Efficacy and Safety Study of Maribavir Treatment Compared... | NCT02931539 | Trialant
NCT02931539
Sponsor
Shire
Status
Completed
Last Update Posted
Nov 3, 2021Actual
Enrollment
352Actual
Phase
Phase 3
Conditions
Cytomegalovirus (CMV)
Interventions
Maribavir
Ganciclovir
Valganciclovir
Foscarnet
Cidofovir
Countries
United States
Australia
Austria
Belgium
Canada
Croatia
Denmark
France
Germany
Italy
Singapore
Spain
Switzerland
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02931539
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
SHP620-303
Secondary IDs
ID
Type
Description
Link
2015-004725-13
EudraCT Number
Brief Title
Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir
Official Title
A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir
Acronym
Not provided
Organization
TakedaINDUSTRY
Status Module
Record Verification Date
Sep 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
Dec 22, 2016Actual
Primary Completion Date
Aug 17, 2020Actual
Completion Date
Aug 17, 2020Actual
First Submitted Date
Sep 29, 2016
First Submission Date that Met QC Criteria
Oct 10, 2016
First Posted Date
Oct 13, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 9, 2021
Results First Submitted that Met QC Criteria
Sep 22, 2021
Results First Posted Date
Sep 23, 2021Actual
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 29, 2021
Last Update Posted Date
Nov 3, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ShireINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to compare the efficacy of maribavir to investigator-assigned anti-Cytomegalovirus (CMV) therapy in CMV viremia clearance in transplant recipients who are refractory or resistant to prior anti-CMV treatment.
Detailed Description
Not provided
Conditions Module
Conditions
Cytomegalovirus (CMV)
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
352Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Maribavir Treatment
Experimental
Participants will receive 400 milligrams (mg) (2x200 mg tablets) maribavir twice daily orally (doses separated by a minimum of 8 hours) for 8 weeks.
Drug: Maribavir
Investigator-Assigned Treatment
Active Comparator
Participants will receive anti-CMV agent best suited to treat the respective participant as per the investigator's prescribed dosing regimen for 8 weeks. Agents of choice include: ganciclovir, valganciclovir, foscarnet, or cidofovir.
Drug: Ganciclovir
Drug: Valganciclovir
Drug: Foscarnet
Drug: Cidofovir
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Maribavir
Drug
Maribavir 400 milligrams (mg) (2x200 mg tablets) will be administered twice daily for 8 weeks.
Maribavir Treatment
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (CMV Viremia Clearance) at End of Week 8
Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration less than (<) lower limit of quantification (LLOQ) that is, <137 International Units per milliliter (IU/mL) when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive postbaseline samples, separated by at least 5 days. Percentage of participants with confirmed CMV viremia clearance at end of study Week 8 regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy, and could not have received alternative anti-CMV treatment were reported.
Week 8
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at End of Week 8, Followed by Maintenance of Treatment Effect at Week 16
Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration \
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
The participant must be able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures. As applicable, a parent/both parents or legally authorized representative (LAR) must provide signature of informed consent and there must be documentation of assent by the participant before completing any study-related procedures.
The participant must be a recipient of hematopoietic stem cell or solid organ transplant.
The participant must have a documented CMV infection in whole blood or plasma, with a screening value of greater than or equal to (>=) 2730 international units per milliliter (IU/mL) in whole blood or >= 910 IU/mL in plasma in 2 consecutive assessments, separated by at least 1 day, as determined by local or central specialty laboratory quantitative polymerase chain reaction (qPCR) or comparable quantitative CMV DNA results. Both samples should be taken within 14 days prior to randomization with second sample obtained within 5 days prior to randomization. The same laboratory and same sample type (whole blood or plasma) must be used for these assessments.
The participant must have a current CMV infection that is refractory to the most recently administered of the four anti-CMV treatment agents. Refractory is defined as documented failure to achieve greater than (>) 1 log10 (common logarithm to base 10) decrease in CMV DNA level in whole blood or plasma after a 14 day or longer treatment period with intravenous (IV) ganciclovir/oral valganciclovir, IV foscarnet, or IV cidofovir.
a. Participants with documentation of 1 or more CMV genetic mutations associated with resistance to ganciclovir/valganciclovir, foscarnet, and/or cidofovir must also meet the definition of refractory CMV infection.
The Investigator must be willing to treat the participant with at least one of the available anti-CMV drugs (ganciclovir, valganciclovir, foscarnet, or cidofovir). Note: Combination therapy with foscarnet and cidofovir is not permitted in the investigator-assigned anti-CMV treatment (IAT) arm due to the potential for serious nephrotoxicity.
The participant must be >= 12 years of age at the time of consent.
The participant must weigh >= 35 kilogram (kg).
The participant must have all of the following results as part of screening laboratory assessments (results from either the central laboratory or a local laboratory can be used for qualification):
Estimated glomerular filtration rate (eGFR) > 30 (milliliters per minute (mL/min) /1.73 square meter (m^2) as assessed by Modification of Diet in Renal Disease (MDRD) formula for participants >= 18 years of age or Schwartz formula for participants less than (<) 18 years of age.
The participant must have a negative serum beta-human chorionic gonadotropin (beta-HCG) pregnancy test at screening, if a female of child bearing potential. Additional urine pregnancy tests may be done per institutional requirements. Sexually active females of child bearing potential must agree to comply with any applicable contraceptive requirements of the protocol. If male, must agree to use an acceptable method of birth control, as defined in the protocol, during the study treatment administration period and for 90 days afterward if treated with maribavir, ganciclovir, valganciclovir, or cidofovir and for 180 days afterward if treated with foscarnet.
The participant must be able to swallow tablets, or receive tablets crushed and/or dispensed in water via nasogastric or orogastric tube.
The participant must be willing and have an understanding and ability to fully comply with study procedures and restrictions defined in the protocol.
The participant must be willing to provide necessary samples (example [e.g,] biopsy) for the diagnosis of tissue invasive CMV disease at baseline as determined by the Investigator.
The participant must have a life expectancy of >= 8 weeks.
Exclusion Criteria:
Have a current CMV infection that is considered refractory or resistant due to inadequate adherence to prior anti-CMV treatment, to the best knowledge of the Investigator.
Require ganciclovir, valganciclovir, foscarnet, or cidofovir administration for conditions other than CMV when study treatment is initiated (example: herpes simplex virus (HSV) coinfection requiring use of any of these agents after the randomization) or would need a coadministration with maribavir for CMV infection. NOTE: A participant who is not continuing with the same anti-CMV drug(s) (ganciclovir, valganciclovir or foscarnet) for the study treatment (if randomized to the investigator assigned anti-CMV treatment arm), must discontinue their use before the first dose of study drug. If participant is currently being treated with cidofovir and is assigned another anti-CMV therapy by the investigator, the participant must discontinue its use at least 14 days prior to randomization at Visit 2/Day 0 and the first dose of study treatment.
Be receiving leflunomide, letermovir, or artesunate when study treatment is initiated. NOTE: Participants receiving leflunomide must discontinue the use at least 14 days prior to randomization at Visit 2/Day 0 and the first dose of study treatment. Participants receiving letermovir must discontinue use at least 3 days prior to the first dose of study treatment. Participants receiving artesunate must discontinue the use prior to the first dose of study treatment.
Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the first dose of study treatment that would preclude administration of oral/enteral medication.
Have known hypersensitivity to the active substance or to an excipient for a study treatment.
Have tissue invasive CMV disease with central nervous system involvement including the retina (example, CMV retinitis).
Have serum aspartate aminotransferase (AST) > 5 times upper limit of normal (ULN) at screening, or serum alanine aminotransferase (ALT) > 5 times ULN at screening, or total bilirubin >= 3.0 x ULN at screening (except for documented Gilbert's syndrome), by local or central lab. Participants with biopsy confirmed CMV hepatitis will not be excluded from study participation despite AST or ALT > 5 times ULN at screening.
Have known positive results for human immunodeficiency virus (HIV). Participants must have a confirmed negative HIV test result within 3 months of study entry or, if unavailable, be tested by a local laboratory during the screening period.
Require mechanical ventilation or vasopressors for hemodynamic support at the time of enrollment.
Be female and pregnant or breast feeding.
Have previously received maribavir.
Have received any investigational agent with known anti-CMV activity within 30 days before initiation of study treatment or investigational CMV vaccine at any time.
Have received any unapproved agent or device within 30 days before initiation of study treatment.
Have active malignancy with the exception of nonmelanoma skin cancer. Participants who have had a hematopoietic stem cell transplant (HSCT) and who experience relapse or progression of the malignancy as per investigator's opinion are not to be enrolled.
Be undergoing treatment for acute or chronic hepatitis C.
Have any clinically significant medical or surgical condition that, in the investigator's opinion, could interfere with the interpretation of study results, contraindicate the administration of the assigned study treatment, or compromise the safety or well-being of the participant.
Kamar N, Avery RK, Bo T, Gu J, Kumar D, Witzke O. Association Between Cytomegalovirus Viremia Clearance and Post-Solid Organ Transplant Mortality in Patients With Refractory Cytomegalovirus Infection: SOLSTICE Post Hoc Analysis. Transpl Int. 2025 Nov 26;38:15331. doi: 10.3389/ti.2025.15331. eCollection 2025.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
Not provided
Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with cytomegalovirus (CMV) infections were enrolled and randomized into two treatment groups: IAT (control), and Maribavir 400 mg. Participants randomized to IAT treatment arm, if met the stringent criteria for lack of improvement/worsening of CMV infection, considered eligible for entry into Maribavir rescue arm at Week 3 based on medical monitor review. As planned, combined data has been reported for IAT control group.
Recruitment Details
This study was conducted at 94 sites in North America, Europe, and Asia Pacific between 22 December 2016 (first participant first visit) and 17 August 2020 (last participant last visit).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Investigator-assigned Anti-CMV Treatment (IAT)
Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
FG001
Maribavir 400 mg
Periods
Title
Milestones
Reasons Not Completed
Period 1: Treatment Phase
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Dec 7, 2018
Aug 9, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
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
SHP620
Ganciclovir
Drug
Ganciclovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.
Investigator-Assigned Treatment
Valganciclovir
Drug
Valganciclovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.
Investigator-Assigned Treatment
Foscarnet
Drug
Foscarnet as per the investigator's prescribed dosing regimen will be administered for 8 weeks.
Investigator-Assigned Treatment
Cidofovir
Drug
Cidofovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.
Investigator-Assigned Treatment
Up to Week 16
Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment
Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration \
At Week 8 through Weeks 12, 16 and 20
Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control After Receiving 8 Weeks of Study-assigned Treatment Through Weeks 12, 16 and 20
Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration \
At Week 8 through Weeks 12, 16 and 20
Percentage of Participants Who Maintained CMV Viremia Clearance and CMV Infection Symptom Control at the End of Study Week 8 Through Weeks 12 and 20 Regardless of Whether Either Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy
Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration \
At Week 8 through Weeks 12 and 20
Percentage of Participants With Recurrence of CMV Viremia During the First 8 Weeks of Study Regardless of Whether Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy
Recurrence of CMV viremia was defined as plasma CMV DNA concentration greater than or equal to (>=) LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy. Percentage of participants with recurrence of CMV viremia during the first 8 weeks of study regardless of whether study-assigned treatment was discontinued before 8 weeks of therapy were reported.
At Week 8
Percentage of Participants With Recurrence of CMV Viremia During the 12 Weeks Follow-up Period Regardless of Whether Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy
Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy. Percentage of participants with recurrence of CMV viremia during the 12 weeks follow-up period regardless of whether study-assigned treatment was discontinued before 8 weeks of therapy were reported.
End of Week 8 up to Week 20 (12 weeks follow-up period)
Percentage of Participants With Recurrence of CMV Viremia at Any Time on Study Regardless of Whether Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy
Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy. Percentage of participants with recurrence of CMV viremia during at any time on study regardless of whether study-assigned treatment was discontinued before 8 weeks of therapy were reported.
Baseline up to Week 20
Percentage of Participants Who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the First 8 Weeks of the Treatment
Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants with recurrence of CMV viremia during the first 8 Weeks of the treatment who completed 8 weeks of study-assigned treatment were reported.
Baseline up to Week 8
Percentage of Participants Who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the 12 Weeks of Follow-up Period
Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants who completed 8 weeks of study-assigned treatment with recurrence of CMV viremia during the 12 weeks of follow-up period were reported.
End of Week 8 up to Week 20 (12 weeks follow-up period)
Percentage of Participants Who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the 20 Weeks of Study
Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants with Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants who completed 8 weeks of study-assigned treatment with recurrence of CMV viremia during the 20 weeks of study were reported.
Baseline up to Week 20
Percentage of Participants With Recurrence of CMV Viremia While on Study-assigned Treatment
Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants with recurrence of CMV viremia while on study-assigned treatment period were reported.
Baseline up to termination of study treatment (up to Week 8)
Percentage of Participants With Recurrence of CMV Viremia While Off Study-assigned Treatment During Follow-up Period
Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants with recurrence of CMV viremia while off study-assigned treatment during follow-up period were reported.
Termination of study treatment (Week 8) up to the End of the Study (Week 20)
Number of Participants Who Had Maribavir CMV Resistance at Baseline
Resistance-associated amino acid substitutions (RASs) to maribavir are known to generally map to the pUL97 and pUL27 genes. Genotyping was performed to identify RASs mapping to the pUL97 and pUL27 genes. Number of participants who had maribavir CMV resistance at baseline were reported.
At Baseline
Number of Participants Who Had Post-baseline Resistance to Maribavir
Resistance-associated amino acid substitutions (RASs) to maribavir are known to generally map to the pUL97 and pUL27 genes. Genotyping was performed to identify RASs mapping to the pUL97 and pUL27 genes. Number of participants who had post-baseline resistance to maribavir were reported.
After first dose of study drug up to Week 20
Number of Participants With All-cause Mortality by the End of the Study
All-cause mortality was analyzed by the end of study regardless of the use of rescue treatment or alternative anti-CMV treatment. Number of participants who died during the entire study period were reported.
