Trial Outcomes & Findings for Phase 1 Safety Study of Encorafenib in Chinese Patients With Advanced Metastatic BRAF V600E Mutant Solid Tumors (NCT NCT05003622)
NCT ID: NCT05003622
Last Updated: 2024-06-24
Results Overview
The primary endpoint was the number of patients experiencing dose limiting toxicity (DLT) occurring within the first 28 days of study treatment (Cycle 1). A DLT was defined as any adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness or concomitant medications/therapies resulting in the inability to tolerate at least 75% dose intensity \[(administered dose in mg/planned dose in mg) × 100\] that satisfied at least one of the prespecified criteria.
COMPLETED
PHASE1
3 participants
At the end of Cycle 1. Each cycle was 28 days.
2024-06-24
Participant Flow
This study had no fixed duration and participants were expected to be treated until progressive disease. The three enrolled participants were to be treated until death, disease progression.
Participant milestones
| Measure |
Encorafenib
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Encorafenib
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Overall Study
Progressive disease
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Phase 1 Safety Study of Encorafenib in Chinese Patients With Advanced Metastatic BRAF V600E Mutant Solid Tumors
Baseline characteristics by cohort
| Measure |
Encorafenib
n=3 Participants
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 0 • n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
China
|
3 participants
n=93 Participants
|
|
Weight
|
65.73 kilograms
STANDARD_DEVIATION 4.87 • n=93 Participants
|
|
Height
|
163.07 centimeters
STANDARD_DEVIATION 5.01 • n=93 Participants
|
|
Body Mass Index
|
24.773 kilograms/meters squared
STANDARD_DEVIATION 2.437 • n=93 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Performance Status 0
|
0 Participants
n=93 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Performance Status 1
|
3 Participants
n=93 Participants
|
|
Smoking history
Never smoked
|
0 Participants
n=93 Participants
|
|
Smoking history
Stopped smoking more than or equal to 10 years ago
|
0 Participants
n=93 Participants
|
|
Smoking history
Stopped smoking less than 10 years ago
|
3 Participants
n=93 Participants
|
|
Smoking history
Smoker
|
0 Participants
n=93 Participants
|
|
BRAF V600E Mutation Result (Local)
Positive
|
3 Participants
n=93 Participants
|
|
BRAF V600E Mutation Result (Local)
Negative
|
0 Participants
n=93 Participants
|
|
Diagnosis at study entry
Metastatic Melanoma
|
0 Participants
n=93 Participants
|
|
Diagnosis at study entry
Metastatic NSCLC
|
3 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: At the end of Cycle 1. Each cycle was 28 days.Population: Dose-determining Set. The Dose-determining set consisted of all evaluable participants from the Safety Analysis Set who either achieved the minimum exposure requirement (i.e., encorafenib dose intensity of 75% in Cycle 1) and had sufficient safety evaluations.
The primary endpoint was the number of patients experiencing dose limiting toxicity (DLT) occurring within the first 28 days of study treatment (Cycle 1). A DLT was defined as any adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness or concomitant medications/therapies resulting in the inability to tolerate at least 75% dose intensity \[(administered dose in mg/planned dose in mg) × 100\] that satisfied at least one of the prespecified criteria.
Outcome measures
| Measure |
Encorafenib
n=3 Participants
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Dose Limiting Toxicities (DLTs) Experienced During Cycle 1
|
0 participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 through safety follow-up visit (30 days after end of treatment (EOT) visit or 7 days after end EOT visit/last dose if EOT not performed), approximately up to 6 months. Each cycle was 28 days.Population: Safety Analysis Set
The occurrences of treatment emergent adverse events (TEAEs) graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03, TEAEs leading to dose interruption, reduction and discontinuation, treatment-emergent serious adverse events (SAEs) and deaths were reported. The number of events occurring in the three participants is presented.
