A Study of the Safety, Tolerance, and Pharmacokinetics of... | NCT01716234 | Trialant
NCT01716234
Sponsor
Merck Sharp & Dohme LLC
Status
Terminated
Last Update Posted
Aug 27, 2018Actual
Enrollment
142Actual
Phase
Phase 1
Conditions
Fungal Infections
Interventions
Posaconazole 12 mg/kg/day BID
Posaconazole 18 mg/kg/day BID
Posaconazole 18 mg/kg/day TID
Posaconazole 12 mg/kg/day TID
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT01716234
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
P03579
Secondary IDs
ID
Type
Description
Link
2007-004645-15
EudraCT Number
MK-5592-032
Other Identifier
Merck
Brief Title
A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)
Official Title
Phase 1B Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children With Neutropenia (P03579)
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Jul 2018
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Study was terminated early (10 July 2015) based on preliminary analysis of pharmacokinetic data.
Expanded Access Info
No
Start Date
Apr 17, 2008Actual
Primary Completion Date
Apr 1, 2015Actual
Completion Date
Apr 1, 2015Actual
First Submitted Date
Oct 25, 2012
First Submission Date that Met QC Criteria
Oct 25, 2012
First Posted Date
Oct 29, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 15, 2016
Results First Submitted that Met QC Criteria
Mar 15, 2016
Results First Posted Date
Apr 15, 2016Estimated
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
Jul 27, 2018
Last Update Posted Date
Aug 27, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and tolerability of oral posaconazole in immunocompromised children with neutropenia or expected neutropenia.
Detailed Description
Not provided
Conditions Module
Conditions
Fungal Infections
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
142Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
POS 12 BID 2 to <7 Years
Experimental
Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
Drug: Posaconazole 12 mg/kg/day BID
POS 12 BID 7 to <18 Years
Experimental
Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
Drug: Posaconazole 12 mg/kg/day BID
POS 18 BID 2 to <7 Years
Experimental
Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
Drug: Posaconazole 18 mg/kg/day BID
POS 18 BID 7 to <18 Years
Experimental
Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
Drug: Posaconazole 18 mg/kg/day BID
POS 18 TID 2 to <7 Years
Experimental
Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)
Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 1. The 12-hour sample was not obtained for the TID dose groups. Day 1 pharmacokinetic samples were not collected for participants 3 months to <2 years of age weighing <6.5 kg.
Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups)
Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)
Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 7 (steady state). The 12-hour sample was not obtained for the TID dose groups. The target Cavg range was 500 to <2500 ng/mL.
Up to 12 hours after the first dose on Day 7 (BID dose groups) or up to 8 hours after the first dose on Day 7 (TID dose
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With an Adverse Event
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.
Up to Day 58
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Documented or anticipated neutropenia expected to last at least 7 days and only in the following clinical situations: acute leukemia; myelodysplasia; severe aplastic anemia; autologous hematopoietic stem cell transplantation (HSCT) recipients; high risk neuroblastoma; advanced stage non-Hodgkin's lymphoma; recipients of allogeneic HSCT during the pre-engraftment (neutropenia) period
Participants of child-bearing potential must use a medically accepted method of
contraception throughout the study and for at least 30 days after stopping study medication, unless they are surgically or medically sterile or agree to remain abstinent.
Exclusion Criteria:
Proven invasive fungal infection (IFI) before study entry
Severe nausea and/or vomiting at screening
Received posaconazole within 10 days before screening
Unable to receive study drug by mouth or via an intestinal (enteral) tube
Females who are pregnant, intend to become pregnant during the study, or are breastfeeding
History of anaphylaxis attributed to the azole class of antifungal agents
Arrieta AC, Sung L, Bradley JS, Zwaan CM, Gates D, Waskin H, Carmelitano P, Groll AH, Lehrnbecher T, Mangin E, Joshi A, Kartsonis NA, Walsh TJ, Paschke A. A non-randomized trial to assess the safety, tolerability, and pharmacokinetics of posaconazole oral suspension in immunocompromised children with neutropenia. PLoS One. 2019 Mar 26;14(3):e0212837. doi: 10.1371/journal.pone.0212837. eCollection 2019.