From enrollment up to end of study (approximately 44 months)
Time to All Cause Mortality
The time to all-cause mortality by the end of the study participation in days was calculated. Participants who were alive at the last study follow-up (regardless of use of rescue or alternative anti-CMV treatment), withdrew from study or were lost to follow-up were censored at the date of last contact.
From enrollment to last serious adverse event (SAE) follow-up (approximately Week 28)
Percentage of Participants Who Achieved Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at End of Week 8 After Starting Maribavir Rescue Treatment
Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration \
From start of maribavir rescue treatment through 8 weeks
Percentage of Participants Receiving Maribavir Rescue Treatment Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at Week 8 With Maintenance of Effect Through Week 16
Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration \
Up to Week 16
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs During the On-treatment Observation Period
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Serious AE was any untoward medical occurrence (whether considered to be related to study-assigned treatment or not) that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital abnormality/birth defect, or was an important medical event. TEAEs was defined as any adverse events (classified by preferred term) that had a start date on or after the first dose of study treatment or that had a start date before the date of first dose of study treatment, but increased in severity after the first dose of study treatment.
Baseline up to 7 days or 21 days (if cidofovir used) after the last dose of study treatment (up to Week 8)
Predose Concentration (Cmin) of Maribavir
Cmin of maribavir was reported.
Predose at Week 1, 4 and 8
Area Under the Concentration Time Curve Over the 12-hour Dosing Interval at Steady State (AUC0-tau) of Marivabir for Adolescent Participants
AUC0-tau of maribavir for adolescent participants was planned to be reported.
Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose, Week 4: Pre-morning dose, and Week 8: Pre-morning dose and 2-4 hour post morning dose
Maximum Plasma Concentration (Cmax) of Maribavir for Adolescent Participants
Cmax of maribavir for adolescent participants was planned to be reported.
Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose
Time When Maximum Concentration is Observed (Tmax) of Maribavir for Adolescent Participants
Tmax of maribavir for adolescent participants was planned to be reported.
Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose
Apparent Oral Clearance (CL/F) of Maribavir for Adolescent Participants
Apparent oral clearance (CL/F) of maribavir for adolescent participants was planned to be reported.
Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose
Apparent Volume of Distribution (Vz/F) of Maribavir for Adolescent Participants
Apparent volume of distribution (Vz/F) of maribavir for adolescent participants was planned to be reported.
Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose
Tucson
Arizona
85724
United States
City of Hope National Medical Center
Duarte
California
91010
United States
University of Southern California
Los Angeles
California
90033
United States
UCLA Medical Center
Los Angeles
California
90095
United States
UC Davis Medical Center
Sacramento
California
95817
United States
Stanford University
Stanford
California
94305
United States
Yale University School of Medicine
New Haven
Connecticut
06520
United States
AdventHealth
Orlando
Florida
32804
United States
Emory University Hospital
Atlanta
Georgia
30322
United States
Feinberg School of Medicine Northwestern University
Chicago
Illinois
60611
United States
Loyola University Medical Center
Maywood
Illinois
60153
United States
University of Chicago Medical Center
Maywood
Illinois
60153
United States
University of Kentucky
Lexington
Kentucky
40536
United States
Ochsner Clinic Foundation
New Orleans
Louisiana
70121
United States
University of Maryland
Baltimore
Maryland
21201
United States
Johns Hopkins Hospital
Baltimore
Maryland
21287
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Brigham and Womens Hospital
Boston
Massachusetts
02115
United States
UMass Memorial Medical Center
Worcester
Massachusetts
01655
United States
University of Michigan
Ann Arbor
Michigan
48109
United States
Henry Ford Health System
Detroit
Michigan
48202
United States
William Beaumont Hospital
Royal Oak
Michigan
48073
United States
University of Minnesota
Minneapolis
Minnesota
55454
United States
Mayo Clinic - PPDS
Rochester
Minnesota
59905
United States
University of Nebraska Medical Center
Omaha
Nebraska
68198-5400
United States
Hackensack University Medical Center
Hackensack
New Jersey
07601
United States
Columbia University Medical Center
New York
New York
10032
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
New York Presbyterian Hospital - Weill-Cornell
New York
New York
10065
United States
SUNY Upstate Medical Center
Syracuse
New York
13210
United States
Duke University Medical Center
Durham
North Carolina
27710-4000
United States
The Christ Hospital
Cincinnati
Ohio
45220
United States
University of Cincinnati
Cincinnati
Ohio
45220
United States
Cincinnati Children's Hospital Medical Center - PIN
Cincinnati
Ohio
45229-3039
United States
University Hospitals Cleveland Medical Center
Cleveland
Ohio
44106
United States
Nationwide Children's Hospital
Columbus
Ohio
43205
United States
University of Pennsylvania
Philadelphia
Pennsylvania
19104
United States
University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
15213
United States
Medical University of South Carolina - PPDS
Charleston
South Carolina
29425
United States
St Jude Children's Research Hospital
Memphis
Tennessee
38105
United States
University of Texas Southwestern Medical Center
Dallas
Texas
75390
United States
Baylor All Saints Medical Center
Fort Worth
Texas
76104
United States
Baylor College of Medicine
Houston
Texas
77030-2348
United States
MD Anderson Cancer Center
Houston
Texas
77030
United States
University of Utah Health Sciences Center - PPDS
Salt Lake City
Utah
84132
United States
Fred Hutchinson Cancer Research Center
