Trial Outcomes & Findings for Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors (NCT NCT04985604)
NCT ID: NCT04985604
Last Updated: 2025-10-02
Results Overview
ORR was defined as the percentage of participants with the best overall confirmed response of complete response (CR) or partial response (PR) according to the appropriate response assessment criteria including Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) for the disease setting as assessed by the Investigator. CR or PR was confirmed at a subsequent scan (\>=4 weeks) if the criteria for each are met . The exact 95% confidence intervals (CIs) were calculated using Clopper-Pearson method.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Up to 23 months
Results posted on
2025-10-02
Participant Flow
This study was conducted at 11 centers that enrolled participants in 6 countries.
A total of 31 participants consented, of which 23 participants were enrolled into Melanoma and Tissue Agnostic cohorts. Remaining 8 participants were screen failures.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
15
|
|
Overall Study
COMPLETED
|
4
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Death
|
4
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors
Baseline characteristics by cohort
| Measure |
Melanoma Cohort
n=8 Participants
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
|
Tissue Agnostic Cohort
n=15 Participants
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.0 Years
n=5 Participants
|
45.0 Years
n=7 Participants
|
53.0 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 23 monthsPopulation: Efficacy Analysis Set comprises of all participants who received at least one dose of study drug and have measurable disease as determined by the Investigator at baseline.
ORR was defined as the percentage of participants with the best overall confirmed response of complete response (CR) or partial response (PR) according to the appropriate response assessment criteria including Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) for the disease setting as assessed by the Investigator. CR or PR was confirmed at a subsequent scan (\>=4 weeks) if the criteria for each are met . The exact 95% confidence intervals (CIs) were calculated using Clopper-Pearson method.
Outcome measures
| Measure |
Melanoma Cohort
n=8 Participants
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
|
Tissue Agnostic Cohort
n=15 Participants
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
|
|---|---|---|
|
Overall Response Rate (ORR) by the Investigator
|
50.0 Percentage of participants
Interval 15.7 to 84.3
|
40.0 Percentage of participants
Interval 16.3 to 67.7
|
SECONDARY outcome
Timeframe: Up to 23 monthsPopulation: Safety Analysis Set comprises of all patients enrolled in the study who receive at least one dose of study drug.
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.
Outcome measures
| Measure |
Melanoma Cohort
n=8 Participants
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
|
Tissue Agnostic Cohort
n=15 Participants
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE
|
8 Participants
|
15 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAEs Related to Study Drug
|
8 Participants
|
13 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any serious TEAE
|
2 Participants
|
8 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Serious TEAEs Related to Study Drug
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAEs with Severity Grade 3 or Higher
|
5 Participants
|
8 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAEs Related to Study Drug with Severity Grade 3 or Higher
|
2 Participants
|
3 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAEs Leading to Death
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAEs Related to Study Drug Leading to Death
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAEs Leading to Study Drug Discontinuation
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAEs Related to Study Drug Leading to Study Drug Discontinuation
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to 23 monthsPopulation: Safety Analysis Set comprises of all patients enrolled in the study who receive at least one dose of study drug.
Blood samples were collected for the analysis of following hematology parameters: anemia, neutrophil count decreased and white blood cell decreased. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G2, G3, and G4 are presented. The laboratory parameters were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Outcome measures
| Measure |
Melanoma Cohort
n=8 Participants
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
|
Tissue Agnostic Cohort
n=15 Participants
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
|
|---|---|---|
|
Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-baseline Relative to Baseline
Neutrophil count decreased, Increased to Grade 2
|
0 Participants
|
2 Participants
|
|
Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-baseline Relative to Baseline
Anemia, Increased to Grade 2
|
3 Participants
|
5 Participants
|
|
Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-baseline Relative to Baseline
Anemia, Increased to Grade 3
|
2 Participants
|
2 Participants
|
|
Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-baseline Relative to Baseline
Anemia, Increased to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-baseline Relative to Baseline
Neutrophil count decreased, Increased to Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-baseline Relative to Baseline
Neutrophil count decreased, Increased to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-baseline Relative to Baseline
White blood cell decreased, Increased to Grade 2
|
0 Participants
|
2 Participants
|
|
Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-baseline Relative to Baseline
White blood cell decreased, Increased to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Results by Maximum Grade Increase Post-baseline Relative to Baseline
White blood cell decreased, Increased to Grade 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to 23 monthsPopulation: Safety Analysis Set comprises of all patients enrolled in the study who receive at least one dose of study drug.
