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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8228-045 | Other Identifier | MSD |
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The purpose of this study is to evaluate the efficacy and safety of a once-a-day oral or intravenous (IV) dose of Letermovir (MK-8228) in Chinese adult hematopoietic stem cell transplant (HSCT) recipients for the prevention of clinically significant cytomegalovirus (CMV) infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letermovir | Experimental | Chinese HSCT recipients will receive 240 mg of Letermovir [for participants on Cyclosporin A (CsA)] or 480 mg of Letermovir (for participants not on CsA) either orally or IV once daily through week 14 (~100 days) post-transplant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letermovir | Drug | Daily 240 mg or 480 mg oral tablets or IV dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinically Significant Cytomegalovirus (CMV) Infection up to Week 24 Post-Transplant | Clinically significant CMV infection was defined as either one of the following: 1) initiation of anti-CMV pre-emptive therapy based on documented CMV viremia and the clinical condition of the participant or 2) onset of CMV end-organ disease. The percentage of participants with clinically significant CMV infection up to week 24 post-transplant is reported. | Up to Week 24 post-transplant (approximately 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced an Adverse Event (AE) | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE is reported. |
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The key inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital ( Site 0024) | Hefei | Anhui | 230071 | China | ||
| Peking University First Hospital ( Site 0009) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Letermovir | Chinese HSCT recipients received 240 mg of Letermovir [for participants on Cyclosporin A (CsA)] or 480 mg of Letermovir (for participants not on CsA) either orally or IV once daily through week 14 (99 days) post-transplant. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 24, 2023 |
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| Up to 16 weeks |
| Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study treatment due to an AE is reported. | Up to 14 weeks |
| Percentage of Participants With Clinically Significant CMV Infection up to Week 14 Post-Transplant | Clinically significant CMV infection was defined as either one of the following: 1) initiation of anti-CMV pre-emptive therapy based on documented CMV viremia and the clinical condition of the participant or 2) onset of CMV end-organ disease. The percentage of participants with clinically significant CMV infection up to 14 weeks post-transplant is reported. | Up to 14 weeks post-transplant (99 days) |
| Percentage of Participants With Preemptive Therapy for CMV Viremia up to Week 14 Post-Transplant | Initiation of anti-CMV preemptive therapy was based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with initiation of anti-CMV preemptive anti-CMV therapy up to 14 weeks post-transplant is reported. | Up to 14 weeks post-transplant (99 days) |
| Percentage of Participants With Preemptive Therapy for CMV Viremia up to Week 24 Post-Transplant | Initiation of anti-CMV preemptive therapy was based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with initiation of anti-CMV preemptive anti-CMV therapy up to 24 weeks post-transplant is reported. | Up to 24 weeks post-transplant (approximately 6 months) |
| Percentage of Participants With CMV End-organ Disease up to Week 14 Post-Transplant | CMV end-organ disease met per-protocol diagnostic criteria for CMV-pneumonia, gastrointestinal disease, hepatitis, central nervous system disease, retinitis, nephritis, cystitis, myocarditis, pancreatitis, or other disease categories. Only Clinical Adjudication Committee-confirmed CMV end-organ disease will be included in this analysis. The percentage of participants with CMV end-organ disease up to 14 weeks post-transplant is reported. | Up to 14 weeks post-transplant (99 days) |
| Percentage of Participants With CMV End-organ Disease up to Week 24 Post-Transplant | CMV end-organ disease met per-protocol diagnostic criteria for CMV-pneumonia, gastrointestinal disease, hepatitis, central nervous system disease, retinitis, nephritis, cystitis, myocarditis, pancreatitis, or other disease categories. Only Clinical Adjudication Committee-confirmed CMV end-organ disease will be included in this analysis. The percentage of participants with CMV end-organ disease up to 24 weeks post-transplant is reported. | Up to 24 weeks post-transplant (approximately 6 months) |
| Percentage of Participants With All-Cause Mortality up to Week 14 Post-Transplant | The percentage of participants who died due to any cause up to 14 weeks post-transplant is reported. | Up to 14 weeks post-transplant (99 days) |
| Percentage of Participants With All-cause Mortality up to Week 24 Post-Transplant | The percentage of participants who died due to any cause up to 24 weeks post-transplant is reported. | Up to 24 weeks post-transplant (approximately 6 months) |
| Beijing |
| Beijing Municipality |
| 100034 |
| China |
| Peking University People's Hospital-Hematology ( Site 0033) | Beijing | Beijing Municipality | 100034 | China |
| The Second Affiliated Hospital of Third Military Medical University-Oncology Department ( Site 0002) | Chongqing | Chongqing Municipality | 400037 | China |
| Southwest Hospital of Third Military Medical University ( Site 0005) | Chongqing | Chongqing Municipality | 400038 | China |
| The Second Affiliated Hospital Chongqing Medical University ( Site 0013) | Chongqing | Chongqing Municipality | 400072 | China |
| Guangzhou First People's Hospital-Hematology Department ( Site 0001) | Guangzhou | Guangdong | 510180 | China |
| Southern Medical University Nanfang Hospital ( Site 0003) | Guangzhou | Guangdong | 510515 | China |