Outcome measures
| Measure |
Encorafenib
n=3 Participants
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
TEAEs Overall
|
53 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
TEAEs Related
|
17 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
TEAEs Grade 3+
|
3 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
TEAEs Related Grade 3+
|
2 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Serious TEAE Overall
|
3 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Serious TEAE Related
|
2 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Serious TEAE Grade 3+
|
2 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Serious TEAE Related Grade 3+
|
1 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Serious TEAE Leading to Death
|
0 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
TEAE by severity grade Grade 1
|
37 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
TEAE by severity grade Grade 2
|
13 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
TEAE by severity grade Grade 3
|
3 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
TEAE leading to discontinuation of encorafenib regardless of causality Overall
|
0 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
TEAEs leading to encorafenib dose modification (interruption or reduction) Overall
|
6 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
TEAEs leading to encorafenib dose modification (interruption or reduction) Related
|
4 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
TEAEs leading to encorafenib dose modification (interruption or reduction) Grade 3+
|
1 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
TEAEs leading to encorafenib dose modification (interruption or reduction) Related Grade 3+
|
1 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
TEAEs leading to encorafenib drug interruption Overall
|
5 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
TEAEs leading to encorafenib drug interruption Related
|
4 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
TEAEs leading to encorafenib drug interruption Grade 3+
|
1 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
TEAEs leading to encorafenib drug interruption Related Grade 3+
|
1 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
TEAEs leading to encorafenib dose reduction Overall
|
1 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
TEAE action taken with encorafenib Dose not Change
|
47 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
TEAE action taken with encorafenib Dose Reduced
|
1 events
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
TEAE action taken with encorafenib Drug Interrupted
|
5 events
|
SECONDARY outcome
Timeframe: Screening (Days -28 to -1), Cycle 1 Day 1 (if not done within 72 hours before the first dose), Cycle 1 Day 15, on Day 1 each subsequent cycle, end of treatment visit 30 day safety follow up visit, approximately up to 6 months. Each cycle was 28 days.Population: Safety Analysis Set
Clinically notable shift from baseline in blood hematology parameters data \[Hemoglobin (Low/High); Leukocytes (Low/ High); Neutrophils (Low); Platelets (Low); Lymphocytes (Low/High)\] was graded using NCI CTCAE Version 4.03. Clinically notable shift was defined as a worsening from baseline by at least 2 grades, or to grade 3 or above. The number of participants with clinically notable shift from baseline is presented.
Outcome measures
| Measure |
Encorafenib
n=3 Participants
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Notable Change From Baseline of Blood Hematology Parameters: Hemoglobin, Leukocytes, Neutrophils, Platelets, Lymphocytes.
Hemoglobin (g/L) (Low)
|
0 Participants
|
|
Notable Change From Baseline of Blood Hematology Parameters: Hemoglobin, Leukocytes, Neutrophils, Platelets, Lymphocytes.
Hemoglobin (g/L) (High)
|
0 Participants
|
|
Notable Change From Baseline of Blood Hematology Parameters: Hemoglobin, Leukocytes, Neutrophils, Platelets, Lymphocytes.
Platelets (10^9/L) (Low)
|
0 Participants
|
|
Notable Change From Baseline of Blood Hematology Parameters: Hemoglobin, Leukocytes, Neutrophils, Platelets, Lymphocytes.
Leukocytes (10^9/L) (Low)
|
0 Participants
|
|
Notable Change From Baseline of Blood Hematology Parameters: Hemoglobin, Leukocytes, Neutrophils, Platelets, Lymphocytes.
Leukocytes (10^9/L) (High)
|
0 Participants
|
|
Notable Change From Baseline of Blood Hematology Parameters: Hemoglobin, Leukocytes, Neutrophils, Platelets, Lymphocytes.
Lymphocytes (10^9/L) (Low)
|
0 Participants
|
|
Notable Change From Baseline of Blood Hematology Parameters: Hemoglobin, Leukocytes, Neutrophils, Platelets, Lymphocytes.
Lymphocytes (10^9/L) (High)
|
0 Participants
|
|
Notable Change From Baseline of Blood Hematology Parameters: Hemoglobin, Leukocytes, Neutrophils, Platelets, Lymphocytes.
Neutrophils (10^9/L) (Low)
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening (Days -28 to -1), Cycle 1 Day 1 (if not done within 72 hours before the first dose), Cycle 1 Day 15, on Day 1 each subsequent cycle, end of treatment visit 30 day safety follow up visit, approximately up to 6 months. Each cycle was 28 days.Population: Safety Analysis Set
Clinically notable shift from baseline in blood clinical chemistry parameter values \[Phosphate (Low); Alanine Aminotransferase (High); Albumin (Low); Alkaline Phosphatase (High); Aspartate Aminotransferase (High); Bilirubin (High); Calcium Corrected (Low/High); Creatinine (High); Glucose (Low/High); Magnesium (Low/High); Potassium (Low/High); Sodium (Low/High); amylase (high); Gamma Glutamyl Transferase (High); Lipase (High) and Urate (High)\] was graded using NCI-CTCAE, Version 4.03. Clinically notable shift was defined as a worsening from baseline by at least 2 grades, or to grade 3 or above. Number of participants with at least one clinically notable shift during study was reported.
