Trial Outcomes & Findings for Study of Ulixertinib for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations (NCT NCT04488003)

NCT ID: NCT04488003

Last Updated: 2024-06-04

Results Overview

ORR will be defined as the percentage of patients achieving a Best Overall Response (BOR) of confirmed Complete Response (CR) and/or Partial Response (PR). Patients will be evaluated at baseline \& at periodic follow-up visits through the time their participation in the study is complete.The best responses will occur at different time points for each patient.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 104 participants
• Primary outcome timeframe: Up to 25 months
• Results posted on: 2024-06-04

Participant Flow

The study was conducted at 24 clinical sites in the USA. Enrollment took place between January 2021 and December 2022.

Participant milestones

Measure	Part A: Ulixertinib Oral, 600 mg, twice daily, for 28-days in each treatment cycle Ulixertinib: Oral, 600 mg, twice daily, for 28-days in each treatment cycle	Part B: Ulixertinib Oral, 600 mg, twice daily, for 28-days in each treatment cycle Ulixertinib: Oral, 600 mg, twice daily, for 28-days in each treatment cycle	Part B: Physician's Choice of Treatment Physician's choice will be restricted to two approved (not off-label) treatments for each tumor histology (agents targeting BRAF or MEK kinases and experimental agents are not permitted as physician choice). If a patient progresses on physician's choice of treatment, crossover to the ulixertinib arm is permitted. Physician's Choice: Physician's choice will be restricted to two approved (not off-label) treatments for each tumor histology (agents targeting BRAF or MEK kinases and experimental agents are not permitted as physician choice)).
Assessed for Eligibility STARTED	104	0	0
Assessed for Eligibility COMPLETED	77	0	0
Assessed for Eligibility NOT COMPLETED	27	0	0
Allocated to Treatment STARTED	77	0	0
Allocated to Treatment COMPLETED	0	0	0
Allocated to Treatment NOT COMPLETED	77	0	0

Reasons for withdrawal

Measure	Part A: Ulixertinib Oral, 600 mg, twice daily, for 28-days in each treatment cycle Ulixertinib: Oral, 600 mg, twice daily, for 28-days in each treatment cycle	Part B: Ulixertinib Oral, 600 mg, twice daily, for 28-days in each treatment cycle Ulixertinib: Oral, 600 mg, twice daily, for 28-days in each treatment cycle	Part B: Physician's Choice of Treatment Physician's choice will be restricted to two approved (not off-label) treatments for each tumor histology (agents targeting BRAF or MEK kinases and experimental agents are not permitted as physician choice). If a patient progresses on physician's choice of treatment, crossover to the ulixertinib arm is permitted. Physician's Choice: Physician's choice will be restricted to two approved (not off-label) treatments for each tumor histology (agents targeting BRAF or MEK kinases and experimental agents are not permitted as physician choice)).
Assessed for Eligibility Screen Failure	24	0	0
Assessed for Eligibility Adverse Event	1	0	0
Assessed for Eligibility Death	1	0	0
Assessed for Eligibility Physician Decision	1	0	0
Allocated to Treatment Progressive Disease	51	0	0
Allocated to Treatment Withdrawal by Subject	7	0	0
Allocated to Treatment Adverse Event	6	0	0
Allocated to Treatment Other	5	0	0
Allocated to Treatment Physician Decision	4	0	0
Allocated to Treatment Death	4	0	0

Baseline Characteristics

Study of Ulixertinib for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations

Baseline characteristics by cohort

Measure	Part A: Ulixertinib n=77 Participants Oral, 600 mg, twice daily, for 28-days in each treatment cycle Ulixertinib: Oral, 600 mg, twice daily, for 28-days in each treatment cycle
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=5 Participants
Age, Categorical >=65 years	28 Participants n=5 Participants
Age, Continuous	59.9 years STANDARD_DEVIATION 12.03 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	73 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	70 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	77 participants n=5 Participants
ECOG Performance at Baseline ECOG 0	23 Participants n=5 Participants
ECOG Performance at Baseline ECOG 1	50 Participants n=5 Participants
ECOG Performance at Baseline ECOG 2	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 25 months

ORR will be defined as the percentage of patients achieving a Best Overall Response (BOR) of confirmed Complete Response (CR) and/or Partial Response (PR). Patients will be evaluated at baseline & at periodic follow-up visits through the time their participation in the study is complete.The best responses will occur at different time points for each patient.

