Trial Outcomes & Findings for Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥1 to <7 Years With NF1-related Symptomatic, Inoperable PN (NCT NCT05309668)
NCT ID: NCT05309668
Last Updated: 2025-12-18
Results Overview
To determine the pharmacokinetics of selumetinib after administration of the selumetinib granule formulation
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Pre-dose and 1, 2, 3, 4, 6, 8 and 10-12 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1) (each cycle is 28 days)
Results posted on
2025-12-18
Participant Flow
The study is active, not recruiting and conducted in 7 countries with 39 patients who gave informed consent on or prior to 15 January 2024. Results are reported for the study at data cut-off 1 (DCO1) 08 April 2024.
Eligible patients aged \>= 1 to \< 7 years at the time of informed consent with a diagnosis of NF1 with symptomatic inoperable PN fall into one of three cohorts: Global Cohort 1 (\>=4 to \<7 years), Global Cohort 2 (\>=1 to \<4 years), or Japan Cohort (\>=1 to \<7 years).
Participant milestones
| Measure |
Global Cohort 1
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
Global Cohort 2 (\>=1 to \<4 years)
|
Japan Cohort
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
17
|
4
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
17
|
4
|
Reasons for withdrawal
| Measure |
Global Cohort 1
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
Global Cohort 2 (\>=1 to \<4 years)
|
Japan Cohort
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|
|
Overall Study
Ongoing at data cut-off
|
14
|
17
|
4
|
Baseline Characteristics
Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥1 to <7 Years With NF1-related Symptomatic, Inoperable PN
Baseline characteristics by cohort
| Measure |
Global Cohort 1
n=15 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=17 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Japan Cohort
n=4 Participants
Japan Cohort (\>=1 to \<7 years)
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Country
Italy
|
3 Participants
n=47 Participants
|
6 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
9 Participants
n=9 Participants
|
|
Age, Continuous
|
5.08 years
STANDARD_DEVIATION 1.101 • n=47 Participants
|
2.49 years
STANDARD_DEVIATION 0.819 • n=41 Participants
|
4.43 years
STANDARD_DEVIATION 2.300 • n=88 Participants
|
3.78 years
STANDARD_DEVIATION 1.681 • n=9 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=47 Participants
|
7 Participants
n=41 Participants
|
2 Participants
n=88 Participants
|
14 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=47 Participants
|
10 Participants
n=41 Participants
|
2 Participants
n=88 Participants
|
22 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=47 Participants
|
2 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
4 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=47 Participants
|
15 Participants
n=41 Participants
|
4 Participants
n=88 Participants
|
32 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=47 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=47 Participants
|
0 Participants
n=41 Participants
|
4 Participants
n=88 Participants
|
5 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=47 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
1 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=47 Participants
|
13 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
22 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=47 Participants
|
2 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
4 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
3 Participants
n=47 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
4 Participants
n=9 Participants
|
|
Country
Germany
|
5 Participants
n=47 Participants
|
4 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
9 Participants
n=9 Participants
|
|
Country
Japan
|
0 Participants
n=47 Participants
|
0 Participants
n=41 Participants
|
4 Participants
n=88 Participants
|
4 Participants
n=9 Participants
|
|
Country
Russian Federation (the)
|
2 Participants
n=47 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
2 Participants
n=9 Participants
|
|
Country
Spain
|
4 Participants
n=47 Participants
|