Outcome measures
| Measure |
Encorafenib
n=3 Participants
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Notable Change From Baseline of Blood Clinical Chemistry Parameters
Albumin (g/L) (Low)
|
0 Participants
|
|
Notable Change From Baseline of Blood Clinical Chemistry Parameters
Alkaline Phosphatase (IU/L) (High)
|
0 Participants
|
|
Notable Change From Baseline of Blood Clinical Chemistry Parameters
Alanine Aminotransferase (IU/L) (High)
|
0 Participants
|
|
Notable Change From Baseline of Blood Clinical Chemistry Parameters
Aspartate Aminotransferase (IU/L) (High)
|
0 Participants
|
|
Notable Change From Baseline of Blood Clinical Chemistry Parameters
Bilirubin (umol/L) (High)
|
0 Participants
|
|
Notable Change From Baseline of Blood Clinical Chemistry Parameters
Calcium Corrected (mmol/L) (Low)
|
0 Participants
|
|
Notable Change From Baseline of Blood Clinical Chemistry Parameters
Calcium Corrected (mmol/L) (High)
|
0 Participants
|
|
Notable Change From Baseline of Blood Clinical Chemistry Parameters
Creatine Kinase (IU/L) (High)
|
0 Participants
|
|
Notable Change From Baseline of Blood Clinical Chemistry Parameters
Creatinine (umol/L) (High)
|
0 Participants
|
|
Notable Change From Baseline of Blood Clinical Chemistry Parameters
Gamma Glutamyl Transferase (IU/L) (High)
|
0 Participants
|
|
Notable Change From Baseline of Blood Clinical Chemistry Parameters
Glucose (mmol/L) (Low)
|
0 Participants
|
|
Notable Change From Baseline of Blood Clinical Chemistry Parameters
Glucose (mmol/L) (High)
|
1 Participants
|
|
Notable Change From Baseline of Blood Clinical Chemistry Parameters
Lipase (IU/L) (High)
|
1 Participants
|
|
Notable Change From Baseline of Blood Clinical Chemistry Parameters
Amylase (IU/L) (High)
|
0 Participants
|
|
Notable Change From Baseline of Blood Clinical Chemistry Parameters
Magnesium (mmol/L) (Low)
|
0 Participants
|
|
Notable Change From Baseline of Blood Clinical Chemistry Parameters
Magnesium (mmol/L) (High)
|
0 Participants
|
|
Notable Change From Baseline of Blood Clinical Chemistry Parameters
Phosphate (mmol/L) (Low)
|
0 Participants
|
|
Notable Change From Baseline of Blood Clinical Chemistry Parameters
Potassium (mmol/L) (Low)
|
0 Participants
|
|
Notable Change From Baseline of Blood Clinical Chemistry Parameters
Potassium (mmol/L) (High)
|
0 Participants
|
|
Notable Change From Baseline of Blood Clinical Chemistry Parameters
Sodium (mmol/L) (Low)
|
0 Participants
|
|
Notable Change From Baseline of Blood Clinical Chemistry Parameters
Sodium (mmol/L) (High)
|
0 Participants
|
|
Notable Change From Baseline of Blood Clinical Chemistry Parameters
Urate (umol/L) (High)
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening (Days -28 to -1), Cycle 1 Day 1 (if not done within 72 hours before the first dose), Cycle 1 Day 15, on Day 1 each subsequent cycle, end of treatment visit 30 day safety follow up visit, approximately up to 6 months. Each cycle was 28 days.Population: Safety Analysis Set
The maximum post baseline values of coagulation parameters \[activated partial thromboplastin time (seconds) and prothtombin international normalized ratio (INR)\]. It was graded using NCI-CTCAE, Version 4.03. The number of participants is presented with their worst NCI-CTCAE grade post-baseline. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting ageappropriate instrumental ADL\*. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL\*\*. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Outcome measures
| Measure |
Encorafenib
n=3 Participants
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Notable Change From Baseline of Coagulation Parameters
Activated Partial Thromboplastin Time (sec) · Grade 0
|
3 Participants
|
|
Notable Change From Baseline of Coagulation Parameters
Activated Partial Thromboplastin Time (sec) · Grade 1
|
0 Participants
|
|
Notable Change From Baseline of Coagulation Parameters
Activated Partial Thromboplastin Time (sec) · Grade 2
|
0 Participants
|
|
Notable Change From Baseline of Coagulation Parameters
Activated Partial Thromboplastin Time (sec) · Grade 3
|
0 Participants
|
|
Notable Change From Baseline of Coagulation Parameters
Activated Partial Thromboplastin Time (sec) · Grade 4
|
0 Participants
|
|
Notable Change From Baseline of Coagulation Parameters
Prothrombin International Normalized Ratio (RATIO) · Grade 0
|
2 Participants
|
|
Notable Change From Baseline of Coagulation Parameters
Prothrombin International Normalized Ratio (RATIO) · Grade 1
|
1 Participants
|
|
Notable Change From Baseline of Coagulation Parameters
Prothrombin International Normalized Ratio (RATIO) · Grade 2
|
0 Participants
|
|
Notable Change From Baseline of Coagulation Parameters
Prothrombin International Normalized Ratio (RATIO) · Grade 3
|
0 Participants
|
|
Notable Change From Baseline of Coagulation Parameters
Prothrombin International Normalized Ratio (RATIO) · Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: Days -28 to -1, Cycle1 Day1 (if not within 72 hours before first dose),Cycle1 Day15,on Day1 each subsequent cycle,end of treatment visit 30 day safety follow up visit, up to 6 months. Additional urinalysis in Cycle 1 Days 8 and 22. Each cycle was 28 days.Population: Safety Analysis Set
The appearance of dipstick, at each visit by participant is presented.