Outcome measures

Measure	Part A: Ulixertinib n=77 Participants Oral, 600 mg, twice daily, for 28-days in each treatment cycle Ulixertinib: Oral, 600 mg, twice daily, for 28-days in each treatment cycle
Part A: Overall Response Rate (ORR) According to RECIST 1.1	0 Participants

SECONDARY outcome

Timeframe: 18 months

PFS will be defined as time from first day of study drug to disease progression or death. Patients with no event will be censored at the last available tumor assessment. This analysis will be based on investigator assessment.

Outcome measures

Measure	Part A: Ulixertinib n=66 Participants Oral, 600 mg, twice daily, for 28-days in each treatment cycle Ulixertinib: Oral, 600 mg, twice daily, for 28-days in each treatment cycle
Part A: Progression Free Survival (PFS) According to RECIST 1.1	1.5 months Interval 1.0 to 2.5

SECONDARY outcome

Timeframe: 18 months

OS will be defined as time from first day of study drug to death. Patients with no event will be censored at the last date the patient is known to be alive.

Outcome measures

Measure	Part A: Ulixertinib n=50 Participants Oral, 600 mg, twice daily, for 28-days in each treatment cycle Ulixertinib: Oral, 600 mg, twice daily, for 28-days in each treatment cycle
Part A: Overall Survival (OS) According to RECIST 1.1	5.2 months Interval 3.8 to 7.0

SECONDARY outcome

Timeframe: Single time point drawn at Visit 4/approximately day 15 (or whenever the patient reaches steady state).

Single time point taken prior to taking study drug (trough) at steady state. Steady state is defined as patients who have received at least 5 days, or 10 consecutive doses, of study drug.

Outcome measures

Measure	Part A: Ulixertinib n=40 Participants Oral, 600 mg, twice daily, for 28-days in each treatment cycle Ulixertinib: Oral, 600 mg, twice daily, for 28-days in each treatment cycle
Part A: Pharmacokinetic Concentration of BVD-523 at Steady State	1136.39 ng/mL Standard Deviation 689.538

Adverse Events

Part A: Ulixertinib

Serious events: 41 serious events

Other events: 76 other events

Deaths: 52 deaths

Serious adverse events

Measure	Part A: Ulixertinib n=77 participants at risk Oral, 600 mg, twice daily, for 28-days in each treatment cycle Ulixertinib: Oral, 600 mg, twice daily, for 28-days in each treatment cycle
General disorders Disease progression	18.2% 14/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
General disorders Asthenia	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
General disorders Pyrexia	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Infections and infestations Pneumonia	2.6% 2/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Infections and infestations Anorectal infection bacterial	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Infections and infestations Cystitis	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Infections and infestations Kidney infection	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Infections and infestations Pyelonephritis	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Infections and infestations Rectal abscess	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Infections and infestations Sepsis	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Infections and infestations Urinary tract infection	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Infections and infestations Urosepsis	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.6% 2/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.6% 2/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.6% 2/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Respiratory, thoracic and mediastinal disorders Cough	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Malignant gastrointestinal obstruction	2.6% 2/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Abdominal pain	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Abdominal pain lower	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Vomiting	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Metabolism and nutrition disorders Hyponatraemia	2.6% 2/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Metabolism and nutrition disorders Dehydration	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Metabolism and nutrition disorders Hypokalaemia	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Musculoskeletal and connective tissue disorders Muscular weakness	2.6% 2/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Musculoskeletal and connective tissue disorders Back pain	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Musculoskeletal and connective tissue disorders Pain in extremity	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Nervous system disorders Syncope	2.6% 2/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Nervous system disorders Cauda equina syndrome	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Nervous system disorders Dizziness	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Renal and urinary disorders Acute kidney injury	2.6% 2/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Renal and urinary disorders Renal failure	2.6% 2/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Renal and urinary disorders Postrenal failure	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Hepatobiliary disorders Gallbladder rupture	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Hepatobiliary disorders Hyperbilirubinaemia	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Hepatobiliary disorders Portal vein thrombosis	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Investigations Alanine aminotransferase increased	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Investigations Aspartate aminotransferase increased	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Investigations Blood bilirubin increased	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Investigations Blood creatinine increased	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Cardiac disorders Atrial fibrillation	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Cardiac disorders Cardiac failure	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Psychiatric disorders Mental status changes	2.6% 2/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	2.6% 2/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Skin and subcutaneous tissue disorders Rash	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Blood and lymphatic system disorders Thrombocytopenia	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Immune system disorders Hypersensitivity	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Injury, poisoning and procedural complications Femur fracture	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Vascular disorders Hypotension	1.3% 1/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.