A total of 160 participants were screened, 142 were randomized / enrolled, and 136 were treated. An arm planned for participants aged 3 months to <2 years to receive posaconazole 18 mg/kg/day TID was never initiated.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
POS 12 BID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
FG001
POS 12 BID 7 to <18 Years
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
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
Canada
Germany
Greece
Netherlands
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel 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: Posaconazole 18 mg/kg/day TID
POS 18 TID 7 to <18 Years
Experimental
Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
Drug: Posaconazole 18 mg/kg/day TID
POS 12 TID 3 months to <2 Years
Experimental
Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
Number of Participants With an Adverse Event Leading to Study Drug Discontinuation
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.
Up to Day 28
Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
FG002
POS 18 BID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
FG003
POS 18 BID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
FG004
POS 18 TID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
FG005
POS 18 TID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
FG006
POS 12 TID 3 Months to <2 Years
Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
FG00024 subjects
FG00122 subjects
FG00220 subjects
FG00328 subjects
FG00415 subjects
FG00532 subjects
FG0061 subjects
Treated
FG00022 subjects
FG00121 subjects
FG00219 subjects
FG00328 subjects
FG00415 subjects
FG00530 subjects
FG0061 subjects
COMPLETED
FG00014 subjects
FG00112 subjects
FG00215 subjects
FG00316 subjects
FG00410 subjects
FG00518 subjects
FG0061 subjects
NOT COMPLETED
FG00010 subjects
FG00110 subjects
FG0025 subjects
FG00312 subjects
FG0045 subjects
FG00514 subjects
FG0060 subjects
Type
Comment
Reasons
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Did not meet protocol eligibility
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Adverse Event
FG0007 subjects
FG00110 subjects
FG0022 subjects
FG0038 subjects
FG004
Withdrawal by Subject
FG0003 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
POS 12 BID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
BG001
POS 12 BID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
BG002
POS 18 BID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
BG003
POS 18 BID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
BG004
POS 18 TID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
BG005
POS 18 TID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
BG006
POS 12 TID 3 Months to <2 Years
Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00024
BG00122
BG00220
BG00328
BG00415
BG00532
BG0061
BG007142
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG0004.0± 1.3(2 to 7)
BG00111.9± 3.5(7 to 17)
BG0024.4± 1.5(2 to 7)
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00010
BG00112
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
Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)
Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 1. The 12-hour sample was not obtained for the TID dose groups. Day 1 pharmacokinetic samples were not collected for participants 3 months to <2 years of age weighing <6.5 kg.
The pharmacokinetic evaluable population included all treated participants with evaluable samples applicable to the endpoint.
Posted
Mean
Standard Deviation
ng/mL
Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups)
ID
Title
Description
OG000
POS 12 BID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
OG001
POS 12 BID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
OG002
POS 18 BID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
OG003
POS 18 BID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
OG004
POS 18 TID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
OG005
POS 18 TID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
OG006
POS 12 TID 3 Months to <2 Years
Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
Units
Counts
Participants
OG00022
OG00119
OG00212
OG003
Title
Denominators
Categories
Title
Measurements
OG000122± 101
OG001107± 92.5
OG002112± 86.9
OG003
Primary
Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)
Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 7 (steady state). The 12-hour sample was not obtained for the TID dose groups. The target Cavg range was 500 to <2500 ng/mL.
The pharmacokinetic evaluable population included all treated participants with evaluable samples applicable to the endpoint.
Posted
Mean
Standard Deviation
ng/mL
Up to 12 hours after the first dose on Day 7 (BID dose groups) or up to 8 hours after the first dose on Day 7 (TID dose
ID
Title
Description
OG000
POS 12 BID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
OG001
POS 12 BID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
OG002
POS 18 BID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
Secondary
Number of Participants With an Adverse Event
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.
The population analyzed was all treated participants.
Posted
Number
Participants
Up to Day 58
ID
Title
Description
OG000
POS 12 BID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
OG001
POS 12 BID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
OG002
POS 18 BID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
OG003
Secondary
Number of Participants With an Adverse Event Leading to Study Drug Discontinuation
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.
The population analyzed was all treated participants.
Posted
Number
Participants
Up to Day 28
ID
Title
Description
OG000
POS 12 BID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
OG001
POS 12 BID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
OG002
POS 18 BID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
Time Frame
All AEs: from Day 1 up to Day 39; SAEs: up to Day 58.
Description
The population analyzed is all treated participants.