Seattle
Washington
98109
United States
Westmead Hospital
Westmead
New South Wales
2145
Australia
Monash Health, Monash Medical Centre
Clayton
Victoria
3168
Australia
The Alfred Hospital
Melbourne
Victoria
3004
Australia
Royal Melbourne Hospital
Parkville
Victoria
3050
Australia
Sir Charles Gairdner Hospital
Nedlands
Washington
6009
Australia
Princess Alexandra Hospital
Brisbane
4102
Australia
Tiroler Landeskrankenanstalten GmbH
Innsbruck
6020
Austria
Allgemeines Krankenhaus der Stadt Wien
Vienna
1090
Austria
UZ Antwerpen
Edegem
Antwerpen
2650
Belgium
Institut Jules Bordet
Brussels
Brussels Capital
1000
Belgium
UZ Gent
Ghent
Oost-Vlaanderen
9000
Belgium
UZ Leuven
Leuven
Vlaams Brabant
3000
Belgium
AZ Sint-Jan AV
Bruges
West-Vlaanderen
8000
Belgium
ZNA Stuivenberg
Antwerp
2060
Belgium
Hôpital Erasme
Brussels
1070
Belgium
UZ Brussel
Brussels
1090
Belgium
University of Alberta
Edmonton
Alberta
T6G 2G3
Canada
Hamilton Health Sciences Corporation
Hamilton
Ontario
L8N 3Z5
Canada
St. Joseph's Healthcare Hamilton
Hamilton
Ontario
L8N 4A6
Canada
Princess Margaret Hospital
Toronto
Ontario
M5G 2M9
Canada
University Health Network
Toronto
Ontario
M5G 2N2
Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal
Quebec
H3T 1C5
Canada
McGill University Health Center
Montreal
Quebec
H4A 3J1
Canada
University Hospital Center Zagreb
Zagreb
10000
Croatia
Copenhagen University Hospital
København Ø
Capital
2100
Denmark
CHRU Brest - Hospital Cavale Blanche
Brest
Finistère
29609
France
Hôpital de Rangueil
Toulouse
Haute-Garonne
31059
France
Hopital Foch
Suresnes
Hauts-de-Seine
92150
France
CHRU Rennes
Rennes
Ille-et-Vilaine
35033
France
CHRU Bretonneau
Tours
Indre-et-Loire
37044
France
CHRU Nantes
Nantes
Loire-Atlantique
44093
France
Hôpital de La Croix Rousse
Lyon
Rhône
69004
France
Centre Hospitalier Lyon Sud
Pierre-Bénite
Rhône
69495
France
Hopital Henri Mondor
Créteil
Val-de-Marne
94010
France
Hôpital Paul Brousse
Villejuif
Val-de-Marne
94800
France
CHU Amiens Hôpital Sud
Amiens
80054
France
Hopital Gabriel Montpied
Clermont-Ferrand
63003
France
CHU de GRENOBLE
Grenoble
38043
France
CHRU Lille
Lille
59037
France
CHU Dupuytren
Limoges
87042
France
Groupement Hospitalier Edouard Herriot
Lyon
69437
France
Groupe Hospitalier Necker Enfants Malades
Paris
75015
France
Hôpital Saint Louis
Paris
75475
France
Hôpital Saint Antoine
Paris
75571
France
CHRU de Poitiers La Miletrie
Poitiers
86000
France
Institut de Cancerologie de la Loire
Saint-Priest-en-Jarez
42271
France
Hopital de Hautepierre
Strasbourg
67091
France
Hôpital Civil
Strasbourg
67091
France
University Clinic Heidelberg - PPDS
Heidelberg
Baden-Wurttemberg
69120
Germany
Universitätsklinikum Erlangen
Erlangen
Bavaria
91054
Germany
Universitätsklinikum Essen
Essen
North Rhine-Westphalia
45122
Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz
Rhineland-Palatinate
55101
Germany
Universitatsklinikum Leipzig
Leipzig
Saxony
04103
Germany
Universitätsklinikum Erlangen
Erlangen
91054
Germany
University Clinic Heidelberg - PPDS
Heidelberg
69120
Germany
LMU Klinikum der Universität München
München
81377
Germany
Universitätsklinikum Tübingen
Tübingen
72076
Germany
Ospedale San Raffaele S.r.l. - PPDS
Milan
Lombardy
20132
Italy
Istituto Europeo Di Oncologia
Milan
Lombardy
20141
Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
Ancona
The Marches
60126
Italy
Azienda Ospedaliero Universitaria di Parma
Parma
43126
Italy
Azienda Ospedaliero Universitaria Pisana
Pisa
56216
Italy
Fondazione Policlinico Universitario A Gemelli
Roma
00168
Italy
Azienda Sanitaria Universitaria Integrata di Udine
Udine
12345
Italy
Singapore General Hospital (SGH)
Singapore
169608
Singapore
Hospital Universitario Germans Trias i Pujol
Badalona
Barcelona
08916
Spain
Hospital Universitario de Cruces
Barakaldo
48903
Spain
Fundacio Puigvert
Barcelona
08025
Spain
Hospital Universitario Vall d'Hebrón - PPDS
Barcelona
08035
Spain
Hospital de La Santa Creu i Sant Pau
Barcelona
08041
Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat
08907
Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Madrid
28222
Spain
Complejo Asistencial Universitario de Salamanca - H. Clinico
Salamanca
37007
Spain
Hospital Clinico Universitario de Valencia
Valencia
46010
Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia
46026
Spain
Centre Hospitalier Universitaire Vaudois
Lausanne
Vaud (fr)
1011
Switzerland
University Hospital Coventry
Coventry
Birmingham
CV2 2DX
United Kingdom
Birmingham Heartlands Hospital
West Midlands
Birmingham
B9 5SS
United Kingdom
Beatson West of Scotland Cancer Centre - PPDS
Glasgow
Glasgow City
G12 0YN
United Kingdom
Imperial College Healthcare NHS Trust
London
London, City of
W12 0HS
United Kingdom
Wythenshawe Hospital - PPDS
Wythenshawe
Manchester
M23 9LT
United Kingdom
Sheffield Childrens Hospital
Sheffield
Yorkshire
S10 2TH
United Kingdom
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool
L7 8XP
United Kingdom
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
London
NW3 2QG
United Kingdom
Royal Free Hospital
London
NW3 2QG
United Kingdom
Manchester Royal Infirmary - PPDS
Manchester
M13 9WL
United Kingdom
Churchill Hospital
Oxford
OX3 7LJ
United Kingdom
Rajagopalan K, Bullano M, Gelone D, Bo T, Taduka V, Syed SS. Real-world effectiveness and tolerability of post solid organ transplant patients with CMV switching from valganciclovir treatment to maribavir: analysis using lab-linked claims data in the United States. Expert Rev Anti Infect Ther. 2025 Aug;23(8):653-662. doi: 10.1080/14787210.2025.2517344. Epub 2025 Jun 27.
Blumberg EA, Witzke O, Harber M, Ison MG, Saliba F, Kamar N, Sundberg AK, Gu J, Kumar D, La Hoz RM. Maribavir for refractory cytomegalovirus infection (with or without resistance) in solid organ transplant recipients: Subgroup analysis of the phase 3 randomized SOLSTICE study. J Heart Lung Transplant. 2025 Jun;44(6):986-994. doi: 10.1016/j.healun.2024.11.026. Epub 2024 Nov 28.
Sun K, Fournier M, Sundberg AK, Song IH. Maribavir: Mechanism of action, clinical, and translational science. Clin Transl Sci. 2024 Jan;17(1):e13696. doi: 10.1111/cts.13696.
Del Pozo Martin Y. 47th Annual Meeting of the EBMT. Lancet Haematol. 2021 May;8(5):e317-e318. doi: 10.1016/S2352-3026(21)00104-6. Epub 2021 Mar 31. No abstract available.
