NCT04985604 · OUTCOME
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors · Source last updated 2025-10-02
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 23 months
What was measured
An adverse event (AE) is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. An AE is considered to be treatment-emergent if it has a start date/time on or after the first administration of study drug until 30 days after the last dose of study drug and before the start of subsequent therapy, whichever comes earlier. The distribution of AEs was analyzed by the type, frequency and severity for TEAEs.
Analysis population: Safety Analysis Set comprises of all patients enrolled in the study who receive at least one dose of study drug.
Groups in this outcome
Melanoma Cohort
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
Tissue Agnostic Cohort
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
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 |
|---|
| Melanoma Cohort | 8 |
|---|
| Tissue Agnostic Cohort | 15 |
|---|
Reported measurements
Any TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Melanoma Cohort | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tissue Agnostic Cohort | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAEs Related to Study Drug
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Melanoma Cohort | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tissue Agnostic Cohort | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Any serious TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Melanoma Cohort | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tissue Agnostic Cohort | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Serious TEAEs Related to Study Drug
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Melanoma Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tissue Agnostic Cohort | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAEs with Severity Grade 3 or Higher
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Melanoma Cohort | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tissue Agnostic Cohort | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAEs Related to Study Drug with Severity Grade 3 or Higher
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Melanoma Cohort | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tissue Agnostic Cohort | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAEs Leading to Death
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Melanoma Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tissue Agnostic Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAEs Related to Study Drug Leading to Death
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Melanoma Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tissue Agnostic Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAEs Leading to Study Drug Discontinuation
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Melanoma Cohort | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tissue Agnostic Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAEs Related to Study Drug Leading to Study Drug Discontinuation
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Melanoma Cohort | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Tissue Agnostic Cohort | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 15
- title
- Any TEAE
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 13
- title
- TEAEs Related to Study Drug
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 8
- title
- Any serious TEAE
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Serious TEAEs Related to Study Drug
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 8
- title
- TEAEs with Severity Grade 3 or Higher
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- title
- TEAEs Related to Study Drug with Severity Grade 3 or Higher
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- TEAEs Leading to Death
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- TEAEs Related to Study Drug Leading to Death
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- TEAEs Leading to Study Drug Discontinuation
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- TEAEs Related to Study Drug Leading to Study Drug Discontinuation
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 15
- units
- Participants
- description
- An adverse event (AE) is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. An AE is considered to be treatment-emergent if it has a start date/time on or after the first administration of study drug until 30 days after the last dose of study drug and before the start of subsequent therapy, whichever comes earlier. The distribution of AEs was analyzed by the type, frequency and severity for TEAEs.
- groups
- description
- Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
- id
- OG000
- title
- Melanoma Cohort
- description
- Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
- id
- OG001
- title
- Tissue Agnostic Cohort
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Analysis Set comprises of all patients enrolled in the study who receive at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- Up to 23 months
- title
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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