| Shenzhen Second People's Hospital-Hematology Department ( Site 0006) | Shenzhen | Guangdong | 518035 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0028) | Wuhan | Hubei | 430022 | China |
| Tongji Hospital Tongji Medical,Science & Technology ( Site 0032) | Wuhan | Hubei | 430030 | China |
| The First Affiliated Hospital of Soochow University-hematology department ( Site 0029) | Suzhou | Jiangsu | 215006 | China |
| The Affiliated Hospital of Xuzhou Medical College ( Site 0022) | Xuzhou | Jiangsu | 221006 | China |
| The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 0021) | Nanchang | Jiangxi | 330209 | China |
| The First Hospital of Jilin University-Hematology ( Site 0023) | Changchun | Jilin | 130021 | China |
| The 2nd Affiliated Hospital of Dalian Medical University ( Site 0019) | Dalian | Liaoning | 116023 | China |
| Shanghai General Hospital ( Site 0018) | Shanghai | Shanghai Municipality | 200080 | China |
| West China Hospital, Sichuan University ( Site 0008) | Chengdu | Sichuan | 610041 | China |
| The General Hospital of Western Theater Command ( Site 0007) | Chengdu | Sichuan | 610083 | China |
| Institute of hematology&blood disease hospital-Hematology ( Site 0030) | Tianjin | Tianjin Municipality | 300020 | China |
| The First Affiliated Hospital, Zhejiang University ( Site 0025) | Hangzhou | Zhejiang | 310003 | China |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Letermovir | Chinese HSCT recipients received 240 mg of Letermovir [for participants on Cyclosporin A (CsA)] or 480 mg of Letermovir (for participants not on CsA) either orally or IV once daily through week 14 (99 days) post-transplant. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 With Clinically Significant Cytomegalovirus (CMV) Infection up to Week 24 Post-Transplant | Clinically significant CMV infection was defined as either one of the following: 1) initiation of anti-CMV pre-emptive therapy based on documented CMV viremia and the clinical condition of the participant or 2) onset of CMV end-organ disease. The percentage of participants with clinically significant CMV infection up to week 24 post-transplant is reported. | All allocated participants who received at least 1 dose of study treatment and have no detectable CMV viral deoxyribonucleic acid (DNA) when study intervention is initiated. Per protocol, participants who prematurely discontinued or had a missing outcome at the 24-week visit window were considered treatment failure (i.e. Non-completers equal failure [NC=F] approach was used). | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to Week 24 post-transplant (approximately 6 months) |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced an Adverse Event (AE) | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE is reported. | All allocated participants who received at least one dose of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 16 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study treatment due to an AE is reported. | All allocated participants who received at least one dose of study treatment. | Posted | Number | Percentage of Participants | Up to 14 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinically Significant CMV Infection up to Week 14 Post-Transplant | Clinically significant CMV infection was defined as either one of the following: 1) initiation of anti-CMV pre-emptive therapy based on documented CMV viremia and the clinical condition of the participant or 2) onset of CMV end-organ disease. The percentage of participants with clinically significant CMV infection up to 14 weeks post-transplant is reported. | All allocated participants who received at least 1 dose of study treatment and had no detectable CMV viral DNA when study intervention is initiated. Per protocol, participants who prematurely discontinued or had a missing outcome at the 14-week visit window were considered treatment failure (i.e. Non-completers equal failure [NC=F] approach was used). | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 14 weeks post-transplant (99 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Preemptive Therapy for CMV Viremia up to Week 14 Post-Transplant | Initiation of anti-CMV preemptive therapy was based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with initiation of anti-CMV preemptive anti-CMV therapy up to 14 weeks post-transplant is reported. | All allocated participants who received at least 1 dose of study treatment and had no detectable CMV viral DNA when study intervention is initiated. Per protocol, participants who prematurely discontinued or had a missing outcome at the 14-week visit window were considered treatment failure (i.e. Non-completers equal failure [NC=F] approach was used). | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 14 weeks post-transplant (99 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Preemptive Therapy for CMV Viremia up to Week 24 Post-Transplant | Initiation of anti-CMV preemptive therapy was based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with initiation of anti-CMV preemptive anti-CMV therapy up to 24 weeks post-transplant is reported. | All allocated participants who received at least 1 dose of study treatment and had no detectable CMV viral DNA when study intervention is initiated. Per protocol, participants who prematurely discontinued or had a missing outcome at the 24-week visit window were considered treatment failure (i.e. Non-completers equal failure [NC=F] approach was used). | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 24 weeks post-transplant (approximately 6 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With CMV End-organ Disease up to Week 14 Post-Transplant | CMV end-organ disease met per-protocol diagnostic criteria for CMV-pneumonia, gastrointestinal disease, hepatitis, central nervous system disease, retinitis, nephritis, cystitis, myocarditis, pancreatitis, or other disease categories. Only Clinical Adjudication Committee-confirmed CMV end-organ disease will be