4 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
8 Participants
n=9 Participants
|
|
Country
United States of America (the)
|
1 Participants
n=47 Participants
|
3 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
4 Participants
n=9 Participants
|
|
BSA
|
0.771 m2
STANDARD_DEVIATION 0.1073 • n=47 Participants
|
0.558 m2
STANDARD_DEVIATION 0.0603 • n=41 Participants
|
0.605 m2
STANDARD_DEVIATION 0.1234 • n=88 Participants
|
0.652 m2
STANDARD_DEVIATION 0.1349 • n=9 Participants
|
|
Body surface area group (m2)
>=0.40 to <0.50
|
0 Participants
n=47 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=88 Participants
|
2 Participants
n=9 Participants
|
|
Body surface area group (m2)
>=0.50 to <0.60
|
0 Participants
n=47 Participants
|
11 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
11 Participants
n=9 Participants
|
|
Body surface area group (m2)
>=0.60 to <0.70
|
3 Participants
n=47 Participants
|
5 Participants
n=41 Participants
|
3 Participants
n=88 Participants
|
11 Participants
n=9 Participants
|
|
Body surface area group (m2)
>=0.70 to <0.90
|
10 Participants
n=47 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
10 Participants
n=9 Participants
|
|
Body surface area group (m2)
>=0.90 to <1.10
|
2 Participants
n=47 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
2 Participants
n=9 Participants
|
|
Body surface area group (m2)
>=1.10 to <=1.29
|
0 Participants
n=47 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 1, 2, 3, 4, 6, 8 and 10-12 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1) (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Japan Cohort was not considered for the primary endpoint analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To determine the pharmacokinetics of selumetinib after administration of the selumetinib granule formulation
Outcome measures
| Measure |
Global Cohort 1
n=13 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=15 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=28 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib AUC0-12 Derived After Single Dose Administration
|
1902 h*ng/mL
Interval 1647.0 to 2197.0
|
1699 h*ng/mL
Interval 1436.0 to 2009.0
|
1790 h*ng/mL
Interval 1609.0 to 1993.0
|
—
|
PRIMARY outcome
Timeframe: from screening until 30 days after last doseTo assess the safety and tolerability of the selumetinib granule formulation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Twice daily (morning and evening), from the first day of study treatment (Cycle 1 Day 1) for one week, from Cycle 7 Day 1 for one week (each cycle is 28 days)To assess the palatability of the selumetinib granule formulation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 3, 4, 6, 8, 10-12 and 18-24 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1). Pre-dose, 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=15 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=17 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=32 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=4 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib and N-desmethyl Selumetinib AUC0-12 Derived After Single and Multiple Dose Administration
Cycle 2 Day 1: Selumetinib
|
3095 h*ng/mL
Geometric Coefficient of Variation 47.81
|
2114 h*ng/mL
Geometric Coefficient of Variation 49.23
|
2575 h*ng/mL
Geometric Coefficient of Variation 52.23
|
1952 h*ng/mL
Geometric Coefficient of Variation 32.08
|
|
Selumetinib and N-desmethyl Selumetinib AUC0-12 Derived After Single and Multiple Dose Administration
Cycle 2 Day 1: N-desmethyl selumetinib
|
192.9 h*ng/mL
Geometric Coefficient of Variation 33.37
|
135.9 h*ng/mL
Geometric Coefficient of Variation 33.82
|
161.9 h*ng/mL
Geometric Coefficient of Variation 37.97
|
143.3 h*ng/mL
Geometric Coefficient of Variation 14.64
|
|
Selumetinib and N-desmethyl Selumetinib AUC0-12 Derived After Single and Multiple Dose Administration
Cycle 1 Day 1: Selumetinib
|
1902 h*ng/mL
Geometric Coefficient of Variation 24.19
|
1699 h*ng/mL
Geometric Coefficient of Variation 31.02
|
1790 h*ng/mL
Geometric Coefficient of Variation 28.15
|
1526 h*ng/mL
Geometric Coefficient of Variation 25.09
|
|
Selumetinib and N-desmethyl Selumetinib AUC0-12 Derived After Single and Multiple Dose Administration