Outcome measures
| Measure |
Encorafenib
n=3 Participants
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Notable Change From Baseline of Dipstick Urinalysis
Baseline · Clear
|
3 Participants
|
|
Notable Change From Baseline of Dipstick Urinalysis
Baseline · Cloudy
|
0 Participants
|
|
Notable Change From Baseline of Dipstick Urinalysis
Cycle 1 Day 8 · Clear
|
3 Participants
|
|
Notable Change From Baseline of Dipstick Urinalysis
Cycle 1 Day 8 · Cloudy
|
0 Participants
|
|
Notable Change From Baseline of Dipstick Urinalysis
Cycle 1 Day 15 · Clear
|
3 Participants
|
|
Notable Change From Baseline of Dipstick Urinalysis
Cycle 1 Day 15 · Cloudy
|
0 Participants
|
|
Notable Change From Baseline of Dipstick Urinalysis
Cycle 1 Day 22 · Clear
|
3 Participants
|
|
Notable Change From Baseline of Dipstick Urinalysis
Cycle 1 Day 22 · Cloudy
|
0 Participants
|
|
Notable Change From Baseline of Dipstick Urinalysis
Cycle 2 Day 1 · Clear
|
3 Participants
|
|
Notable Change From Baseline of Dipstick Urinalysis
Cycle 2 Day 1 · Cloudy
|
0 Participants
|
|
Notable Change From Baseline of Dipstick Urinalysis
Cycle 3 Day 1 · Clear
|
2 Participants
|
|
Notable Change From Baseline of Dipstick Urinalysis
Cycle 3 Day 1 · Cloudy
|
1 Participants
|
|
Notable Change From Baseline of Dipstick Urinalysis
Cycle 4 Day 1 · Clear
|
3 Participants
|
|
Notable Change From Baseline of Dipstick Urinalysis
Cycle 4 Day 1 · Cloudy
|
0 Participants
|
SECONDARY outcome
Timeframe: Screening (Days -28 to -1), Cycle 1 Days 1, 8, 15 and 22, Day 1 of each subsequent cycle, the end of treatment visit and the 30-day safety follow-up visit, approximately up to 6 months. Each cycle was 28 days.Population: Safety Analysis Set
Clinically notable elevated values: Systolic blood pressure (SBP): ≥ 160 mmHg and an increase ≥ 20 mmHg from baseline; Diastolic blood pressure (DBP): ≥ 100 mmHg and an increase ≥ 15 mmHg from baseline; Heart rate : ≥ 120 beats/min (bpm) with increase from baseline of ≥ 15 bpm; Weight (kg) increase from baseline of ≥ 10%; Body temperature(°C) ≥ 37.5°C). Clinically notable low values: Systolic blood pressure (SBP): ≤ 90 mmHg with decrease from baseline of ≥ 20 mmHg; Diastolic blood pressure (DBP) : ≤ 50 mmHg with decrease from baseline of ≥ 15 mmHg; Heart rate: ≤ 50 bpm with decrease from baseline of ≥ 15 bpm; Weight: ≥ 20% decrease from baseline; Body temperature \[°C\]: ≤ 36 °C. Number of participants with clinically notable abnormalities in vital signs was reported.
Outcome measures
| Measure |
Encorafenib
n=3 Participants
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Notable or Abnormal Changes in Vital Signs From Baseline of Vital Sign Examinations.
Clinically notable elevated value: SBP : ≥160 mmHg and an increase ≥ 20 mmHg from baseline
|
1 Participants
|
|
Notable or Abnormal Changes in Vital Signs From Baseline of Vital Sign Examinations.
Clinically notable elevated values: DBP: ≥ 100 mmHg and an increase ≥ 15 mmHg from baseline
|
1 Participants
|
|
Notable or Abnormal Changes in Vital Signs From Baseline of Vital Sign Examinations.
Clinically notable elevated values: Pulse rate: ≥ 120 bpm with increase from baseline of ≥15 bpm
|
1 Participants
|
|
Notable or Abnormal Changes in Vital Signs From Baseline of Vital Sign Examinations.
Clinically notable elevated values: Weight: increase from baseline of ≥ 10%
|
0 Participants
|
|
Notable or Abnormal Changes in Vital Signs From Baseline of Vital Sign Examinations.
Clinically notable elevated values: Body temperature [C]: ≥ 37.5 C
|
0 Participants
|
|
Notable or Abnormal Changes in Vital Signs From Baseline of Vital Sign Examinations.
Clinically notable low values: SBP: ≤ 90 mmHg with decrease from baseline of ≥ 20 mmHg
|
0 Participants
|
|
Notable or Abnormal Changes in Vital Signs From Baseline of Vital Sign Examinations.
Clinically notable low values: DBP: ≤ 50 mmHg with decrease from baseline of ≥ 15 mmHg
|
0 Participants
|
|
Notable or Abnormal Changes in Vital Signs From Baseline of Vital Sign Examinations.
Clinically notable low values: Pulse rate: ≤ 50 bpm with decrease from baseline of ≥ 15 bpm
|
0 Participants
|
|
Notable or Abnormal Changes in Vital Signs From Baseline of Vital Sign Examinations.
Clinically notable low values: Weight: ≥ 20% decrease from baseline
|
0 Participants
|
|
Notable or Abnormal Changes in Vital Signs From Baseline of Vital Sign Examinations.
Clinically notable low values: Body temperature [C]: ≤ 36 C
|
1 Participants
|
SECONDARY outcome
Timeframe: Screening (Days -28 to -1), Cycle 1 Day 8, 15 and 22, Day 1 of each subsequent even cycle, and the end of treatment visit, approximately up to 6 months. Each cycle was 28 days.Population: Safety Analysis Set
12-lead ECGs were obtained using an internationally recognized 12-lead cardiograph. Clinically notable ECG values: QT \[millisecond (ms)\] and QT interval (ms) corrected for heart rate using Fridericia's formula (QTcF) intervals (ms): increase from baseline \> 30 ms; increase from baseline \> 60 ms, new \> 450 ms, new \> 480 ms, new \> 500 ms. Heart rate (beats/min): increase from baseline \> 25% to a value \> 100 bpm, decrease from baseline \> 25% and to a value \< 50 bpm. Number of participants with clinically notable values was reported.
Outcome measures
| Measure |
Encorafenib
n=3 Participants
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Notable or Abnormal Changes From Baseline of 12-lead Electrocardiograms (ECGs)
QT Interval : New > 500 ms
|
0 Participants
|
|
Notable or Abnormal Changes From Baseline of 12-lead Electrocardiograms (ECGs)
QT Interval : Increase from baseline > 30 ms
|
1 Participants
|
|
Notable or Abnormal Changes From Baseline of 12-lead Electrocardiograms (ECGs)
QT Interval : Increase from baseline > 60 ms
|
0 Participants
|
|
Notable or Abnormal Changes From Baseline of 12-lead Electrocardiograms (ECGs)
QT Interval : New > 450 ms
|
0 Participants
|
|
Notable or Abnormal Changes From Baseline of 12-lead Electrocardiograms (ECGs)
QT Interval : New > 480 ms
|
0 Participants
|
|
Notable or Abnormal Changes From Baseline of 12-lead Electrocardiograms (ECGs)
QTcF Interval : Increase from baseline > 30 ms
|
1 Participants
|
|
Notable or Abnormal Changes From Baseline of 12-lead Electrocardiograms (ECGs)
QTcF Interval : Increase from baseline > 60 ms
|
0 Participants
|
|
Notable or Abnormal Changes From Baseline of 12-lead Electrocardiograms (ECGs)
QTcF Interval : New > 450 ms
|
0 Participants
|
|
Notable or Abnormal Changes From Baseline of 12-lead Electrocardiograms (ECGs)
QTcF Interval : New > 480 ms
|
0 Participants
|
|
Notable or Abnormal Changes From Baseline of 12-lead Electrocardiograms (ECGs)
QTcF Interval : New > 500 ms
|
0 Participants
|
|
Notable or Abnormal Changes From Baseline of 12-lead Electrocardiograms (ECGs)
Heart rate : Increase from baseline > 25% to a value > 100 bpm
|
1 Participants
|
|
Notable or Abnormal Changes From Baseline of 12-lead Electrocardiograms (ECGs)
Heart rate : Decrease from baseline > 25% and to a value < 50 bpm
|
0 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 through safety follow-up visit (30 days after end of treatment [EOT] visit or 7 days after end EOT visit/last dose if EOT not performed), approximately up to 6 months.Population: Safety Analysis Set
Adverse event of special interest (AESI) were as follows: Cutaneous non-squamous cell carcinoma, cutaneous squamous cell carcinoma, melanomas, facial paresis, uveitis-type events, QT prolongation, non-cutaneous malignancies with RAS mutation. Number of participants with at least one event of any AESI is presented.