included in this analysis. The percentage of participants with CMV end-organ disease up to 14 weeks post-transplant is reported. | All allocated participants who received at least 1 dose of study treatment and had no detectable CMV viral DNA when study intervention is initiated. Per protocol, participants who prematurely discontinued or had a missing outcome at the 14-week visit window were considered treatment failure (i.e. Non-completers equal failure [NC=F] approach was used). | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 14 weeks post-transplant (99 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With CMV End-organ Disease up to Week 24 Post-Transplant | CMV end-organ disease met per-protocol diagnostic criteria for CMV-pneumonia, gastrointestinal disease, hepatitis, central nervous system disease, retinitis, nephritis, cystitis, myocarditis, pancreatitis, or other disease categories. Only Clinical Adjudication Committee-confirmed CMV end-organ disease will be included in this analysis. The percentage of participants with CMV end-organ disease up to 24 weeks post-transplant is reported. | All allocated participants who received at least 1 dose of study treatment and had no detectable CMV viral DNA when study intervention is initiated. Per protocol, participants who prematurely discontinued or had a missing outcome at the 24-week visit window were considered treatment failure (i.e. Non-completers equal failure [NC=F] approach was used). | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 24 weeks post-transplant (approximately 6 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With All-Cause Mortality up to Week 14 Post-Transplant | The percentage of participants who died due to any cause up to 14 weeks post-transplant is reported. | All allocated participants who received at least 1 dose of study treatment and had no detectable CMV viral DNA when study intervention is initiated. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 14 weeks post-transplant (99 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With All-cause Mortality up to Week 24 Post-Transplant | The percentage of participants who died due to any cause up to 24 weeks post-transplant is reported. | All allocated participants who received at least 1 dose of study treatment and had no detectable CMV viral DNA when study intervention is initiated. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 24 weeks post-transplant (approximately 6 months) |
|
|
Up to 6 months
All cause mortality is reported for all allocated participants. Serious adverse events and other adverse events are reported for all allocated participants who received at least 1 dose of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Letermovir | Chinese HSCT recipients received 240 mg of Letermovir [for participants on Cyclosporin A (CsA)] or 480 mg of Letermovir (for participants not on CsA) either orally or IV once daily through week 14 (99 days) post-transplant. | 8 | 120 | 70 | 120 | 118 | 120 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Atypical haemolytic uraemic syndrome | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dysbiosis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Sudden cardiac death | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Hepatic failure | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
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| Liver injury | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute graft versus host disease | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
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| Acute graft versus host disease in intestine | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
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| Acute graft versus host disease in skin | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
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| Chronic graft versus host disease in intestine | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
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| Graft versus host disease | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
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| Bacterial infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Coronavirus infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Cytomegalovirus infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Cytomegalovirus viraemia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Epstein-Barr viraemia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Epstein-Barr virus infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Pneumonia fungal | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Pulmonary tuberculosis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute lymphocytic leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
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| Acute lymphocytic leukaemia refractory | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
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| Acute promyelocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Post transplant lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
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| Altered state of consciousness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Cerebrovascular disorder | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Axillary vein thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypofibrinogenaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute graft versus host disease | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Epstein-Barr virus infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
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If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Mar 3, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000588473 | letermovir |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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