Trial Outcomes & Findings for Phase 1/2 Study of the ERK1/2 Inhibitor BVD-523 in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndromes (NCT NCT02296242)

Last Updated: 2019-01-29

Results Overview

DLT defined using CTCAE v.4.03. All toxicities were considered to be related to BVD523 if not definitively explained by underlying disease, intercurrent illness, or con meds.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

53 participants

Primary outcome timeframe

In the first 21 days of treatment

Results posted on

2019-01-29

Participant Flow

Up to 6 study centers were to enroll up to 20 AML or MDS patients for Part 1 (dose-escalation) and 40 evaluable patients (≤ 20 RAS mutant positive AML or MDS patients and ≤ 20 RAS mutant negative AML or MDS patients) for Part 2 (cohort expansion). The last patient completed in May 2017.

Participant milestones

Participant milestones
Measure	Dose-escalation 300mg b.i.d. Cohort Patients received 300mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Dose-escalation 600mg b.i.d. Cohort Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Dose-escalation 750mg b.i.d. Cohort Patients received 750mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Cohort-expansion RAS(+) Group Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs.	Cohort-expansion RAS(-) Group Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs.
Overall Study STARTED	5	6	7	14	21
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	5	6	7	14	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose-escalation 300mg b.i.d. Cohort Patients received 300mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Dose-escalation 600mg b.i.d. Cohort Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Dose-escalation 750mg b.i.d. Cohort Patients received 750mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Cohort-expansion RAS(+) Group Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs.	Cohort-expansion RAS(-) Group Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs.
Overall Study Death	1	1	1	1	1
Overall Study Withdrawal by Subject	0	0	1	1	3
Overall Study Disease Progression	1	3	2	8	11
Overall Study Unacceptable Toxicity	0	0	0	0	1
Overall Study Patient Condition Changed	0	0	2	0	1
Overall Study At Least 3 Drug Interruptions	0	0	1	1	1
Overall Study Lost to Follow-up	1	0	0	0	0
Overall Study Need for Hydroxyurea	2	0	0	0	0
Overall Study Screened for Other Protocol	0	1	0	0	0
Overall Study Physician Decision	0	1	0	1	0
Overall Study Alternative Treatment	0	0	0	1	0
Overall Study Adverse Event	0	0	0	1	0
Overall Study Lack of Efficacy	0	0	0	0	3

Baseline Characteristics

Phase 1/2 Study of the ERK1/2 Inhibitor BVD-523 in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndromes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose-escalation 300mg b.i.d. Cohort n=5 Participants Patients received 300mg oral doses of BVD-523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Dose-escalation 600mg b.i.d. Cohort n=6 Participants Patients received 600mg oral doses of BVD-523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Dose-escalation 750mg b.i.d. Cohort n=7 Participants Patients received 750mg oral doses of BVD-523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Cohort-expansion RAS(+) Group n=14 Participants Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs.	Cohort-expansion RAS(-) Group n=21 Participants Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs.	Total n=53 Participants Total of all reporting groups
Region of Enrollment United States	5 participants n=93 Participants	6 participants n=4 Participants	7 participants n=27 Participants	14 participants n=483 Participants	21 participants n=36 Participants	53 participants n=10 Participants
Age, Continuous	71.6 years STANDARD_DEVIATION 9.21 • n=93 Participants	58.7 years STANDARD_DEVIATION 19.18 • n=4 Participants	65.6 years STANDARD_DEVIATION 18.11 • n=27 Participants	70.6 years STANDARD_DEVIATION 10.08 • n=483 Participants	66.0 years STANDARD_DEVIATION 15.66 • n=36 Participants	66.8 years STANDARD_DEVIATION 14.62 • n=10 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants	5 Participants n=483 Participants	8 Participants n=36 Participants	20 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	5 Participants n=4 Participants	3 Participants n=27 Participants	9 Participants n=483 Participants	13 Participants n=36 Participants	33 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants	4 Participants n=483 Participants	1 Participants n=36 Participants	7 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=93 Participants	6 Participants n=4 Participants	5 Participants n=27 Participants	10 Participants n=483 Participants	20 Participants n=36 Participants	46 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	3 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	2 Participants n=36 Participants	3 Participants n=10 Participants
Race (NIH/OMB) White	5 Participants n=93 Participants	4 Participants n=4 Participants	4 Participants n=27 Participants	11 Participants n=483 Participants	17 Participants n=36 Participants	41 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	3 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants	1 Participants n=36 Participants	3 Participants n=10 Participants

PRIMARY outcome

Timeframe: In the first 21 days of treatment

DLT defined using CTCAE v.4.03. All toxicities were considered to be related to BVD523 if not definitively explained by underlying disease, intercurrent illness, or con meds.