Other adverse events

Measure	Part A: Ulixertinib n=77 participants at risk Oral, 600 mg, twice daily, for 28-days in each treatment cycle Ulixertinib: Oral, 600 mg, twice daily, for 28-days in each treatment cycle
Gastrointestinal disorders Diarrhoea	45.5% 35/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Nausea	45.5% 35/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Vomiting	23.4% 18/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Constipation	19.5% 15/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Abdominal pain	14.3% 11/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Stomatitis	7.8% 6/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Dry mouth	6.5% 5/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Gastrointestinal disorders Gastrooesophageal reflux disease	6.5% 5/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Skin and subcutaneous tissue disorders Rash	36.4% 28/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Skin and subcutaneous tissue disorders Dermatitis acneiform	19.5% 15/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Skin and subcutaneous tissue disorders Pruritus	14.3% 11/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Skin and subcutaneous tissue disorders Rash maculo-papular	14.3% 11/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Skin and subcutaneous tissue disorders Dry skin	6.5% 5/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
General disorders Fatigue	29.9% 23/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
General disorders Oedema peripheral	20.8% 16/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
General disorders Disease progression	18.2% 14/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
General disorders Pyrexia	13.0% 10/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Metabolism and nutrition disorders Hypoalbuminaemia	26.0% 20/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Metabolism and nutrition disorders Decreased appetite	22.1% 17/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Metabolism and nutrition disorders Hyponatraemia	22.1% 17/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Metabolism and nutrition disorders Dehydration	9.1% 7/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Metabolism and nutrition disorders Hypokalaemia	9.1% 7/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Metabolism and nutrition disorders Hypophosphataemia	7.8% 6/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Metabolism and nutrition disorders Hyperphosphataemia	5.2% 4/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Metabolism and nutrition disorders Hyperuricaemia	5.2% 4/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Metabolism and nutrition disorders Hypocalcaemia	5.2% 4/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Investigations Blood creatinine increased	26.0% 20/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Investigations Aspartate aminotransferase increased	15.6% 12/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Investigations Alanine aminotransferase increased	14.3% 11/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Investigations Blood alkaline phosphatase increased	7.8% 6/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Investigations Blood bilirubin increased	6.5% 5/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Investigations Blood lactate dehydrogenase increased	6.5% 5/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Investigations Lymphocyte count decreased	6.5% 5/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Investigations Platelet count decreased	5.2% 4/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Investigations Weight decreased	5.2% 4/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Blood and lymphatic system disorders Anaemia	28.6% 22/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Blood and lymphatic system disorders Thrombocytopenia	5.2% 4/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.7% 9/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Respiratory, thoracic and mediastinal disorders Cough	6.5% 5/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Infections and infestations Urinary tract infection	15.6% 12/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Infections and infestations Pneumonia	7.8% 6/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Infections and infestations Rash pustular	5.2% 4/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Nervous system disorders Dizziness	15.6% 12/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Nervous system disorders Headache	7.8% 6/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Nervous system disorders Syncope	5.2% 4/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Musculoskeletal and connective tissue disorders Back pain	10.4% 8/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Musculoskeletal and connective tissue disorders Pain in extremity	7.8% 6/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Musculoskeletal and connective tissue disorders Muscular weakness	6.5% 5/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Musculoskeletal and connective tissue disorders Flank pain	5.2% 4/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Renal and urinary disorders Haematuria	5.2% 4/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Renal and urinary disorders Proteinuria	5.2% 4/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Eye disorders Vision blurred	5.2% 4/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Psychiatric disorders Insomnia	7.8% 6/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Vascular disorders Hypotension	10.4% 8/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Vascular disorders Hypertension	5.2% 4/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	6.5% 5/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.
Cardiac disorders Tachycardia	7.8% 6/77 • All reportable events were recorded with start dates occurring any time after informed consent obtained through and including 30 calendar days after the last administration of ulixertinib, an average of 2.72 months per patient. If the patient begins a new anti-cancer therapy, the safety reporting period ends at the time the new treatment is started, however, death must always be reported when it occurs during the 30-day reporting period irrespective of intervening treatment. If there is more than one medical history within a system organ class (SOC), the patient is counted only once under that SOC. If there is more than one medical history within a SOC and preferred term (PT), the patient is counted only once in that SOC and PT. AEs were collected/assessed at each study visit.

Additional Information

Caroline Emery, PhD

Biomed Valley Discoveries

Phone: 816-960-4615

Email: cemery@biomed-valley.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place