NCT04312841 · OUTCOME
Number of Participants With Adverse Events Grade 3 or Above
Letermovir for the Prevention of Cytomegalovirus Reactivation in Patients With Hematological Malignancies Treated With Alemtuzumab · Source last updated 2025-02-28
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 30 days post treatment, an average of 5 months
What was measured
Adverse event data will be described and graded per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 guidelines. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns, especially for grade 3 or above adverse events. To assess tolerability, will also capture the proportion of patients who go off treatment due to adverse events.
Groups in this outcome
Treatment (Letermovir)
Beginning within 7 days of the first administration of standard alemtuzumab, patients receive letermovir PO (or IV over 1 hour if patient is unable to take PO for an extended period of time) daily on days 1-28. Cycles repeat every 28 days for up to 3 months after the last dose of alemtuzumab in the absence of unacceptable toxicity.
Letermovir: Given PO
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Treatment (Letermovir) | 6 |
|---|
Reported measurements
Platelet count decreased
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment (Letermovir) | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Anemia
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment (Letermovir) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Diarrhea
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment (Letermovir) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
White blood cell decreased
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment (Letermovir) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Activated partial thromboplastin time prolonged
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment (Letermovir) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Alkaline phosphatase increased
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment (Letermovir) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Lymphocyte count decreased
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment (Letermovir) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Neutrophil count decreased
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment (Letermovir) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Sinus bradycardia
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Treatment (Letermovir) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- Platelet count decreased
- title
- Anemia
- title
- Diarrhea
- title
- White blood cell decreased
- title
- Activated partial thromboplastin time prolonged
- title
- Alkaline phosphatase increased
- title
- Lymphocyte count decreased
- title
- Neutrophil count decreased
- title
- Sinus bradycardia
- description
- Adverse event data will be described and graded per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 guidelines. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns, especially for grade 3 or above adverse events. To assess tolerability, will also capture the proportion of patients who go off treatment due to adverse events.
- groups
- description
- Beginning within 7 days of the first administration of standard alemtuzumab, patients receive letermovir PO (or IV over 1 hour if patient is unable to take PO for an extended period of time) daily on days 1-28. Cycles repeat every 28 days for up to 3 months after the last dose of alemtuzumab in the absence of unacceptable toxicity.
Letermovir: Given PO
- id
- OG000
- title
- Treatment (Letermovir)
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Up to 30 days post treatment, an average of 5 months
- title
- Number of Participants With Adverse Events Grade 3 or Above
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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