Outcome measures

Outcome measures
Measure	Dose-escalation 300mg b.i.d. Cohort n=5 Participants Patients received 300mg oral doses of BVD-523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Dose-escalation 600mg b.i.d. Cohort n=6 Participants Patients received 600mg oral doses of BVD-523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Dose-escalation 750mg b.i.d. Cohort n=7 Participants Patients received 750mg oral doses of BVD-523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Cohort-expansion RAS(+) Group n=14 Participants Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs.	Cohort-expansion RAS(-) Group n=21 Participants Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs.
Number of Patients With Dose Limiting Toxicities Any BVD-523-related DLTs? · Yes	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Patients With Dose Limiting Toxicities Any BVD-523-related DLTs? · No	5 Participants	6 Participants	5 Participants	14 Participants	21 Participants
Number of Patients With Dose Limiting Toxicities Related tox causing tx delay >4 days (rash >7days) · Yes	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Number of Patients With Dose Limiting Toxicities Related tox causing tx delay >4 days (rash >7days) · No	5 Participants	6 Participants	5 Participants	14 Participants	21 Participants

PRIMARY outcome

Timeframe: Samples will be collected on or about Day 22 of the protocol

Population: The cohort-expansion patients were not separated by RAS status for the purposes of this assessment. Two patients in the cohort expansion had to have their dose reduced to 300mg BID and were analyzed separately (Cmax 1000 \& 1340 ng/mL on Day 22). 00 = not calculated (only 1 evaluable patient).

The PK population consisted of patients who received at least one dose of BVD-523 and had evaluable PK data in plasma.

Outcome measures

Outcome measures
Measure	Dose-escalation 300mg b.i.d. Cohort n=4 Participants Patients received 300mg oral doses of BVD-523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Dose-escalation 600mg b.i.d. Cohort n=1 Participants Patients received 600mg oral doses of BVD-523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Dose-escalation 750mg b.i.d. Cohort n=4 Participants Patients received 750mg oral doses of BVD-523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Cohort-expansion RAS(+) Group n=12 Participants Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs.	Cohort-expansion RAS(-) Group Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs.
Steady-state Plasma Concentration of BVD-523 and Selected Metabolites Over 12 Hours 0 hr (predose)	455 ng/mL Standard Deviation 212	1860 ng/mL Standard Deviation 00	2080 ng/mL Standard Deviation 1310	1540 ng/mL Standard Deviation 800	—
Steady-state Plasma Concentration of BVD-523 and Selected Metabolites Over 12 Hours 0.5 hr	428 ng/mL Standard Deviation 193	1670 ng/mL Standard Deviation 00	2020 ng/mL Standard Deviation 1240	1280 ng/mL Standard Deviation 767	—
Steady-state Plasma Concentration of BVD-523 and Selected Metabolites Over 12 Hours 1 hr	506 ng/mL Standard Deviation 159	1590 ng/mL Standard Deviation 00	2130 ng/mL Standard Deviation 693	1440 ng/mL Standard Deviation 698	—
Steady-state Plasma Concentration of BVD-523 and Selected Metabolites Over 12 Hours 2 hr	1300 ng/mL Standard Deviation 1090	1760 ng/mL Standard Deviation 00	2220 ng/mL Standard Deviation 1500	1790 ng/mL Standard Deviation 776	—
Steady-state Plasma Concentration of BVD-523 and Selected Metabolites Over 12 Hours 4 hr	1150 ng/mL Standard Deviation 555	1520 ng/mL Standard Deviation 00	2670 ng/mL Standard Deviation 1490	1800 ng/mL Standard Deviation 914	—
Steady-state Plasma Concentration of BVD-523 and Selected Metabolites Over 12 Hours 6 hr	728 ng/mL Standard Deviation 435	1510 ng/mL Standard Deviation 00	2360 ng/mL Standard Deviation 1510	1400 ng/mL Standard Deviation 741	—
Steady-state Plasma Concentration of BVD-523 and Selected Metabolites Over 12 Hours 8 hr	480 ng/mL Standard Deviation 301	1100 ng/mL Standard Deviation 00	1870 ng/mL Standard Deviation 1150	1140 ng/mL Standard Deviation 623	—
Steady-state Plasma Concentration of BVD-523 and Selected Metabolites Over 12 Hours 12 hr	528 ng/mL Standard Deviation 364	902 ng/mL Standard Deviation 00	1650 ng/mL Standard Deviation 1070	974 ng/mL Standard Deviation 567	—