Participants received maribavir 400 milligram (mg) (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
FG002
Maribavir Rescue Arm
Participants with clear evidence of virologic failure (not just intolerance) after a minimum of 3 weeks of therapy with IAT entered maribavir rescue arm and received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
FG000117 subjects
FG001235 subjects
FG0020 subjects
Treated Participants
FG000116 subjects
FG001234 subjects
FG0020 subjects
IAT (Ganciclovir/ Valganciclovir)
FG00056 subjects
FG0010 subjects
FG0020 subjects
IAT (Foscarnet)
FG00047 subjects
FG0010 subjects
FG0020 subjects
IAT (Cidofovir)
FG0006 subjects
FG0010 subjects
FG0020 subjects
IAT (Foscarnet + Valganciclovir/Ganciclovir)
FG0007 subjects
FG0010 subjects
FG0020 subjects
COMPLETED
FG00058 subjects
FG001199 subjects
FG0020 subjects
NOT COMPLETED
FG00059 subjects
FG00136 subjects
FG0020 subjects
Type
Comment
Reasons
Investigator discretion
FG0001 subjects
FG0011 subjects
FG0020 subjects
Adverse Event
FG0005 subjects
FG0011 subjects
FG0020 subjects
Lost to Follow-up
FG0001 subjects
FG0012 subjects
FG0020 subjects
Death
FG0008 subjects
FG00124 subjects
FG0020 subjects
Withdrawal by Subject
FG00016 subjects
FG0018 subjects
FG0020 subjects
Protocol Violation
FG0006 subjects
FG0010 subjects
FG0020 subjects
Participants transitioned into maribavir rescue arm
FG00022 subjects
FG0010 subjects
FG0020 subjects
Period 2: Maribavir Rescue Therapy
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG00222 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG00220 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0022 subjects
Type
Comment
Reasons
Sponsor decision
FG0000 subjects
FG0010 subjects
FG0022 subjects
The randomized set consisted of all participants who had signed an informed consent and had begun some study procedures, and randomized to the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Investigator-assigned Anti-CMV Treatment (IAT)
Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
BG001
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000117
BG001235
BG002352
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
BG00051.5± 12.80
BG00153.8± 13.39
BG00253.0± 13.22
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00052
BG00187
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0007
BG00114
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) (CMV Viremia Clearance) at End of Week 8
Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration less than (<) lower limit of quantification (LLOQ) that is, <137 International Units per milliliter (IU/mL) when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive postbaseline samples, separated by at least 5 days. Percentage of participants with confirmed CMV viremia clearance at end of study Week 8 regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy, and could not have received alternative anti-CMV treatment were reported.
The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study.
Posted
Number
percentage of participants
Week 8
ID
Title
Description
OG000
Investigator-assigned Anti-CMV Treatment (IAT)
Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
OG001
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Units
Counts
Participants
OG000117
OG001235
Title
Denominators
Categories
Title
Measurements
OG00023.9
OG00155.7
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
OG001
Cochran-Mantel-Haenszel
<0.001
Difference in percentage of responders
32.8
2-Sided
95
22.80
42.74
Superiority
Secondary
Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at End of Week 8, Followed by Maintenance of Treatment Effect at Week 16
Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration \
The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study.
Posted
Number
percentage of participants
Up to Week 16
ID
Title
Description
OG000
Investigator-assigned Anti-CMV Treatment (IAT)
Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
OG001
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Secondary
Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment
Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration \
The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study.
Posted
Number
percentage of participants
At Week 8 through Weeks 12, 16 and 20
ID
Title
Description
OG000
Investigator-assigned Anti-CMV Treatment (IAT)
Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
OG001
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Secondary
Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control After Receiving 8 Weeks of Study-assigned Treatment Through Weeks 12, 16 and 20
Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration \
The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study.
Posted
Number
percentage of participants
At Week 8 through Weeks 12, 16 and 20
ID
Title
Description
OG000
Investigator-assigned Anti-CMV Treatment (IAT)
Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
OG001
Maribavir 400 mg
Secondary
Percentage of Participants Who Maintained CMV Viremia Clearance and CMV Infection Symptom Control at the End of Study Week 8 Through Weeks 12 and 20 Regardless of Whether Either Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy
Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration \
The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study.
Posted
Number
percentage of participants
At Week 8 through Weeks 12 and 20
ID
Title
Description
OG000
Investigator-assigned Anti-CMV Treatment (IAT)
Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
OG001
Maribavir 400 mg
Secondary
Percentage of Participants With Recurrence of CMV Viremia During the First 8 Weeks of Study Regardless of Whether Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy
Recurrence of CMV viremia was defined as plasma CMV DNA concentration greater than or equal to (>=) LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy. Percentage of participants with recurrence of CMV viremia during the first 8 weeks of study regardless of whether study-assigned treatment was discontinued before 8 weeks of therapy were reported.
The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study.
Posted
Number
percentage of participants
At Week 8
ID
Title
Description
OG000
Investigator-assigned Anti-CMV Treatment (IAT)
Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
OG001
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Secondary
Percentage of Participants With Recurrence of CMV Viremia During the 12 Weeks Follow-up Period Regardless of Whether Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy
Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy. Percentage of participants with recurrence of CMV viremia during the 12 weeks follow-up period regardless of whether study-assigned treatment was discontinued before 8 weeks of therapy were reported.
The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study.
Posted
Number
percentage of participants
End of Week 8 up to Week 20 (12 weeks follow-up period)
ID
Title
Description
OG000
Investigator-assigned Anti-CMV Treatment (IAT)
Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
OG001
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Secondary
Percentage of Participants With Recurrence of CMV Viremia at Any Time on Study Regardless of Whether Study-assigned Treatment Was Discontinued Before 8 Weeks of Therapy
Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy. Percentage of participants with recurrence of CMV viremia during at any time on study regardless of whether study-assigned treatment was discontinued before 8 weeks of therapy were reported.
The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study.
Posted
Number
percentage of participants
Baseline up to Week 20
ID
Title
Description
OG000
Investigator-assigned Anti-CMV Treatment (IAT)
Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
OG001
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Secondary
Percentage of Participants Who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the First 8 Weeks of the Treatment
Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants with recurrence of CMV viremia during the first 8 Weeks of the treatment who completed 8 weeks of study-assigned treatment were reported.
The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure.
Posted
Number
percentage of participants
Baseline up to Week 8
ID
Title
Description
OG000
Investigator-assigned Anti-CMV Treatment (IAT)
Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
OG001
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Secondary
Percentage of Participants Who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the 12 Weeks of Follow-up Period
Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants who completed 8 weeks of study-assigned treatment with recurrence of CMV viremia during the 12 weeks of follow-up period were reported.
The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure.
Posted
Number
percentage of participants
End of Week 8 up to Week 20 (12 weeks follow-up period)
ID
Title
Description
OG000
Investigator-assigned Anti-CMV Treatment (IAT)
Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
OG001
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Secondary
Percentage of Participants Who Completed 8 Weeks of Study-assigned Treatment With Recurrence of CMV Viremia During the 20 Weeks of Study
Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants with Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants who completed 8 weeks of study-assigned treatment with recurrence of CMV viremia during the 20 weeks of study were reported.
The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure.
Posted
Number
percentage of participants
Baseline up to Week 20
ID
Title
Description
OG000
Investigator-assigned Anti-CMV Treatment (IAT)
Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
OG001
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Secondary
Percentage of Participants With Recurrence of CMV Viremia While on Study-assigned Treatment
Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants with recurrence of CMV viremia while on study-assigned treatment period were reported.
The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study.
Posted
Number
percentage of participants
Baseline up to termination of study treatment (up to Week 8)
ID
Title
Description
OG000
Investigator-assigned Anti-CMV Treatment (IAT)
Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
OG001
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Units
Counts
Secondary
Percentage of Participants With Recurrence of CMV Viremia While Off Study-assigned Treatment During Follow-up Period
Recurrence of CMV viremia was defined as plasma CMV DNA concentration >=LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants with recurrence of CMV viremia while off study-assigned treatment during follow-up period were reported.
The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study.
Posted
Number
percentage of participants
Termination of study treatment (Week 8) up to the End of the Study (Week 20)
ID
Title
Description
OG000
Investigator-assigned Anti-CMV Treatment (IAT)
Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
OG001
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Units
Counts
Secondary
Number of Participants Who Had Maribavir CMV Resistance at Baseline
Resistance-associated amino acid substitutions (RASs) to maribavir are known to generally map to the pUL97 and pUL27 genes. Genotyping was performed to identify RASs mapping to the pUL97 and pUL27 genes. Number of participants who had maribavir CMV resistance at baseline were reported.
