 10 mg once daily (QD) for 1 day
OG001
KAE609 10 mg QD 3 Days
KAE609 10 mg (QD) for 3 days
OG002
KAE609 25 mg SD
KAE609 25 mg once daily (QD) for 1 day
OG003
KAE609 25 mg QD 3 Days
KAE609 25 mg once daily (QD) for 3 days
OG004
KAE609 50 mg SD
KAE609 50 mg once daily (QD) for 1 day
OG005
KAE609 50 mg QD 3 Days
KAE609 50 mg once daily (QD) for 3 days
OG006
KAE609 75 mg SD
KAE609 75 mg once daily (QD) for 1 day
OG007
KAE609 150 mg SD
KAE609 150 mg once daily (QD) for 1 day
Units
Counts
Participants
OG0009
OG00110
OG00212
OG003
Title
Denominators
Categories
Day 1
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG00212
ParticipantsOG003
Secondary
AUC0-24
AUC0-24
PK Analysis Set
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ug/mL
Day 1, Day 3
ID
Title
Description
OG000
KAE609 10 mg SD
KAE609 10 mg once daily (QD) for 1 day
OG001
KAE609 10 mg QD 3 Days
KAE609 10 mg (QD) for 3 days
OG002
KAE609 25 mg SD
KAE609 25 mg once daily (QD) for 1 day
OG003
KAE609 25 mg QD 3 Days
KAE609 25 mg once daily (QD) for 3 days
OG004
KAE609 50 mg SD
KAE609 50 mg once daily (QD) for 1 day
OG005
KAE609 50 mg QD 3 Days
KAE609 50 mg once daily (QD) for 3 days
OG006
KAE609 75 mg SD
KAE609 75 mg once daily (QD) for 1 day
OG007
KAE609 150 mg SD
KAE609 150 mg once daily (QD) for 1 day
Units
Counts
Participants
OG0009
OG00110
OG00212
OG003
Title
Denominators
Categories
Day 1
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG00212
ParticipantsOG003
Secondary
Half-life (T^1/2)
Half-life (T^1/2)
PK Analysis Set
Posted
Mean
Standard Deviation
Hour
Upto day 15 post dose
ID
Title
Description
OG000
KAE609 10 mg SD
KAE609 10 mg once daily (QD) for 1 day
OG001
KAE609 10 mg QD 3 Days
KAE609 10 mg (QD) for 3 days
OG002
KAE609 25 mg SD
KAE609 25 mg once daily (QD) for 1 day
OG003
KAE609 25 mg QD 3 Days
KAE609 25 mg once daily (QD) for 3 days
OG004
KAE609 50 mg SD
KAE609 50 mg once daily (QD) for 1 day
OG005
KAE609 50 mg QD 3 Days
KAE609 50 mg once daily (QD) for 3 days
OG006
KAE609 75 mg SD
KAE609 75 mg once daily (QD) for 1 day
OG007
KAE609 150 mg SD
KAE609 150 mg once daily (QD) for 1 day
Units
Counts
Participants
OG0009
OG00110
OG00212
OG003
Title
Denominators
Categories
Day 1
ParticipantsOG0008
ParticipantsOG0013
ParticipantsOG00211
ParticipantsOG003
10
0
10
9
10
EG001
KAE609 10mg QD@3 Days
KAE609 10mg QD@3 days
0
10
0
10
8
10
EG002
KAE609 25mg SD
KAE609 25mg SD
0
12
0
12
10
12
EG003
KAE609 25mg QD@3 Days
KAE609 25mg QD@3 days
0
20
0
20
10
20
EG004
KAE609 50mg SD
KAE609 50mg SD
0
21
0
21
9
21
EG005
KAE609 50mg QD@3 Days
KAE609 50mg QD@3 days
0
19
1
19
16
19
EG006
KAE609 75mg SD
KAE609 75mg SD
0
21
2
21
15
21
EG007
KAE609 150mg SD
KAE609 150mg SD
0
22
1
22
12
22
EG008
Pooled Coartem
Pooled Coartem
0
51
1
51
25
51
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0050 affected19 at risk
EG0061 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
Alanine aminotransferase increased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0050 affected19 at risk
EG0060 affected21 at risk
EG0071 affected22 at risk
EG0080 affected51 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0050 affected19 at risk
EG0061 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
Blood bilirubin increased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0051 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0081 affected51 at risk
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0041 affected21 at risk
EG0050 affected19 at risk
EG0060 affected21 at risk
EG0071 affected22 at risk
EG0083 affected51 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0050 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0050 affected19 at risk
EG0060 affected21 at risk
EG0071 affected22 at risk
EG0083 affected51 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0050 affected19 at risk
EG0061 affected21 at risk
EG0070 affected22 at risk
EG0081 affected51 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0021 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0050 affected19 at risk
EG0061 affected21 at risk
EG0070 affected22 at risk
EG0083 affected51 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0050 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
Gastritis
Gastrointestinal disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0050 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
Asthenia
General disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0042 affected21 at risk
EG0050 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
Pain
General disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0021 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0050 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
Pyrexia
General disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0041 affected21 at risk
EG0050 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0082 affected51 at risk
Treatment failure
General disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0023 affected12 at risk
EG0031 affected20 at risk
EG0040 affected21 at risk
EG0051 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0082 affected51 at risk