Outcome measures
| Measure |
Encorafenib
n=3 Participants
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Occurrence of Targeted Treatment Emergent Adverse Events (TEAEs) of Special Interest
|
0 participants
|
SECONDARY outcome
Timeframe: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle was 28 days.Population: Pharmacokinetics Set
All enrolled participants (n=3) received at least two doses of Encorafenib, did all the planned PK blood collection with associated bioanalytical results and were therefore included in the PK Set. The Area under the curve of Encorafenib was assessed after single and repeated administrations. AUC0-tlast = area under the concentration curve from time 0 to time of last measurable concentration
Outcome measures
| Measure |
Encorafenib
n=3 Participants
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Plasma Pharmacokinetics (PK) of Encorafenib: Area Under the Curve (AUC) After Single and Repeated Administration of Encorafenib
Cycle 1 Day 1 AUC0-tlast
|
21800 h*ng/mL
Standard Deviation 4620
|
|
Plasma Pharmacokinetics (PK) of Encorafenib: Area Under the Curve (AUC) After Single and Repeated Administration of Encorafenib
Cycle 2 Day 1 AUC0-tlast
|
9550 h*ng/mL
Standard Deviation 1750
|
SECONDARY outcome
Timeframe: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle was 28 days.Population: Pharmacokinetic Set
All enrolled participants (n=3) received at least two doses of Encorafenib, did all the planned PK blood collection with associated bioanalytical results and were therefore included in the PK Set. The Area under the curve of Encorafenib metabolite (LHY746) was assessed after single and repeated administrations. AUC0-tlast = area under the concentration curve from time 0 to time of last measurable concentration
Outcome measures
| Measure |
Encorafenib
n=3 Participants
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Plasma Pharmacokinetics (PK) of Encorafenib Metabolite (LHY746): Area Under the Curve (AUC) After Single and Repeated Administration of Encorafenib Metabolite (LHY746)
Cycle 1 Day 1 AUC0-tlast
|
2540 h*ng/mL
Standard Deviation 1150
|
|
Plasma Pharmacokinetics (PK) of Encorafenib Metabolite (LHY746): Area Under the Curve (AUC) After Single and Repeated Administration of Encorafenib Metabolite (LHY746)
Cycle 2 Day 1 AUC0-tlast
|
6020 h*ng/mL
Standard Deviation 3330
|
SECONDARY outcome
Timeframe: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle was 28 days.Population: Pharmacokinetic Set
All enrolled participants (n=3) received at least two doses of encorafenib, did all the planned PK blood collection with associated bioanalytical results and were therefore included in the PK Set. The Maximum Concentration of encorafenib was assessed after single and repeated administrations.
Outcome measures
| Measure |
Encorafenib
n=3 Participants
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Plasma Pharmacokinetics (PK) of Encorafenib: Maximum Concentration (Cmax) After Single and Repeated Administration of Encorafenib
Cycle 1 Day 1 Cmax
|
5590 (ng/mL)
Standard Deviation 351
|
|
Plasma Pharmacokinetics (PK) of Encorafenib: Maximum Concentration (Cmax) After Single and Repeated Administration of Encorafenib
Cycle 2 Day 1 Cmax
|
3630 (ng/mL)
Standard Deviation 1750
|
SECONDARY outcome
Timeframe: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle was 28 days.Population: Pharmacokinetic Set
All enrolled participants (n=3) received at least two doses of encorafenib, did all the planned PK blood collection with associated bioanalytical results and were therefore included in the PK Set. The Maximum Concentration of encorafenib metabolite (LHY746) was assessed after single and repeated administrations.
Outcome measures
| Measure |
Encorafenib
n=3 Participants
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Plasma Pharmacokinetics (PK) of Encorafenib Metabolite (LHY746): Maximum Concentration (Cmax) After Single and Repeated Administration of Encorafenib
Cycle 1 Day 1 Cmax
|
610 ng/mL
Standard Deviation 247
|
|
Plasma Pharmacokinetics (PK) of Encorafenib Metabolite (LHY746): Maximum Concentration (Cmax) After Single and Repeated Administration of Encorafenib
Cycle 2 Day 1 Cmax
|
1420 ng/mL
Standard Deviation 582
|
SECONDARY outcome
Timeframe: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle was 28 days.Population: pharmacokinetic set
All enrolled participants (n=3) received at least two doses of encorafenib, did all the planned PK blood collection with associated bioanalytical results and were therefore included in the PK Set. The Minimum concentration of encorafenib was assessed after single and repeated administrations.