The combination of maribavir resistance set (MRS) and non-MRS set (MRS+non-MRS) included all participants in modified randomized set who had been randomized in the study and who had taken any dose of study-assigned treatment with evaluable CMV genotypic data at baseline with or without pre-existing known maribavir RASs in pUL97 and/or pUL27. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure.
Posted
Count of Participants
Participants
No
At Baseline
ID
Title
Description
OG000
Investigator-assigned Anti-CMV Treatment (IAT)
Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
OG001
Maribavir Rescue Arm
Participants with clear evidence of virologic failure (not just intolerance) after a minimum of 3 weeks of therapy with IAT entered maribavir rescue arm and received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Secondary
Number of Participants Who Had Post-baseline Resistance to Maribavir
Resistance-associated amino acid substitutions (RASs) to maribavir are known to generally map to the pUL97 and pUL27 genes. Genotyping was performed to identify RASs mapping to the pUL97 and pUL27 genes. Number of participants who had post-baseline resistance to maribavir were reported.
The combination of maribavir resistance set (MRS) and non-MRS set (MRS+non-MRS) included all participants in modified randomized set who had been randomized in the study and who had taken any dose of study-assigned treatment with evaluable CMV genotypic data at baseline with or without pre-existing known maribavir RASs in pUL97 and/or pUL27.
Posted
Count of Participants
Participants
No
After first dose of study drug up to Week 20
ID
Title
Description
OG000
Investigator-assigned Anti-CMV Treatment (IAT)
Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
OG001
Maribavir Rescue Arm
Participants with clear evidence of virologic failure (not just intolerance) after a minimum of 3 weeks of therapy with IAT entered maribavir rescue arm and received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Secondary
Number of Participants With All-cause Mortality by the End of the Study
All-cause mortality was analyzed by the end of study regardless of the use of rescue treatment or alternative anti-CMV treatment. Number of participants who died during the entire study period were reported.
The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study.
Posted
Count of Participants
Participants
From enrollment up to end of study (approximately 44 months)
ID
Title
Description
OG000
Investigator-assigned Anti-CMV Treatment (IAT)
Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
OG001
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Units
Counts
Participants
Secondary
Time to All Cause Mortality
The time to all-cause mortality by the end of the study participation in days was calculated. Participants who were alive at the last study follow-up (regardless of use of rescue or alternative anti-CMV treatment), withdrew from study or were lost to follow-up were censored at the date of last contact.
The randomized set consisted of all participants who had signed informed consent and had begun some study procedures and were randomized to the study.
Posted
Median
Full Range
days
From enrollment to last serious adverse event (SAE) follow-up (approximately Week 28)
ID
Title
Description
OG000
Investigator-assigned Anti-CMV Treatment (IAT)
Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
OG001
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Units
Counts
Participants
Secondary
Percentage of Participants Who Achieved Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at End of Week 8 After Starting Maribavir Rescue Treatment
Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration \
The rescue set consisted of all participants who entered the rescue arm and received any dose of maribavir as rescue therapy. As planned, this OM was assessed only in maribavir rescue arm.
Posted
Number
95% Confidence Interval
percentage of participants
From start of maribavir rescue treatment through 8 weeks
ID
Title
Description
OG000
Maribavir Rescue Arm
Participants with clear evidence of virologic failure (not just intolerance) after a minimum of 3 weeks of therapy with IAT entered maribavir rescue arm and received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Units
Counts
Participants
Secondary
Percentage of Participants Receiving Maribavir Rescue Treatment Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at Week 8 With Maintenance of Effect Through Week 16
Confirmed CMV viremia clearance was defined as plasma CMV DNA concentration \
The rescue set consisted of all participants who entered the rescue arm and received any dose of maribavir as rescue therapy. As planned, this OM was assessed only in maribavir rescue arm.
Posted
Number
95% Confidence Interval
percentage of participants
Up to Week 16
ID
Title
Description
OG000
Maribavir Rescue Arm
Participants with clear evidence of virologic failure (not just intolerance) after a minimum of 3 weeks of therapy with IAT entered maribavir rescue arm and received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs During the On-treatment Observation Period
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Serious AE was any untoward medical occurrence (whether considered to be related to study-assigned treatment or not) that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital abnormality/birth defect, or was an important medical event. TEAEs was defined as any adverse events (classified by preferred term) that had a start date on or after the first dose of study treatment or that had a start date before the date of first dose of study treatment, but increased in severity after the first dose of study treatment.
The safety set consisted of all participants who had taken any dose of study treatment.
Posted
Count of Participants
Participants
No
Baseline up to 7 days or 21 days (if cidofovir used) after the last dose of study treatment (up to Week 8)
ID
Title
Description
OG000
Investigator-assigned Anti-CMV Treatment (IAT)
Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion Participants received 1 or 2 of the 4 anti-CMV agents from the following: ganciclovir, valganciclovir, foscarnet, or cidofovir based on the investigator's discretion for the 8 week treatment period.
Secondary
Predose Concentration (Cmin) of Maribavir
Cmin of maribavir was reported.
The pharmacokinetic set consisted of all participants who had taken any dose of study treatment and who had plasma samples drawn and tested for maribavir concentrations. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure and "number analyzed" were participants who were evaluable for the outcome measure at given time points.
Posted
Mean
Standard Deviation
micrograms per milliliter (mcg/mL)
Predose at Week 1, 4 and 8
ID
Title
Description
OG000
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
OG001
Maribavir Rescue Arm
Participants with clear evidence of virologic failure (not just intolerance) after a minimum of 3 weeks of therapy with IAT entered maribavir rescue arm and received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Units
Counts
Participants
Secondary
Area Under the Concentration Time Curve Over the 12-hour Dosing Interval at Steady State (AUC0-tau) of Marivabir for Adolescent Participants
AUC0-tau of maribavir for adolescent participants was planned to be reported.
The pharmacokinetic set consisted of all participants who had taken any dose of study treatment and who had plasma samples drawn and tested for maribavir concentrations. This OM was planned to be analyzed only in adolescent participants. Data was not collected and analyzed as adolescent participants were not enrolled in this study. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure.
Posted
Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose, Week 4: Pre-morning dose, and Week 8: Pre-morning dose and 2-4 hour post morning dose
ID
Title
Description
OG000
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
OG001
Maribavir Rescue Arm
Participants with clear evidence of virologic failure (not just intolerance) after a minimum of 3 weeks of therapy with IAT entered maribavir rescue arm and received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Secondary
Maximum Plasma Concentration (Cmax) of Maribavir for Adolescent Participants
Cmax of maribavir for adolescent participants was planned to be reported.
The pharmacokinetic set consisted of all participants who had taken any dose of study treatment and who had plasma samples drawn and tested for maribavir concentrations. This OM was planned to be analyzed only in adolescent participants. Data was not collected and analyzed as adolescent participants were not enrolled in this study. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure.