Vessel puncture site pain
General disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0051 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0082 affected51 at risk
Bronchitis
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0051 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
Gastroenteritis
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected12 at risk
EG0031 affected20 at risk
EG0040 affected21 at risk
EG0051 affected19 at risk
EG0061 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
Influenza
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0031 affected20 at risk
EG0040 affected21 at risk
EG0053 affected19 at risk
EG0062 affected21 at risk
EG0073 affected22 at risk
EG0082 affected51 at risk
Malaria
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0022 affected12 at risk
EG0034 affected20 at risk
EG0044 affected21 at risk
EG0055 affected19 at risk
EG0065 affected21 at risk
EG0079 affected22 at risk
EG0081 affected51 at risk
Oral herpes
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0051 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
Parasitic gastroenteritis
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0051 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
Pneumonia
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0050 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0051 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
Urinary tract infection
Infections and infestations
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0050 affected19 at risk
EG0060 affected21 at risk
EG0071 affected22 at risk
EG0080 affected51 at risk
Mouth injury
Injury, poisoning and procedural complications
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0051 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
Alanine aminotransferase increased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0031 affected20 at risk
EG0041 affected21 at risk
EG0050 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0083 affected51 at risk
Aspartate aminotransferase increased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0041 affected21 at risk
EG0050 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0083 affected51 at risk
Bacterial test positive
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0051 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
Gamma-glutamyltransferase increased
Investigations
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected12 at risk
EG0031 affected20 at risk
EG0040 affected21 at risk
EG0050 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0081 affected51 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0050 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0050 affected19 at risk
EG0060 affected21 at risk
EG0071 affected22 at risk
EG0080 affected51 at risk
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0050 affected19 at risk
EG0062 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0021 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0050 affected19 at risk
EG0061 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected10 at risk
EG0021 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0050 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0050 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
Dizziness
Nervous system disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected10 at risk
EG0021 affected12 at risk
EG0031 affected20 at risk
EG0040 affected21 at risk
EG0050 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0081 affected51 at risk
Headache
Nervous system disorders
MedDRA (22.1)
Systematic Assessment
EG0003 affected10 at risk
EG0015 affected10 at risk
EG0021 affected12 at risk
EG0031 affected20 at risk
EG0042 affected21 at risk
EG0052 affected19 at risk
EG0065 affected21 at risk
EG0070 affected22 at risk
EG0089 affected51 at risk
Haematuria
Renal and urinary disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0051 affected19 at risk
EG0061 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0021 affected12 at risk
EG0031 affected20 at risk
EG0041 affected21 at risk
EG0052 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0081 affected51 at risk
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0051 affected19 at risk
EG0060 affected21 at risk
EG0071 affected22 at risk
EG0080 affected51 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0031 affected20 at risk
EG0040 affected21 at risk
EG0051 affected19 at risk
EG0061 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA (22.1)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected10 at risk
EG0020 affected12 at risk
EG0031 affected20 at risk
EG0040 affected21 at risk
EG0050 affected19 at risk
EG0061 affected21 at risk
EG0070 affected22 at risk
EG0081 affected51 at risk
Phlebitis
Vascular disorders
MedDRA (22.1)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected10 at risk
EG0021 affected12 at risk
EG0030 affected20 at risk
EG0040 affected21 at risk
EG0050 affected19 at risk
EG0060 affected21 at risk
EG0070 affected22 at risk
EG0080 affected51 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.