Blood samples were collected for the analysis of following chemistry parameters: creatine phosphokinase (CPK) increased, hypokalemia, hypoalbuminemia, hypercalcemia, hypocalcemia and hyponatremia. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G2, G3, and G4 are presented. The laboratory parameters were graded according to CTCAE version 5.
Outcome measures
| Measure |
Melanoma Cohort
n=8 Participants
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
|
Tissue Agnostic Cohort
n=15 Participants
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
|
|---|---|---|
|
Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline
CPK increased, Increased to Grade 2
|
2 Participants
|
4 Participants
|
|
Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline
CPK increased, Increased to Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline
CPK increased, Increased to Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline
Hypoalbuminemia, Increased to Grade 2
|
1 Participants
|
2 Participants
|
|
Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline
Hypoalbuminemia, Increased to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline
Hypoalbuminemia, Increased to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline
Hypokalemia, Increased to Grade 2
|
1 Participants
|
5 Participants
|
|
Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline
Hypokalemia, Increased to Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline
Hypokalemia, Increased to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline
Hyponatremia, Increased to Grade 2
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline
Hyponatremia, Increased to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline
Hyponatremia, Increased to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline
Hypercalcemia, Increased to Grade 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline
Hypercalcemia, Increased to Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline
Hypercalcemia, Increased to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline
Hypocalcemia, Increased to Grade 2
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline
Hypocalcemia, Increased to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline
Hypocalcemia, Increased to Grade 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 23 monthsPopulation: Participants in the Efficacy Analysis Set who have a confirmed response of CR or PR.
Duration of response was defined as the interval from the date of the first documentation of tumor response (CR or PR) that was subsequently confirmed by investigator assessment to the date of first occurrence of radiographic disease progression based on RECIST 1.1 or RANO criteria or death due to any cause, whichever occurs earlier. DOR was estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Melanoma Cohort
n=4 Participants
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
|
Tissue Agnostic Cohort
n=6 Participants
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
|
|---|---|---|
|
Duration of Response (DOR) in Participants With Best Overall Response
|
5.6 Months
Interval 3.0 to
The upper bound of the 95% confidence interval was not estimable due to insufficient number of participants with events at the tail of the Kaplan-Meier curve.
|
9.2 Months
Interval 3.5 to
The upper bound of the 95% confidence interval was not estimable due to insufficient number of participants with events at the tail of the Kaplan-Meier curve.
|
SECONDARY outcome
Timeframe: Up to 23 monthsPopulation: Efficacy Analysis Set comprises of all participants who received at least one dose of study drug and have measurable disease as determined by the Investigator at baseline.
Progression free survival was defined as the interval from the date of the first dose to the first occurrence of radiographic disease progression based on RECIST 1.1 or RANO criteria or death due to any cause, whichever occurs earlier. Progression free survival was estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Melanoma Cohort
n=8 Participants
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
|
Tissue Agnostic Cohort
n=15 Participants
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
|
|---|---|---|
|
Duration of Progression Free Survival
|
5.5 Months
Interval 1.8 to 12.5
|
5.5 Months
Interval 1.7 to
The upper bound of the 95% confidence interval was not estimable due to insufficient number of participants with events at the tail of the Kaplan-Meier curve.
|
SECONDARY outcome
Timeframe: Up to 23 monthsPopulation: Efficacy Analysis Set comprises of all participants who received at least one dose of study drug and have measurable disease as determined by the Investigator at baseline.
Overall survival is defined as the interval from the date of the first dose until the recorded date of death due to any cause. Overall survival was estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Melanoma Cohort
n=8 Participants
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
|
Tissue Agnostic Cohort
n=15 Participants
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
|
|---|---|---|
|
Duration of Overall Survival
|
18.9 Months
Interval 3.4 to
The upper bound of the 95% confidence interval was not estimable due to insufficient number of participants with events at the tail of the Kaplan-Meier curve.
|
NA Months
Interval 5.5 to
The median and upper bound of the 95% confidence interval was not estimable due to insufficient number of participants with events at the tail of the Kaplan-Meier curve.
|
SECONDARY outcome
Timeframe: Up to 23 monthsPopulation: Participants in the Efficacy Analysis Set who have a confirmed response of CR or PR were analyzed.