SECONDARY outcome

Timeframe: Until patient discontinuation; ~24 months on average

Assessments were made via bone marrow biopsies using the International Working Group 2003 and 2006 criteria for AML or MDS, respectively. Bone marrow assessments (aspiration or biopsy, cytogenetics) were collected prior to therapy on Day 1 and Day 22, every 2 cycles thereafter, as well as at the final study visit if discontinuation was not due to disease progression. Some patients were unable to have bone marrow assessments taken at any or all of the time points. Shown is best response across all time points. Less than partial remission/response (\<PR), partial remission/response (PR), complete remission/response with incomplete platelet recovery (CRp), or complete remission/response (CR).

Outcome measures

Outcome measures
Measure	Dose-escalation 300mg b.i.d. Cohort n=20 Response(s) Patients received 300mg oral doses of BVD-523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Dose-escalation 600mg b.i.d. Cohort n=26 Response(s) Patients received 600mg oral doses of BVD-523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Dose-escalation 750mg b.i.d. Cohort Patients received 750mg oral doses of BVD-523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Cohort-expansion RAS(+) Group Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs.	Cohort-expansion RAS(-) Group Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs.
Clinical Evidence of Cancer Response in Bone Marrow Biopsies < PR	20 Response(s)	22 Response(s)	—	—	—
Clinical Evidence of Cancer Response in Bone Marrow Biopsies PR	0 Response(s)	1 Response(s)	—	—	—
Clinical Evidence of Cancer Response in Bone Marrow Biopsies CRp	0 Response(s)	2 Response(s)	—	—	—
Clinical Evidence of Cancer Response in Bone Marrow Biopsies CR	0 Response(s)	1 Response(s)	—	—	—

SECONDARY outcome

Timeframe: Until patient discontinuation; ~24 months on average

Population: Part 1: \<PR for all data points. Part 2: One patient had a CRp at 2 visits. One patient had a CR.

Assessments were made via bone marrow biopsies using the International Working Group 2003 and 2006 criteria for AML or MDS, respectively. Progression-free survival (PFS) and duration of response (DOR) of AML or MDS patients was assessed in patients treated with BVD-523 that achieved complete remission/response (CR) or complete remission/response with incomplete platelet recovery (CRp). \<PR = less than partial remission/response. Shown is the duration (number of days) of CR or CRp response for the 2 patients in part 2 that obtained this level of response.

Outcome measures

Outcome measures
Measure	Dose-escalation 300mg b.i.d. Cohort n=14 Participants Patients received 300mg oral doses of BVD-523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Dose-escalation 600mg b.i.d. Cohort n=21 Participants Patients received 600mg oral doses of BVD-523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Dose-escalation 750mg b.i.d. Cohort Patients received 750mg oral doses of BVD-523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Cohort-expansion RAS(+) Group Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs.	Cohort-expansion RAS(-) Group Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs.
Duration of Disease Control in Patients That Respond	64 Days	5 Days	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Patients will be evaluated at baseline and on or about Day 22 of the protocol

Population: Data was not collected/reported for patient at time point or patient did not start a second cycle.

Multiple biomarkers intended to demonstrate inhibition of the molecular target, and mechanism of action were investigated from blood and/or bone marrow aspirate samples. Phosphorylation of ERK enzyme substrate proteins (e.g. RSK1 and RSK2 genes) were measured. Additional biomarkers, including PBMCs and/or DNA sequence analysis, were identified and measured as appropriate. Measurements were by ELISA. The pharmacodynamics (PD) population was defined as all patients who received at least one dose of study drug and had sufficient, valid PD samples to estimate key parameters for at least one of the days of sampling.