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
POS 12 BID 2 to <7 Yrs
Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
5
22
21
22
EG001
POS 12 BID 7 to <18 Yrs
Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
3
21
20
21
EG002
POS 18 BID 2 to <7 Yrs
Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
1
19
16
19
EG003
POS 18 BID 7 to <18 Yrs
Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
7
28
26
28
EG004
POS 18 TID 2 to <7 Yrs
Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
7
15
13
15
EG005
POS 18 TID 7 to <18 Yrs
Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
11
30
28
30
EG006
POS 12 TID 3 Months to <2 Yrs
Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
1
1
1
1
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected19 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected30 at risk
EG0060 events0 affected1 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Hypothermia
General disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Mucosal inflammation
General disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Multi-organ failure
General disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Pyrexia
General disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Hepatic haemorrhage
Hepatobiliary disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Hepatic vein occlusion
Hepatobiliary disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Hepatobiliary disease
Hepatobiliary disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Venoocclusive liver disease
Hepatobiliary disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Catheter site cellulitis
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Pneumonia klebsiella
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Puncture site infection
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Sepsis
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Streptococcal bacteraemia
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Chemotherapeutic drug level increased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Electrocardiogram T wave inversion
Investigations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Transaminases increased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Burkitt's lymphoma recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Headache
Nervous system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Seizure
Nervous system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Hypotension
Vascular disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA version 18.0
Systematic Assessment
EG0006 events4 affected22 at risk
EG0013 events2 affected21 at risk
EG0026 events3 affected19 at risk
EG00312 events8 affected28 at risk
EG00411 events3 affected15 at risk
EG00512 events6 affected30 at risk
EG0060 events0 affected1 at risk
Coagulopathy
Blood and lymphatic system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0014 events4 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA version 18.0
Systematic Assessment
EG0005 events5 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA version 18.0
Systematic Assessment
EG0002 events2 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA version 18.0
Systematic Assessment
EG0003 events3 affected4 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA version 18.0
Systematic Assessment
EG00019 events8 affected22 at risk
EG00115 events7 affected21 at risk
EG00210 events3 affected19 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA version 18.0
Systematic Assessment
EG0003 events3 affected22 at risk
EG0012 events2 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Antithrombin III deficiency
Congenital, familial and genetic disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Conjunctival hyperaemia
Eye disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Dry eye
Eye disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Eye movement disorder
Eye disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Eye pruritus
Eye disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0022 events2 affected19 at risk
EG003
Eye swelling
Eye disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0007 events7 affected22 at risk
EG0017 events6 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0002 events2 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0014 events4 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0005 events5 affected22 at risk
EG0013 events3 affected21 at risk
EG0025 events3 affected19 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Loose tooth
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0008 events5 affected22 at risk
EG0013 events3 affected21 at risk
EG0025 events2 affected19 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0012 events2 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0004 events3 affected22 at risk
EG0010 events0 affected21 at risk
EG0022 events2 affected19 at risk
EG003
Tongue coated
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG00013 events8 affected22 at risk
EG0015 events3 affected21 at risk
EG0026 events5 affected19 at risk
EG003
Catheter site erythema
General disorders
MedDRA version 18.0
Systematic Assessment
EG0002 events2 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Catheter site pruritus
General disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Chills
General disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Device occlusion
General disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Fatigue
General disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Mucosal inflammation
General disorders
MedDRA version 18.0
Systematic Assessment
EG0009 events9 affected22 at risk
EG0013 events3 affected21 at risk
EG0025 events2 affected19 at risk
EG003
Oedema
General disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Pain
General disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0023 events2 affected19 at risk
EG003
Pyrexia
General disorders
MedDRA version 18.0
Systematic Assessment
EG00014 events13 affected22 at risk
EG0019 events8 affected21 at risk
EG0023 events3 affected19 at risk
EG003
Vessel puncture site pain
General disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Engraftment syndrome
Immune system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Graft versus host disease in skin
Immune system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Alpha haemolytic streptococcal infection
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0012 events2 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Gingivitis
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Infection
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Pseudomonal bacteraemia
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Rhinitis
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0023 events2 affected19 at risk
EG003
Viral infection
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Vulvitis
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Allergic transfusion reaction
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Procedural headache
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Biopsy skin