Time to Response was defined in participants with best overall response of complete response or partial response as determined by Investigator. It is the interval from the date of the first dose to date of first documentation of tumor response that was subsequently confirmed by investigator assessment.
Outcome measures
| Measure |
Melanoma Cohort
n=4 Participants
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
|
Tissue Agnostic Cohort
n=6 Participants
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
|
|---|---|---|
|
Time to Response
|
1.76 Months
Interval 1.66 to 6.44
|
1.82 Months
Interval 1.77 to 1.87
|
Adverse Events
Melanoma Cohort
Serious events: 2 serious events
Other events: 8 other events
Deaths: 4 deaths
Tissue Agnostic Cohort
Serious events: 8 serious events
Other events: 15 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Melanoma Cohort
n=8 participants at risk
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
|
Tissue Agnostic Cohort
n=15 participants at risk
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
0.00%
0/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
General disorders
Oedema
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
0.00%
0/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
Other adverse events
| Measure |
Melanoma Cohort
n=8 participants at risk
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
|
Tissue Agnostic Cohort
n=15 participants at risk
Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
37.5%
3/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
20.0%
3/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
26.7%
4/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
20.0%
3/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
13.3%
2/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
13.3%
2/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
13.3%
2/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
0.00%
0/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
General disorders
Face oedema
|
37.5%
3/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
13.3%
2/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
General disorders
Asthenia
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
26.7%
4/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
General disorders
Fatigue
|
50.0%
4/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
0.00%
0/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
General disorders
Oedema
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
13.3%
2/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
General disorders
Oedema peripheral
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
20.0%
3/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
20.0%
3/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
General disorders
Chills
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
General disorders
Gait disturbance
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
General disorders
Generalised oedema
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
General disorders
Influenza like illness
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
General disorders
Mucosal inflammation
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
0.00%
0/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
37.5%
3/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
26.7%
4/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Skin and subcutaneous tissue disorders
Rash
|
37.5%
3/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
20.0%
3/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
26.7%
4/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
26.7%
4/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
2/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
13.3%
2/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
20.0%
3/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Skin and subcutaneous tissue disorders
Acne
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
0.00%
0/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
0.00%
0/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Blood and lymphatic system disorders
Anaemia
|
62.5%
5/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
46.7%
7/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
0.00%
0/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Investigations
Blood creatine phosphokinase increased
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
33.3%
5/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
13.3%
2/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Investigations
Weight decreased
|
25.0%
2/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
13.3%
2/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Investigations
Blood bilirubin increased
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
0.00%
0/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Investigations
Blood calcium decreased
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Investigations
Tri-iodothyronine increased
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Investigations
Troponin I increased
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
40.0%
6/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
13.3%
2/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
0.00%
0/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
2/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
13.3%
2/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
20.0%
3/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
13.3%
2/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
0.00%
0/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Nervous system disorders
Dysgeusia
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
13.3%
2/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Nervous system disorders
Migraine
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
0.00%
0/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Nervous system disorders
Pyramidal tract syndrome
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
20.0%
3/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
20.0%
3/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
13.3%
2/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
0.00%
0/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
13.3%
2/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Eye disorders
Vision blurred
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
13.3%
2/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Eye disorders
Blepharitis
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Eye disorders
Dry eye
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Eye disorders
Eye disorder
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Infections and infestations
Influenza
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
13.3%
2/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
13.3%
2/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Infections and infestations
COVID-19
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
0.00%
0/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Infections and infestations
Cystitis
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
25.0%
2/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
0.00%
0/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Psychiatric disorders
Depression
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
13.3%
2/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Vascular disorders
Embolism
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
0.00%
0/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Vascular disorders
Orthostatic hypotension
|
12.5%
1/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
0.00%
0/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/8 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
6.7%
1/15 • Up to 23 months
TEAE and serious TEAE were analyzed in Safety Analysis Set which comprised of all participants enrolled in the study who received at least one dose of tovorafenib.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER