Trial Outcomes & Findings for Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies (NCT NCT05221320)

NCT ID: NCT05221320

Last Updated: 2025-09-25

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

47 participants

Primary outcome timeframe

from cycle 1 day 1 until safety follow-up visit (up to 24 months)

Results posted on

2025-09-25

Participant Flow

The study was conducted at 9 sites in the USA. Enrollment took place between May 2022 and July 2024.

Participant milestones

Participant milestones
Measure
Basket 1: Cholangiocarcinoma Including Intrahepatic, Perihilar, Extrahepatic Cholangiocarcinoma
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 2 - Pancreatic Adenocarcinoma
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 3 - Colorectal Adenocarcinoma
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 4 - Esophageal Adenocarcinoma, Esophageal Squamous Cell Gastroesophageal Junction Adeno
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 5 - Gastric Adenocarcinoma
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Stage 2 - Basket Expansion Based on Stage 1
Ulixertinib: 450mg BID, orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Overall Study
STARTED
4
18
22
2
1
0
Overall Study
COMPLETED
0
3
2
0
0
0
Overall Study
NOT COMPLETED
4
15
20
2
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Basket 1: Cholangiocarcinoma Including Intrahepatic, Perihilar, Extrahepatic Cholangiocarcinoma
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 2 - Pancreatic Adenocarcinoma
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 3 - Colorectal Adenocarcinoma
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 4 - Esophageal Adenocarcinoma, Esophageal Squamous Cell Gastroesophageal Junction Adeno
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 5 - Gastric Adenocarcinoma
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Stage 2 - Basket Expansion Based on Stage 1
Ulixertinib: 450mg BID, orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Overall Study
Lack of Efficacy
3
7
10
1
0
0
Overall Study
Physician Decision
1
0
3
1
0
0
Overall Study
Withdrawal by Subject
0
3
1
0
0
0
Overall Study
Death
0
5
6
0
1
0

Baseline Characteristics

Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Basket 1: Cholangiocarcinoma Including Intrahepatic, Perihilar, Extrahepatic Cholangiocarcinoma
n=4 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 2: Pancreatic Adenocarcinoma
n=18 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 3: Colorectal Adenocarcinoma
n=22 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 4: Esophageal Adenocarcinoma, Esophageal Squamous Cell, Gastroesophageal Junction
n=2 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 5: Gastric Adenocarcinoma
n=1 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Stage 2 - Basket Expansion Based on Stage 1
Ulixertinib: 450mg BID, orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Total
n=47 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
0 Participants
n=3 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=99 Participants
10 Participants
n=107 Participants
17 Participants
n=206 Participants
2 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
30 Participants
n=3 Participants
Age, Categorical
>=65 years
3 Participants
n=99 Participants
8 Participants
n=107 Participants
5 Participants
n=206 Participants
0 Participants
n=7 Participants
1 Participants
n=31 Participants
0 Participants
n=30 Participants
17 Participants
n=3 Participants
Age, Continuous
62.0 Years
STANDARD_DEVIATION 14.17 • n=99 Participants
62.2 Years
STANDARD_DEVIATION 8.53 • n=107 Participants
57.0 Years
STANDARD_DEVIATION 10.76 • n=206 Participants
58.5 Years
STANDARD_DEVIATION 6.36 • n=7 Participants
68.0 Years
n=31 Participants
59.7 Years
STANDARD_DEVIATION 10.08 • n=3 Participants
Sex: Female, Male
Female
2 Participants
n=99 Participants
9 Participants
n=107 Participants
7 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
18 Participants
n=3 Participants
Sex: Female, Male
Male
2 Participants
n=99 Participants
9 Participants
n=107 Participants
15 Participants
n=206 Participants
2 Participants
n=7 Participants
1 Participants
n=31 Participants
0 Participants
n=30 Participants
29 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
0 Participants
n=107 Participants
3 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
3 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants
n=99 Participants
17 Participants
n=107 Participants
19 Participants
n=206 Participants
2 Participants
n=7 Participants
1 Participants
n=31 Participants
0 Participants
n=30 Participants
43 Participants
n=3 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
1 Participants
n=3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
1 Participants
n=3 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
2 Participants
n=107 Participants
1 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
3 Participants
n=3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
0 Participants
n=3 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
4 Participants
n=3 Participants
Race (NIH/OMB)
White
3 Participants
n=99 Participants
14 Participants
n=107 Participants
19 Participants
n=206 Participants
2 Participants
n=7 Participants
1 Participants
n=31 Participants
0 Participants
n=30 Participants
39 Participants
n=3 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
0 Participants
n=3 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
0 Participants
n=3 Participants
Region of Enrollment
United States
4 Participants
n=99 Participants
18 Participants
n=107 Participants
22 Participants
n=206 Participants
2 Participants
n=7 Participants
1 Participants
n=31 Participants
0 Participants
n=30 Participants
47 Participants
n=3 Participants
ECOG Performance at Baseline
ECOG 0
1 Participants
n=99 Participants
5 Participants
n=107 Participants
11 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
17 Participants
n=3 Participants
ECOG Performance at Baseline
ECOG 1
3 Participants
n=99 Participants
13 Participants
n=107 Participants
10 Participants
n=206 Participants
2 Participants
n=7 Participants
1 Participants
n=31 Participants
0 Participants
n=30 Participants
29 Participants
n=3 Participants
ECOG Performance at Baseline
ECOG 2
0 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
1 Participants
n=3 Participants
Smoking History
Yes - Current Smoker
0 Participants
n=99 Participants
3 Participants
n=107 Participants
1 Participants
n=206 Participants
1 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
5 Participants
n=3 Participants
Smoking History
Yes - Former
1 Participants
n=99 Participants
5 Participants
n=107 Participants
9 Participants
n=206 Participants
1 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
16 Participants
n=3 Participants
Smoking History
No - never smoked
3 Participants
n=99 Participants
10 Participants
n=107 Participants
12 Participants
n=206 Participants
0 Participants
n=7 Participants
1 Participants
n=31 Participants
0 Participants
n=30 Participants
26 Participants
n=3 Participants

PRIMARY outcome

Timeframe: from cycle 1 day 1 until safety follow-up visit (up to 24 months)

Population: Outcomes for stage 1 are presented for the total of 47 participants and not broken down by individual basket. None of the patients in Stage 1 met the CR or PR criteria. Stage 2 was never started due to termination of study in Stage 1.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.

Outcome measures

Outcome measures
Measure
Basket 1: Cholangiocarcinoma Including Intrahepatic, Perihilar, Extrahepatic Cholangiocarcinoma
n=4 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 2 - Pancreatic Adenocarcinoma
n=18 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 3 - Colorectal Adenocarcinoma
n=22 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 4 - Esophageal Adenocarcinoma, Esophageal Squamous, Gastroesophageal Junction
n=2 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 5 - Gastric Adenocarcinoma
n=1 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Stage 2 - Basket Expansion Based on Stage 1
Ulixertinib: 450mg BID, orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Overall Response Rate as Defined by the Proportion of Patients Achieving a Confirmed Partial Response (PR) and Complete Response (CR) (Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as Evaluated by the Local Treating Investigator.
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Baseline until safety follow-up visit (up to 24 months)

Population: Stage 2 is zero because study was terminated in stage 1.

Reporting of any SAEs, all SAEs were collected/assessed at each study visit.

Outcome measures

Outcome measures
Measure
Basket 1: Cholangiocarcinoma Including Intrahepatic, Perihilar, Extrahepatic Cholangiocarcinoma
n=4 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 2 - Pancreatic Adenocarcinoma
n=18 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 3 - Colorectal Adenocarcinoma
n=22 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 4 - Esophageal Adenocarcinoma, Esophageal Squamous, Gastroesophageal Junction
n=2 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 5 - Gastric Adenocarcinoma
n=1 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Stage 2 - Basket Expansion Based on Stage 1
Ulixertinib: 450mg BID, orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
The Incidence and Frequency of Serious Adverse Events (SAEs) Characterized by Type, Severity (as Defined by the NCI CTCAE, Version 5.0), Seriousness, Duration, and Relationship to Study Treatment.
3 Participants
10 Participants
12 Participants
0 Participants
1 Participants

PRIMARY outcome

Timeframe: Baseline until safety follow-up visit (up to 24 months)

Population: Stage 2 was never started.

Reporting of any AEs, all AEs were collected/assessed at each study visit.

Outcome measures

Outcome measures
Measure
Basket 1: Cholangiocarcinoma Including Intrahepatic, Perihilar, Extrahepatic Cholangiocarcinoma
n=4 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 2 - Pancreatic Adenocarcinoma
n=18 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 3 - Colorectal Adenocarcinoma
n=22 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 4 - Esophageal Adenocarcinoma, Esophageal Squamous, Gastroesophageal Junction
n=2 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 5 - Gastric Adenocarcinoma
n=1 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Stage 2 - Basket Expansion Based on Stage 1
Ulixertinib: 450mg BID, orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
The Incidence and Frequency of Adverse Events (AEs), Characterized by Type, Severity (as Defined by the NCI CTCAE, Version 5.0), Seriousness, Duration, and Relationship to Study Treatment.
4 Participants
18 Participants
22 Participants
2 Participants
1 Participants

SECONDARY outcome

Timeframe: 18 months

Population: Stage 2 is zero because study was terminated in stage 1.

To assess the duration of efficacy of ulixertinib and hydroxychloroquine in patients with advanced, RAS, non-V600 BRAF, ERK, or MEK mutated gastrointestinal malignancies.

Outcome measures

Outcome measures
Measure
Basket 1: Cholangiocarcinoma Including Intrahepatic, Perihilar, Extrahepatic Cholangiocarcinoma
n=2 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 2 - Pancreatic Adenocarcinoma
n=16 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 3 - Colorectal Adenocarcinoma
n=22 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 4 - Esophageal Adenocarcinoma, Esophageal Squamous, Gastroesophageal Junction
n=2 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Basket 5 - Gastric Adenocarcinoma
n=1 Participants
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Stage 2 - Basket Expansion Based on Stage 1
Ulixertinib: 450mg BID, orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Progression-free Survival (PFS) as Defined as the Time From Study Drug Initiation to the Time of Documented Disease Progression (as Assessed by RECIST 1.1) or Death From Any Cause.
5.5 months
Interval 0.7 to 5.5
1.9 months
Interval 1.7 to 2.1
1.8 months
Interval 1.4 to 1.8
2.8 months
Interval 1.7 to 3.9
0.7 months
Interval 0.7 to 0.7

Adverse Events

Stage 1 - Cholangiocarcinoma

Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths

Stage 1 - Pancreas

Serious events: 10 serious events
Other events: 18 other events
Deaths: 12 deaths

Stage 1 - Colorectal

Serious events: 12 serious events
Other events: 22 other events
Deaths: 15 deaths

Stage 1 - Esophageal

Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths

Stage 1 - Gastric

Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths

Stage 2 - Basket Expansion Based on Stage 1

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Stage 1 - Cholangiocarcinoma
n=4 participants at risk
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Stage 1 - Pancreas
n=18 participants at risk
Basket 2: Pancreatic adenocarcinoma Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Stage 1 - Colorectal
n=22 participants at risk
Basket 3: Colorectal adenocarcinoma Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Stage 1 - Esophageal
n=2 participants at risk
Basket 4: Esophageal adenocarcinoma, esophageal squamous cell carcinoma, or gastroesophageal junction adenocarcinoma Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Stage 1 - Gastric
n=1 participants at risk
Basket 5: Gastric adenocarcinoma Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Stage 2 - Basket Expansion Based on Stage 1
Ulixertinib: 450mg BID, orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Blood and lymphatic system disorders
Anaemia
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/22 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Obstruction gastric
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
11.1%
2/18 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/22 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/18 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Lower gastrointestinal haemorrhage
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/18 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Oesophageal varices haemorrhage
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/18 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/22 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
38.9%
7/18 • Number of events 7 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
22.7%
5/22 • Number of events 5 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/18 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Biliary obstruction
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Cholangitis
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/22 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/22 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
100.0%
1/1 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Bacteraemia
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/18 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
100.0%
1/1 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Spontaneous bacterial peritonitis
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Peritonitis bacterial
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/18 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Electrocardiogram QT prolonged
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
11.1%
2/18 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
9.1%
2/22 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Failure to thrive
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/18 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/22 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/18 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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)
Malignant neoplasm progression
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/18 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/22 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Metabolic encephalopathy
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/18 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Paraesthesia
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/18 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
Product Issues
Device occlusion
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Pleural effusion
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/18 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/22 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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