Cycle 1 Day 1: N-desmethyl selumetinib
|
156.1 h*ng/mL
Geometric Coefficient of Variation 25.76
|
134.0 h*ng/mL
Geometric Coefficient of Variation 34.21
|
144.6 h*ng/mL
Geometric Coefficient of Variation 30.69
|
118.1 h*ng/mL
Geometric Coefficient of Variation 19.56
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 3, 4, 6, 8, 10-12 and 18-24 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1). Pre-dose, 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=15 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=17 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=32 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=4 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib and N-desmethyl Selumetinib Cmax Derived After Single and Multiple Dose Administration
Cycle 1 Day 1: N-desmethyl selumetinib
|
40.53 ng/mL
Geometric Coefficient of Variation 45.76
|
32.73 ng/mL
Geometric Coefficient of Variation 52.62
|
36.14 ng/mL
Geometric Coefficient of Variation 49.99
|
43.11 ng/mL
Geometric Coefficient of Variation 54.06
|
|
Selumetinib and N-desmethyl Selumetinib Cmax Derived After Single and Multiple Dose Administration
Cycle 2 Day 1: Selumetinib
|
843.4 ng/mL
Geometric Coefficient of Variation 42.69
|
502.6 ng/mL
Geometric Coefficient of Variation 58.59
|
656.9 ng/mL
Geometric Coefficient of Variation 58.01
|
644.2 ng/mL
Geometric Coefficient of Variation 23.68
|
|
Selumetinib and N-desmethyl Selumetinib Cmax Derived After Single and Multiple Dose Administration
Cycle 2 Day 1: N-desmethyl selumetinib
|
47.53 ng/mL
Geometric Coefficient of Variation 38.92
|
29.12 ng/mL
Geometric Coefficient of Variation 47.81
|
37.52 ng/mL
Geometric Coefficient of Variation 50.63
|
43.20 ng/mL
Geometric Coefficient of Variation 19.56
|
|
Selumetinib and N-desmethyl Selumetinib Cmax Derived After Single and Multiple Dose Administration
Cycle 1 Day 1: Selumetinib
|
551.1 ng/mL
Geometric Coefficient of Variation 44.21
|
464.7 ng/mL
Geometric Coefficient of Variation 54.05
|
503.0 ng/mL
Geometric Coefficient of Variation 49.58
|
618.4 ng/mL
Geometric Coefficient of Variation 76.36
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 3, 4 and 6 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1). Pre-dose, 1, 2, 3, 4 and 6 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=15 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=17 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=32 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=4 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib and N-desmethyl Selumetinib AUC0-6 Derived After Single and Multiple Dose Administration
Cycle 1 Day 1: Selumetinib
|
1516 h*ng/mL
Geometric Coefficient of Variation 30.42
|
1352 h*ng/mL
Geometric Coefficient of Variation 37.13
|
1426 h*ng/mL
Geometric Coefficient of Variation 34.05
|
1303 h*ng/mL
Geometric Coefficient of Variation 32.65
|
|
Selumetinib and N-desmethyl Selumetinib AUC0-6 Derived After Single and Multiple Dose Administration
Cycle 2 Day 1: Selumetinib
|
2412 h*ng/mL
Geometric Coefficient of Variation 43.55
|
1672 h*ng/mL
Geometric Coefficient of Variation 48.14
|
2021 h*ng/mL
Geometric Coefficient of Variation 49.40
|
1630 h*ng/mL
Geometric Coefficient of Variation 31.40
|
|
Selumetinib and N-desmethyl Selumetinib AUC0-6 Derived After Single and Multiple Dose Administration
Cycle 2 Day 1: N-desmethyl selumetinib
|
145.6 h*ng/mL
Geometric Coefficient of Variation 31.30
|
102.4 h*ng/mL
Geometric Coefficient of Variation 35.17
|
122.8 h*ng/mL
Geometric Coefficient of Variation 37.71
|
113.0 h*ng/mL
Geometric Coefficient of Variation 14.43
|
|
Selumetinib and N-desmethyl Selumetinib AUC0-6 Derived After Single and Multiple Dose Administration
Cycle 1 Day 1: N-desmethyl selumetinib
|
118.3 h*ng/mL
Geometric Coefficient of Variation 31.40
|
99.73 h*ng/mL
Geometric Coefficient of Variation 36.98
|
108.0 h*ng/mL
Geometric Coefficient of Variation 35.04
|
96.22 h*ng/mL
Geometric Coefficient of Variation 28.26
|
SECONDARY outcome
Timeframe: At screening, at week 17 (Cycle5 Day1), week 33 (Cycle9 Day1), week 49 (Cycle13 Day1), week 73 (Cycle19 Day1) and week 97 (Cycle25 Day1), end of treatment (each cycle is 28 days)To evaluate the efficacy of the selumetinib granule formulation by assessment of Objective Response Rate
