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.
TERMINATED
PHASE2
47 participants
from cycle 1 day 1 until safety follow-up visit (up to 24 months)
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
| 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
| 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
| 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
| 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
| 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
| 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 monthsPopulation: 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
| 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
Stage 1 - Pancreas
Stage 1 - Colorectal
Stage 1 - Esophageal
Stage 1 - Gastric
Stage 2 - Basket Expansion Based on Stage 1
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
| 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place