Other adverse events
Measure
Stage 1 - Cholangiocarcinoma
n=4 participants at risk
Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Stage 1 - Pancreas
n=18 participants at risk
Basket 2: Pancreatic adenocarcinoma Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Stage 1 - Colorectal
n=22 participants at risk
Basket 3: Colorectal adenocarcinoma Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Stage 1 - Esophageal
n=2 participants at risk
Basket 4: Esophageal adenocarcinoma, esophageal squamous cell carcinoma, or gastroesophageal junction adenocarcinoma Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Stage 1 - Gastric
n=1 participants at risk
Basket 5: Gastric adenocarcinoma Ulixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Stage 2 - Basket Expansion Based on Stage 1
Ulixertinib: 450mg BID, orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity
Blood and lymphatic system disorders
Anaemia
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
16.7%
3/18 • Number of events 3 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
18.2%
4/22 • Number of events 4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
9.1%
2/22 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Diarrhoea
50.0%
2/4 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
38.9%
7/18 • Number of events 7 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
63.6%
14/22 • Number of events 14 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
100.0%
2/2 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
100.0%
4/4 • Number of events 4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
44.4%
8/18 • Number of events 8 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
45.5%
10/22 • Number of events 10 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
50.0%
2/4 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
38.9%
7/18 • Number of events 7 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
22.7%
5/22 • Number of events 5 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
22.2%
4/18 • Number of events 4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
36.4%
8/22 • Number of events 8 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
11.1%
2/18 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
31.8%
7/22 • Number of events 7 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Dyspepsis
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
16.7%
3/18 • Number of events 3 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
18.2%
4/22 • Number of events 4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
11.1%
2/18 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
13.6%
3/22 • Number of events 3 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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 distension
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
11.1%
2/18 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
9.1%
2/22 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
38.9%
7/18 • Number of events 7 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
54.5%
12/22 • Number of events 12 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
100.0%
1/1 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
38.9%
7/18 • Number of events 7 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
22.7%
5/22 • Number of events 5 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
22.7%
5/22 • Number of events 5 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
100.0%
1/1 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
13.6%
3/22 • Number of events 3 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Biliary obstruction
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
100.0%
1/1 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Bacteraemia
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
11.1%
2/18 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
100.0%
1/1 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
11.1%
2/18 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
40.9%
9/22 • Number of events 9 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
50.0%
2/4 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
11.1%
2/18 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
31.8%
7/22 • Number of events 7 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
100.0%
4/4 • Number of events 4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
11.1%
2/18 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
18.2%
4/22 • Number of events 4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
22.7%
5/22 • Number of events 5 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
50.0%
2/4 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
18.2%
4/22 • Number of events 4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/18 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
22.7%
5/22 • Number of events 5 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Electrocardiogram QT prolonged
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
11.1%
2/18 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
13.6%
3/22 • Number of events 3 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
50.0%
2/4 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/18 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
13.6%
3/22 • Number of events 3 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/18 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
13.6%
3/22 • Number of events 3 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Protein total decreased
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/18 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
9.1%
2/22 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
50.0%
2/4 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
50.0%
9/18 • Number of events 9 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
36.4%
8/22 • Number of events 8 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
50.0%
1/2 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
50.0%
2/4 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
13.6%
3/22 • Number of events 3 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
100.0%
1/1 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
11.1%
2/18 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
13.6%
3/22 • Number of events 3 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
50.0%
1/2 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/18 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
22.7%
5/22 • Number of events 5 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
11.1%
2/18 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
13.6%
3/22 • Number of events 3 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Hypocalcaemia
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/18 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
13.6%
3/22 • Number of events 3 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Hypophosphataemia
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/18 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
13.6%
3/22 • Number of events 3 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
16.7%
3/18 • Number of events 3 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
13.6%
3/22 • Number of events 3 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Arthralgia
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
11.1%
2/18 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
22.2%
4/18 • Number of events 4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
100.0%
1/1 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Dysgeusia
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
22.2%
4/18 • Number of events 4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/22 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
9.1%
2/22 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
50.0%
1/2 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
11.1%
2/18 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
9.1%
2/22 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Depression
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
11.1%
2/18 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
11.1%
2/18 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
13.6%
3/22 • Number of events 3 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
11.1%
2/18 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
9.1%
2/22 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
100.0%
1/1 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
0.00%
0/4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
13.6%
3/22 • Number of events 3 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
Pleural effusion
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
27.8%
5/18 • Number of events 5 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
27.3%
6/22 • Number of events 6 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
22.2%
4/18 • Number of events 4 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
9.1%
2/22 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
50.0%
1/2 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
9.1%
2/22 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
11.1%
2/18 • Number of events 2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/22 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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
25.0%
1/4 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
5.6%
1/18 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
4.5%
1/22 • Number of events 1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/2 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0.00%
0/1 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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.
0/0 • 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 and hydroxychloroquine. The median (min; max) number of cycles received was 2 (1; 6). The median (min; max) duration of exposure was 1.74 (0.0; 5.5) months. All patients fell well within the estimated 24 months.
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

Deborah Knoerzer, Director Translational Sciences

Biomed Valley Discoveries

Phone: 6368876429

Results disclosure agreements

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