Outcome measures

Outcome measures
Measure	Dose-escalation 300mg b.i.d. Cohort n=18 Participants Patients received 300mg oral doses of BVD-523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Dose-escalation 600mg b.i.d. Cohort n=35 Participants Patients received 600mg oral doses of BVD-523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Dose-escalation 750mg b.i.d. Cohort Patients received 750mg oral doses of BVD-523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Cohort-expansion RAS(+) Group Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs.	Cohort-expansion RAS(-) Group Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs.
Pharmacodynamic Results of Inhibition (%) of Molecular Target (ERK Pathway) Assessed by Blood and Tissue Analyses. Baseline (Cycle 1, Day 1) Pre-Dose	0.0 Percent (%) Inhibition Standard Deviation 0.00	0.0 Percent (%) Inhibition Standard Deviation 0.00	—	—	—
Pharmacodynamic Results of Inhibition (%) of Molecular Target (ERK Pathway) Assessed by Blood and Tissue Analyses. Baseline (Cycle 1, Day 1) 4 Hours Post-Dose	78.1 Percent (%) Inhibition Standard Deviation 30.86	56.9 Percent (%) Inhibition Standard Deviation 177.46	—	—	—
Pharmacodynamic Results of Inhibition (%) of Molecular Target (ERK Pathway) Assessed by Blood and Tissue Analyses. Cycle 2, Day 1 Pre-Dose	73.6 Percent (%) Inhibition Standard Deviation 33.55	71.5 Percent (%) Inhibition Standard Deviation 58.36	—	—	—
Pharmacodynamic Results of Inhibition (%) of Molecular Target (ERK Pathway) Assessed by Blood and Tissue Analyses. Cycle 2, Day 1 - 4 Hours Post-Dose	75.9 Percent (%) Inhibition Standard Deviation 32.75	83.0 Percent (%) Inhibition Standard Deviation 41.82	—	—	—

Adverse Events

Dose-escalation 300mg b.i.d. Cohort

Serious events: 5 serious events

Other events: 2 other events

Deaths: 4 deaths

Dose-escalation 600mg b.i.d. Cohort

Serious events: 4 serious events

Other events: 1 other events

Deaths: 2 deaths

Dose-escalation 750mg b.i.d. Cohort

Serious events: 6 serious events

Other events: 6 other events

Deaths: 4 deaths

Cohort-expansion RAS(+) Group

Serious events: 10 serious events

Other events: 9 other events

Deaths: 2 deaths

Cohort-expansion RAS(-) Group

Serious events: 18 serious events

Other events: 11 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Dose-escalation 300mg b.i.d. Cohort n=5 participants at risk Patients received 300mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Dose-escalation 600mg b.i.d. Cohort n=6 participants at risk Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Dose-escalation 750mg b.i.d. Cohort n=7 participants at risk Patients received 750mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Cohort-expansion RAS(+) Group n=14 participants at risk Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs.	Cohort-expansion RAS(-) Group n=21 participants at risk Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs.
Blood and lymphatic system disorders Febrile neutropenia	20.0% 1/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	28.6% 2/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	21.4% 3/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	28.6% 6/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Blood and lymphatic system disorders Leukocytosis	20.0% 1/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 2/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	4.8% 1/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Diarrhea	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	33.3% 2/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 2/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	4.8% 1/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Gastrointestinal hemorrhage	20.0% 1/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	33.3% 2/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 1/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	9.5% 2/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
General disorders Death	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	4.8% 1/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Disease progression	20.0% 1/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	16.7% 1/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 1/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	9.5% 2/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Pyrexia	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 2/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 3/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Infections and infestations Bacteremia	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 3/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Infections and infestations Pneumonia	60.0% 3/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 1/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	19.0% 4/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Infections and infestations Sepsis	20.0% 1/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	28.6% 2/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	9.5% 2/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Metabolism and nutrition disorders Dehydration	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 2/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Renal and urinary disorders Renal failure acute	20.0% 1/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	28.6% 2/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Vascular disorders Hypotension	20.0% 1/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	9.5% 2/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.