Outcome measures
| Measure |
Encorafenib
n=3 Participants
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Plasma Pharmacokinetics (PK) of Encorafenib: Minimum Concentration (Cmin) After Single and Repeated Administration of Encorafenib
Cycle 1 Day 1 Cmin
|
NA ng/mL
Standard Deviation NA
values were below the limit of quantification
|
|
Plasma Pharmacokinetics (PK) of Encorafenib: Minimum Concentration (Cmin) After Single and Repeated Administration of Encorafenib
Cycle 2 Day 1 Cmin
|
10.5 ng/mL
Standard Deviation 6.76
|
SECONDARY outcome
Timeframe: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle was 28 days.Population: Pharmacokinetic Set
All enrolled participants (n=3) received at least two doses of encorafenib, did all the planned PK blood collection with associated bioanalytical results and were therefore included in the PK Set. The Minimum concentration of encorafenib metabolite (LHY746) was assessed after single and repeated administrations.
Outcome measures
| Measure |
Encorafenib
n=3 Participants
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Plasma Pharmacokinetics (PK) of Encorafenib Metabolite (LHY746): Minimum Concentration (Cmin) After Single and Repeated Administration of Encorafenib
Cycle 1 Day 1 Cmin
|
NA ng/mL
Standard Deviation NA
Values were below the limit of quantification
|
|
Plasma Pharmacokinetics (PK) of Encorafenib Metabolite (LHY746): Minimum Concentration (Cmin) After Single and Repeated Administration of Encorafenib
Cycle 2 Day 1 Cmin
|
109 ng/mL
Standard Deviation 91.7
|
SECONDARY outcome
Timeframe: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle was 28 days.Population: Pharmacokinetic Set
All enrolled participants (n=3) received at least two doses of encorafenib, did all the planned PK blood collection with associated bioanalytical results and were therefore included in the PK Set. The time taken to reach maximum concentration of Encorafenib was assessed after single and repeated administrations.
Outcome measures
| Measure |
Encorafenib
n=3 Participants
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Plasma Pharmacokinetics (PK) of Encorafenib: Time Taken to Reach Maximum Concentration (Tmax) After Single and Repeated Administration of Encorafenib
Cycle 1 Day 1 tmax
|
2.00 hours
Interval 1.0 to 4.03
|
|
Plasma Pharmacokinetics (PK) of Encorafenib: Time Taken to Reach Maximum Concentration (Tmax) After Single and Repeated Administration of Encorafenib
Cycle 2 Day 1 tmax
|
1.00 hours
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle was 28 days.Population: Pharmacokinetic Set
All enrolled participants (n=3) received at least two doses of encorafenib, did all the planned PK blood collection with associated bioanalytical results and were therefore included in the PK Set. The time taken to reach maximum concentration of Encorafenib Metabolite (LHY746) was assessed after single and repeated administrations.