Investigations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Fluid balance positive
Investigations
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0015 events3 affected21 at risk
EG0020 events0 affected19 at risk
EG003
International normalised ratio decreased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0022 events1 affected19 at risk
EG003
Platelet count decreased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG00211 events2 affected19 at risk
EG003
Transaminases increased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0002 events2 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected19 at risk
EG003
White blood cell count decreased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0023 events1 affected19 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Hyperalbuminaemia
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0012 events1 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0002 events2 affected22 at risk
EG0016 events3 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0014 events4 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA version 18.0
Systematic Assessment
EG0002 events2 affected22 at risk
EG0012 events2 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0012 events2 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0012 events2 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Headache
Nervous system disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0012 events2 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Abnormal behavior
Psychiatric disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Agitation
Psychiatric disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0012 events1 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0012 events2 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Genital pain
Reproductive system and breast disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Genital rash
Reproductive system and breast disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Pruritus genital
Reproductive system and breast disorders
MedDRA version 18.0
Systematic Assessment
EG0002 events2 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0002 events2 affected22 at risk
EG0013 events3 affected21 at risk
EG0023 events3 affected19 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0011 events1 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0002 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0023 events1 affected19 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0002 events2 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0002 events2 affected22 at risk
EG0012 events2 affected21 at risk
EG0022 events2 affected19 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0003 events3 affected22 at risk
EG0015 events5 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0004 events4 affected22 at risk
EG0011 events1 affected21 at risk
EG0023 events2 affected19 at risk
EG003
Red man syndrome
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Central venous catheter removal
Surgical and medical procedures
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Central venous catheterisation
Surgical and medical procedures
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Flushing
Vascular disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 18.0
Systematic Assessment
EG0005 events4 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Hypotension
Vascular disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0013 events3 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Venoocclusive disease
Vascular disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0020 events0 affected19 at risk
EG003
Photophobia
Eye disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Local swelling
General disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Oedema peripheral
General disorders
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Cellulitis
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Cystitis
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Sinusitis
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Streptococcal infection
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Viraemia
Infections and infestations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA version 18.0
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Blood glucose increased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Weight increased
Investigations
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Genital ulceration
Reproductive system and breast disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Penile oedema
Reproductive system and breast disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Pallor
Vascular disorders
MedDRA version 18.0
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected21 at risk
EG0021 events1 affected19 at risk
EG003
Only 1 participant was enrolled in the POS 12 TID 3 months to <2 years group, limiting conclusions that may be drawn for pharmacokinetics or safety.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation with regard to proprietary information, accuracy, fair balance, and compliance.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
ID
Term
D009181
Mycoses
Ancestor Terms
ID
Term
D001423
Bacterial Infections and Mycoses
D007239
Infections
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C101425
posaconazole
C494814
BID protein, human
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0054 subjects
FG0060 subjects
3 subjects
FG0056 subjects
FG0060 subjects
1 subjects
FG0053 subjects
FG0060 subjects
BG003
12.2
± 3.2
(7 to 18)
BG0044.1± 1.3(3 to 7)
BG00513.1± 3.0(7 to 18)
BG0060.9± 0(1 to 1)
BG0078.9± 4.9(1 to 18)
8
BG0039
BG0046
BG00514
BG0060
BG00759
Male
BG00014
BG00110
BG00212
BG00319
BG0049
BG00518
BG0061
BG00783
12
OG0045
OG00510
OG0061
113
± 100
OG00468.4± 40.4
OG00557.9± 30.2
OG00668.5± 0
OG003
POS 18 BID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
OG004
POS 18 TID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
OG005
POS 18 TID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
OG006
POS 12 TID 3 Months to <2 Years
Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
Units
Counts
Participants
OG00016
OG00114
OG00212
OG00312
OG0045
OG00510
OG0061
Title
Denominators
Categories
Title
Measurements
OG000604± 779
OG0011050± 789
OG002485± 306
OG0031240± 1400
OG004620± 411
OG0051150± 750
OG006453± 0
POS 18 BID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
OG004
POS 18 TID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
OG005
POS 18 TID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
OG006
POS 12 TID 3 Months to <2 Years
Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
Units
Counts
Participants
OG00022
OG00121
OG00219
OG00328
OG00415
OG00530
OG0061
Title
Denominators
Categories
Title
Measurements
OG00021
OG00121
OG00216
OG00326
OG00413
OG00530
OG0061
OG003
POS 18 BID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
OG004
POS 18 TID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
OG005
POS 18 TID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
OG006
POS 12 TID 3 Months to <2 Years
Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.