Other adverse events

Other adverse events
Measure	Dose-escalation 300mg b.i.d. Cohort n=5 participants at risk Patients received 300mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Dose-escalation 600mg b.i.d. Cohort n=6 participants at risk Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Dose-escalation 750mg b.i.d. Cohort n=7 participants at risk Patients received 750mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion was noted. Treatment cycles occurred consecutively without interruption, except when necessary to manage AEs. All dose-escalation decisions were based on Cycle 1 safety data and doses were not escalated unless the patients receiving the highest current dose had been observed for at least 21 days (1 cycle).	Cohort-expansion RAS(+) Group n=14 participants at risk Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs.	Cohort-expansion RAS(-) Group n=21 participants at risk Patients received 600mg oral doses of BVD 523 b.i.d. for 21 days (a "Cycle"). Patients received doses of BVD-523 until disease progression, unacceptable toxicity, or another withdrawal criterion was met. Treatment cycles occurred consecutively without interruption except when necessary to manage AEs.
Eye disorders Vision Blurred	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 1/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Diarrhea	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	28.6% 2/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	35.7% 5/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	28.6% 6/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Gastroesophageal Reflux Disease	20.0% 1/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 1/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	4.8% 1/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Nausea	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	42.9% 3/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 2/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	23.8% 5/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Oral Mucosal Eruption	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 1/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Vomiting	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	28.6% 2/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 3/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
General disorders Fatigue	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	28.6% 2/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	4.8% 1/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 1/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Infections and infestations Sepsis	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 1/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Investigations Blood Creatinine Increased	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 1/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	28.6% 4/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	9.5% 2/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Investigations Liver Function Test Abnormal	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 1/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	16.7% 1/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 1/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 1/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Renal and urinary disorders Renal Failure Acute	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 1/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Skin and subcutaneous tissue disorders Eczema	20.0% 1/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Skin and subcutaneous tissue disorders Erythema Multiforme	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 1/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Skin and subcutaneous tissue disorders Pruritus Generalized	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	28.6% 2/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	4.8% 1/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Skin and subcutaneous tissue disorders Rash	20.0% 1/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 1/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	9.5% 2/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	4.8% 1/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	4.8% 1/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Eye disorders Lacrimation Increased	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 2/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Abdominal Pain	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Constipation	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Dyspepsia	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	4.8% 1/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
General disorders Asthenia	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	4.8% 1/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
General disorders Oedema Peripheral	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	14.3% 2/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
General disorders Pyrexia	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	9.5% 2/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Infections and infestations Diverticulitis	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	4.8% 1/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Injury, poisoning and procedural complications Subdural Hematoma	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	4.8% 1/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Investigations Alanine Aminotransferase Increased	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	4.8% 1/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Investigations Aspartate Aminotransferase Increased	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Investigations Electrocardiogram QT Prolonged	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	4.8% 1/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Investigations Neutrophil Count Decreased	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Investigations Platelet Count Decreased	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Investigations Weight Decreased	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Metabolism and nutrition disorders Dehydration	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	4.8% 1/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	4.8% 1/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Nervous system disorders Dizziness	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	4.8% 1/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Nervous system disorders Headache	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Nervous system disorders Presyncope	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Psychiatric disorders Hallucination	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Renal and urinary disorders Acute Prerenal Failure	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	4.8% 1/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Skin and subcutaneous tissue disorders Dry Skin	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	4.8% 1/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Skin and subcutaneous tissue disorders Rash Macular	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	4.8% 1/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Vascular disorders Hypotension	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.
Vascular disorders Orthostatic Hypotension	0.00% 0/5 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/6 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/7 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	7.1% 1/14 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.	0.00% 0/21 • A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of BVD-523 from initiation of BVD-523 initiation until 30 calendar days following the last administration of BVD-523, whether or not the AE was considered related to study drug. TEAEs were monitored/assessed until 30 calendar days following the last administration of BVD-523. TEAEs were analyzed for the safety population. Analyses were performed for any TEAEs by SOC and PT. Patients were counted only once if they had more than one TEAE within a SOC or experienced a PT more than once. A patient who reported multiple AEs that map to a common PT or SOC is counted only once for that PT or SOC at the highest severity reported and at the greatest relationship to study drug. AEs were collected/assessed at each study visit.

Additional Information

Dean Welsch, PhD

BioMed Valley Discoveries

Phone: 8163898831

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place