Outcome measures
| Measure |
Encorafenib
n=3 Participants
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Plasma Pharmacokinetics (PK) of Encorafenib Metabolite (LHY746): Time Taken to Reach Maximum Concentration (Tmax) After Single and Repeated Administration of Encorafenib Metabolite (LHY746)
Cycle 1 Day 1 tmax
|
5.98 hours
Interval 5.92 to 6.0
|
|
Plasma Pharmacokinetics (PK) of Encorafenib Metabolite (LHY746): Time Taken to Reach Maximum Concentration (Tmax) After Single and Repeated Administration of Encorafenib Metabolite (LHY746)
Cycle 2 Day 1 tmax
|
2.00 hours
Interval 1.97 to 4.0
|
SECONDARY outcome
Timeframe: at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle was 28 days.Population: Pharmacokinetics Set
All enrolled participants (n=3) received at least two doses of Encorafenib, did all the planned PK blood collection with associated bioanalytical results and were therefore included in the PK Set. The ARAUC of Encorafenib was assessed after single and repeated administrations. ARAUC = Observed accumulation ratio based on AUC0-6
Outcome measures
| Measure |
Encorafenib
n=3 Participants
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Plasma Pharmacokinetics (PK) of Encorafenib: ARAUC After Single and Repeated Administration of Encorafenib
|
0.440 ratio
Geometric Coefficient of Variation 40.2
|
SECONDARY outcome
Timeframe: at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle was 28 days.Population: Pharmacokinetics Set
All enrolled participants (n=3) received at least two doses of encorafenib, did all the planned PK blood collection with associated bioanalytical results and were therefore included in the PK Set. The ARAUC of encorafenib metabolite (LHY746) was assessed after single and repeated administrations. ARAUC = Observed accumulation ratio based on AUC0-6
Outcome measures
| Measure |
Encorafenib
n=3 Participants
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Plasma Pharmacokinetics (PK) of Encorafenib Metabolite (LHY746): ARAUC After Single and Repeated Administration of Encorafenib Metabolite (LHY746)
|
2.27 ratio
Geometric Coefficient of Variation 18.2
|
SECONDARY outcome
Timeframe: First day of treatment (Cycle 1 Day 1) and at steady state after 1 month treatment (Cycle 2 Day 1). Each cycle was 28 days.Population: Pharmacokinetics Set
All enrolled participants (n=3) received at least two doses of encorafenib, did all the planned PK blood collection with associated bioanalytical results and were therefore included in the PK Set. The MRAUC of encorafenib metabolite (LHY746) was assessed after single and repeated administrations. MRAUC = Metabolite Parent ratio based on AUC0-6
Outcome measures
| Measure |
Encorafenib
n=3 Participants
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Plasma Pharmacokinetics (PK) of Encorafenib Metabolite (LHY746): MRAUC After Single and Repeated Administration of Encorafenib Metabolite (LHY746)
Cycle 1 Day 1
|
0.141 ratio
Geometric Coefficient of Variation 53.1
|
|
Plasma Pharmacokinetics (PK) of Encorafenib Metabolite (LHY746): MRAUC After Single and Repeated Administration of Encorafenib Metabolite (LHY746)
Cycle 2 Day 1
|
0.730 ratio
Geometric Coefficient of Variation 41.3
|
Adverse Events
Encorafenib
Serious adverse events
| Measure |
Encorafenib
n=3 participants at risk
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
33.3%
1/3 • Number of events 1 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic naevus
|
33.3%
1/3 • Number of events 2 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
Other adverse events
| Measure |
Encorafenib
n=3 participants at risk
Encorafenib hard capsule was orally administered. A fixed-flat dose of 300 mg (4 x 75 mg) Per Oral (PO) encorafenib was administered once-daily (QD).
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Number of events 2 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Number of events 3 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Investigations
Neutrophil count increased
|
100.0%
3/3 • Number of events 5 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Investigations
Blood cholesterol increased
|
33.3%
1/3 • Number of events 1 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Investigations
Blood glucose increased
|
33.3%
1/3 • Number of events 1 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Investigations
C-reactive protein increased
|
33.3%
1/3 • Number of events 1 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Investigations
Coagulation time prolonged
|
33.3%
1/3 • Number of events 1 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Investigations
Lipase increased
|
33.3%
1/3 • Number of events 1 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Investigations
Platelet count increased
|
33.3%
1/3 • Number of events 1 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Investigations
Urinary occult blood
|
33.3%
1/3 • Number of events 2 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Investigations
White blood cell count increased
|
33.3%
1/3 • Number of events 1 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Renal and urinary disorders
Proteinuria
|
100.0%
3/3 • Number of events 3 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
33.3%
1/3 • Number of events 1 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
66.7%
2/3 • Number of events 3 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
33.3%
1/3 • Number of events 2 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
33.3%
1/3 • Number of events 1 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Number of events 1 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
33.3%
1/3 • Number of events 1 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
33.3%
1/3 • Number of events 1 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
66.7%
2/3 • Number of events 3 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Number of events 2 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Infections and infestations
Subcutaneous abscess
|
33.3%
1/3 • Number of events 2 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
33.3%
1/3 • Number of events 2 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
33.3%
1/3 • Number of events 1 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
33.3%
1/3 • Number of events 1 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Number of events 1 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
33.3%
1/3 • Number of events 1 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Nervous system disorders
Neuritis
|
33.3%
1/3 • Number of events 1 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
33.3%
1/3 • Number of events 1 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 1 • All adverse events were collected for approximately 6 months, from when the participant first provided informed consent until the 30-day safety follow-up visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Except for the release of SAE of study drug/product defects of the institution, institution and/or investigator shall promptly notify sponsor of the content to be released before releasing other research information and obtain sponsor's consent. If there is no response from sponsor within 60 working days after issuance or specific reason for disagreement and modification suggestions are not listed in the response, it shall be deemed that sponsor agrees.
- Publication restrictions are in place
Restriction type: OTHER