Posted
Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose
ID
Title
Description
OG000
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
OG001
Maribavir Rescue Arm
Participants with clear evidence of virologic failure (not just intolerance) after a minimum of 3 weeks of therapy with IAT entered maribavir rescue arm and received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Units
Counts
Secondary
Time When Maximum Concentration is Observed (Tmax) of Maribavir for Adolescent Participants
Tmax of maribavir for adolescent participants was planned to be reported.
The pharmacokinetic set consisted of all participants who had taken any dose of study treatment and who had plasma samples drawn and tested for maribavir concentrations. This OM was planned to be analyzed only in adolescent participants. Data was not collected and analyzed as adolescent participants were not enrolled in this study. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure.
Posted
Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose
ID
Title
Description
OG000
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
OG001
Maribavir Rescue Arm
Participants with clear evidence of virologic failure (not just intolerance) after a minimum of 3 weeks of therapy with IAT entered maribavir rescue arm and received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Units
Counts
Secondary
Apparent Oral Clearance (CL/F) of Maribavir for Adolescent Participants
Apparent oral clearance (CL/F) of maribavir for adolescent participants was planned to be reported.
The pharmacokinetic set consisted of all participants who had taken any dose of study treatment and who had plasma samples drawn and tested for maribavir concentrations. This OM was planned to be analyzed only in adolescent participants. Data was not collected and analyzed as adolescent participants were not enrolled in this study. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure.
Posted
Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose
ID
Title
Description
OG000
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
OG001
Maribavir Rescue Arm
Participants with clear evidence of virologic failure (not just intolerance) after a minimum of 3 weeks of therapy with IAT entered maribavir rescue arm and received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Units
Counts
Secondary
Apparent Volume of Distribution (Vz/F) of Maribavir for Adolescent Participants
Apparent volume of distribution (Vz/F) of maribavir for adolescent participants was planned to be reported.
The pharmacokinetic set consisted of all participants who had taken any dose of study treatment and who had plasma samples drawn and tested for maribavir concentrations. This OM was planned to be analyzed only in adolescent participants. Data was not collected and analyzed as adolescent participants were not enrolled in this study. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure.
Posted
Week 1: Pre-morning dose and 1, 2, 3, 4, 6, 8 and 12 hours post morning dose
ID
Title
Description
OG000
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
OG001
Maribavir Rescue Arm
Participants with clear evidence of virologic failure (not just intolerance) after a minimum of 3 weeks of therapy with IAT entered maribavir rescue arm and received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Units
Counts
Time Frame
Baseline up to end of study (approximately 44 months)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
IAT: Ganciclovir/ Valganciclovir
Participants received ganciclovir intravenously or valganciclovir orally based on the the investigator's discretion for the 8 week treatment period.
6
56
33
56
54
56
EG001
IAT: Foscarnet
Participants received foscarnet intravenously based on investigator's discretion for the 8 week treatment period.
7
47
26
47
43
47
EG002
IAT: Cidofovir
Participants received cidofovir intravenously based on the investigator's discretion for the 8 week treatment period.
0
6
3
6
5
6
EG003
IAT: Foscarnet + Ganciclovir/ Valganciclovir
Participants received foscarnet intravenously in combination with ganciclovir intravenously or valganciclovir orally based on investigator's discretion for the 8 week treatment period.
0
7
1
7
7
7
EG004
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
27
234
131
234
229
234
EG005
Maribavir Rescue Arm
Participants with clear evidence of virologic failure (not just intolerance) after a minimum of 3 weeks of therapy with IAT entered maribavir rescue arm and received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
0
22
14
22
22
22
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected7 at risk
EG0044 events4 affected234 at risk
EG0052 events2 affected22 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG0004 events4 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG0003 events3 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Sickle cell anaemia with crisis
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Thrombotic microangiopathy
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0012 events2 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Adverse drug reaction
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Disease progression
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Drug interaction
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
General physical health deterioration
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Malaise
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0012 events2 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Treatment failure
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Acute graft versus host disease
Immune system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Graft versus host disease in gastrointestinal tract
Immune system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Graft versus host disease in liver
Immune system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Transplant rejection
Immune system disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Aspergillus infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
BK virus infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Bacterial pyelonephritis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Bronchopulmonary aspergillosis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cytomegalovirus chorioretinitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cytomegalovirus colitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cytomegalovirus infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0003 events3 affected56 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Cytomegalovirus infection reactivation
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cytomegalovirus mucocutaneous ulcer
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cytomegalovirus syndrome
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cytomegalovirus viraemia
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0003 events3 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Device related infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Device related sepsis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Encephalitis cytomegalovirus
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Encephalitis viral
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Enterococcal bacteraemia
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Escherichia sepsis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Gastroenteritis rotavirus
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
H1N1 influenza
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Herpes zoster meningoencephalitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Periorbital cellulitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia cryptococcal
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia cytomegaloviral
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia haemophilus
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pseudomonal sepsis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Septic shock
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Streptococcal bacteraemia
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Varicella zoster virus infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Incorrect dose administered
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Procedural pneumothorax
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Transplant dysfunction
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
General physical condition abnormal
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Immunosuppressant drug level increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Viral load increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Weight decreased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Acute lymphocytic leukaemia recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Acute myeloid leukaemia recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Leukaemia recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Substance-induced psychotic disorder
Psychiatric disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0016 events6 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0012 events2 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pneumomediastinum
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Febrile bone marrow aplasia
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Immune thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Glaucoma
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Iridocyclitis
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Gastrointestinal angiodysplasia
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Ileal perforation
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Graft versus host disease
Immune system disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Renal transplant failure
Immune system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Adenovirus infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Atypical pneumonia
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Campylobacter gastroenteritis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cerebral toxoplasmosis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Clostridium colitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Coronavirus infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cytomegalovirus enterocolitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cytomegalovirus gastroenteritis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cytomegalovirus gastrointestinal infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Febrile infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia respiratory syncytial viral
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Salmonellosis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Septic arthritis staphylococcal
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Sinusitis fungal
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Staphylococcal osteomyelitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Stenotrophomonas infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Transplant failure
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Acidosis hyperchloraemic
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Intervertebral disc compression
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Diffuse large B-cell lymphoma recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Post transplant lymphoproliferative disorder
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Guillain-Barre syndrome
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Device breakage
Product Issues
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Depression
Psychiatric disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Nephrotic syndrome
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Renal artery stenosis
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Venous thrombosis
Vascular disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Vesicoureteric reflux
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG0008 events7 affected56 at risk
EG00112 events10 affected47 at risk
EG0022 events1 affected6 at risk
EG0031 events1 affected7 at risk
EG00436 events31 affected234 at risk
EG0053 events3 affected22 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG0008 events7 affected56 at risk
EG0012 events2 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG00041 events19 affected56 at risk
EG00117 events8 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG0008 events7 affected56 at risk
EG0012 events2 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0004 events4 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0008 events6 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0007 events7 affected56 at risk
EG0013 events2 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG00018 events16 affected56 at risk
EG00115 events10 affected47 at risk
EG0022 events1 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG00017 events12 affected56 at risk
EG00119 events16 affected47 at risk
EG0022 events2 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG00016 events13 affected56 at risk
EG00110 events9 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Non-systematic Assessment
EG00010 events10 affected56 at risk
EG0015 events5 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0007 events5 affected56 at risk
EG00110 events7 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Non-systematic Assessment
EG00015 events12 affected56 at risk
EG00111 events10 affected47 at risk
EG0022 events2 affected6 at risk
EG003
Cytomegalovirus viraemia
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0005 events5 affected56 at risk
EG0013 events3 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0004 events4 affected56 at risk
EG0015 events4 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Immunosuppressant drug level increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0007 events7 affected56 at risk
EG0014 events4 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0004 events3 affected56 at risk
EG00112 events8 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0007 events5 affected56 at risk
EG00110 events9 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0003 events3 affected56 at risk
EG0013 events3 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0006 events6 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0007 events7 affected56 at risk
EG0012 events2 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0004 events4 affected56 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG00011 events9 affected56 at risk
EG00110 events9 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0003 events3 affected56 at risk
EG0019 events7 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0007 events7 affected56 at risk
EG0014 events4 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0005 events4 affected56 at risk
EG0014 events4 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected56 at risk
EG0017 events6 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cataract
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Chorioretinopathy
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Dry eye
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pterygium
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Vision blurred
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0012 events2 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Chills
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0011 events1 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Gait disturbance
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Temperature intolerance
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
BK virus infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0012 events2 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cytomegalovirus infection reactivation
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0005 events4 affected56 at risk
EG0012 events2 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0004 events4 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0004 events4 affected56 at risk
EG0014 events4 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Blood calcium decreased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Clostridium test positive
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Liver function test increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Platelet count decreased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0005 events4 affected56 at risk
EG0014 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected56 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected56 at risk
EG0015 events5 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0003 events3 affected56 at risk
EG00110 events6 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0013 events3 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0012 events2 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Aura
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0016 events5 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Peroneal nerve palsy
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected56 at risk
EG0013 events3 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected56 at risk
EG0014 events4 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0013 events3 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0011 events1 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0014 events3 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0005 events5 affected56 at risk
EG0013 events3 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.0
Non-systematic Assessment
EG0004 events4 affected56 at risk
EG0012 events2 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Ear congestion
Ear and labyrinth disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Thyroiditis
Endocrine disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0012 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Appendix disorder
Gastrointestinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0003 events3 affected56 at risk
EG0013 events3 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Device related thrombosis
General disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Graft versus host disease
Immune system disorders
MedDRA 23.0
Non-systematic Assessment
EG0003 events1 affected56 at risk
EG0013 events3 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Graft versus host disease in gastrointestinal tract
Immune system disorders
MedDRA 23.0
Non-systematic Assessment
EG0003 events3 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Transplant rejection
Immune system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0013 events3 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Cytomegalovirus infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0003 events3 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0003 events3 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0012 events2 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Systemic bacterial infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Varicella zoster virus infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Non-systematic Assessment
EG0004 events3 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0003 events3 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0003 events3 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Blood urea increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Transaminases increased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected56 at risk
EG0013 events3 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Weight decreased
Investigations
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected56 at risk
EG0011 events1 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0001 events1 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Non-systematic Assessment
EG0003 events3 affected56 at risk
EG0013 events2 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected56 at risk
EG0012 events2 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Tremor
Nervous system disorders
MedDRA 23.0
Non-systematic Assessment
EG0004 events4 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Tonsillar hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Non-systematic Assessment
EG0000 events0 affected56 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected6 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA 23.0
Non-systematic Assessment
EG0002 events2 affected56 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Units
Counts
Participants
OG000117
OG001235
Title
Denominators
Categories
At Week 8
Title
Measurements
OG00018.8
OG00154.9
At Week 12
Title
Measurements
OG0005.1
OG00122.6
At Week 16
Title
Measurements
OG0005.1
OG00118.7
At Week 20
Title
Measurements
OG0004.3
OG00118.3
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Units
Counts
Participants
OG000117
OG001235
Title
Denominators
Categories
At Week 8
Title
Measurements
OG00023.9
OG00155.7
At Week 12
Title
Measurements
OG00010.3
OG00122.6
At Week 20
Title
Measurements
OG0009.4
OG00118.3
Units
Counts
Participants
OG000117
OG001235
Title
Denominators
Categories
Title
Measurements
OG00012.3
OG00117.9
Units
Counts
Participants
OG000117
OG001235
Title
Denominators
Categories
Title
Measurements
OG00021.5
OG00138.6
Units
Counts
Participants
OG000117
OG001235
Title
Denominators
Categories
Title
Measurements
OG00033.8
OG00156.5
Units
Counts
Participants
OG00037
OG001183
Title
Denominators
Categories
Title
Measurements
OG0009.7
OG00115.2
Units
Counts
Participants
OG00037
OG001183
Title
Denominators
Categories
Title
Measurements
OG00035.5
OG00140.9
Units
Counts
Participants
OG00037
OG001183
Title
Denominators
Categories
Title
Measurements
OG00045.2
OG00156.1
Participants
OG000117
OG001235
Title
Denominators
Categories
Title
Measurements
OG0004.6
OG00115.8
Participants
OG000117
OG001235
Title
Denominators
Categories
Title
Measurements
OG00029.2
OG00140.8
OG002
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Units
Counts
Participants
OG000100
OG00117
OG002214
Title
Denominators
Categories
RASs associated with pUL97 only
Title
Measurements
OG0003
OG0011
OG0020
RASs associated with pUL27 only
Title
Measurements
OG0000
OG0010
OG0021
RASs associated with pUL97 and pUL27
Title
Measurements
OG0000
OG0010
OG0020
OG002
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
Units
Counts
Participants
OG000100
OG00117
OG002214
Title
Denominators
Categories
RASs associated with pUL97 only
Title
Measurements
OG0000
OG0014
OG00245
RASs associated with pUL27 only
Title
Measurements
OG0000
OG0010
OG0020
RASs associated with pUL97 and pUL27
Title
Measurements
OG0000
OG0010
OG0020
OG000117
OG001235
Title
Denominators
Categories
Title
Measurements
OG00013
OG00127
OG000117
OG001235
Title
Denominators
Categories
Title
Measurements
OG00073.0(13.0 to 186.0)
OG00155.0(3.0 to 182.0)
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
OG001
Log Rank
Two-sided p-value comparing treatment groups was calculated from the log rank test by Kaplan-Meier Method.
0.647
Hazard Ratio (HR)
1.14
2-Sided
95
0.549
2.357
Stratified Cox regression model was used as transplant type and baseline plasma CMV DNA level as stratification factors.
Other
OG00022
Title
Denominators
Categories
Title
Measurements
OG00050.0(28.22 to 71.78)
Units
Counts
Participants
OG00022
Title
Denominators
Categories
Title
Measurements
OG00027.3(10.73 to 50.22)
OG001
Maribavir Rescue Arm
Participants with clear evidence of virologic failure (not just intolerance) after a minimum of 3 weeks of therapy with IAT entered maribavir rescue arm and received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.
OG002
Maribavir 400 mg
Participants received maribavir 400 mg (2*200 mg tablets), orally, twice daily for the 8 week treatment period.