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 3, 4, 6, 8, 10-12 and 18-24 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1). Pre-dose, 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=15 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=17 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=32 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=4 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib and N-desmethyl Selumetinib AUClast Derived After Single and Multiple Dose Administration
Cycle 1 Day 1: Selumetinib
|
2208 h*ng/mL
Geometric Coefficient of Variation 24.81
|
1932 h*ng/mL
Geometric Coefficient of Variation 29.59
|
2055 h*ng/mL
Geometric Coefficient of Variation 27.85
|
1709 h*ng/mL
Geometric Coefficient of Variation 20.33
|
|
Selumetinib and N-desmethyl Selumetinib AUClast Derived After Single and Multiple Dose Administration
Cycle 1 Day 1: N-desmethyl selumetinib
|
167.7 h*ng/mL
Geometric Coefficient of Variation 32.98
|
129.7 h*ng/mL
Geometric Coefficient of Variation 38.46
|
146.2 h*ng/mL
Geometric Coefficient of Variation 37.93
|
113.1 h*ng/mL
Geometric Coefficient of Variation 21.03
|
|
Selumetinib and N-desmethyl Selumetinib AUClast Derived After Single and Multiple Dose Administration
Cycle 2 Day 1: Selumetinib
|
2919 h*ng/mL
Geometric Coefficient of Variation 48.28
|
2031 h*ng/mL
Geometric Coefficient of Variation 49.45
|
2450 h*ng/mL
Geometric Coefficient of Variation 52.12
|
1887 h*ng/mL
Geometric Coefficient of Variation 32.22
|
|
Selumetinib and N-desmethyl Selumetinib AUClast Derived After Single and Multiple Dose Administration
Cycle 2 Day 1: N-desmethyl selumetinib
|
183.4 h*ng/mL
Geometric Coefficient of Variation 34.54
|
128.9 h*ng/mL
Geometric Coefficient of Variation 34.30
|
154.7 h*ng/mL
Geometric Coefficient of Variation 38.80
|
137.2 h*ng/mL
Geometric Coefficient of Variation 14.86
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 3, 4, 6, 8, 10-12 and 18-24 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1). Pre-dose, 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=15 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=17 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=32 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=4 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib and N-desmethyl Selumetinib Tmax Derived After Single and Multiple Dose Administration
Cycle 1 Day 1: Selumetinib
|
1.83 h
Interval 0.83 to 2.98
|
2.00 h
Interval 1.0 to 3.88
|
1.97 h
Interval 0.83 to 3.88
|
2.47 h
Interval 1.02 to 2.95
|
|
Selumetinib and N-desmethyl Selumetinib Tmax Derived After Single and Multiple Dose Administration
Cycle 1 Day 1: N-desmethyl selumetinib
|
1.83 h
Interval 0.83 to 2.98
|
2.02 h
Interval 1.0 to 5.87
|
2.00 h
Interval 0.83 to 5.87
|
2.47 h
Interval 1.02 to 2.95
|
|
Selumetinib and N-desmethyl Selumetinib Tmax Derived After Single and Multiple Dose Administration
Cycle 2 Day 1: N-desmethyl selumetinib
|
2.00 h
Interval 0.92 to 4.07
|
2.01 h
Interval 0.92 to 4.05
|
2.00 h
Interval 0.92 to 4.07
|
1.56 h
Interval 0.98 to 2.0
|
|
Selumetinib and N-desmethyl Selumetinib Tmax Derived After Single and Multiple Dose Administration
Cycle 2 Day 1: Selumetinib
|
2.00 h
Interval 0.92 to 4.07
|
1.97 h
Interval 0.92 to 4.05
|
2.00 h
Interval 0.92 to 4.07
|
1.05 h
Interval 0.97 to 2.0
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 3, 4, 6, 8, 10-12 and 18-24 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1). Pre-dose, 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=15 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=17 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=32 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=4 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib and N-desmethyl Selumetinib Tlast Derived After Single and Multiple Dose Administration
Cycle 1 Day 1: Selumetinib
|
23.10 h
Interval 21.58 to 24.0
|
23.25 h
Interval 22.17 to 24.0
|
23.20 h
Interval 21.58 to 24.0
|
22.43 h
Interval 21.3 to 22.9
|
|
Selumetinib and N-desmethyl Selumetinib Tlast Derived After Single and Multiple Dose Administration
Cycle 1 Day 1: N-desmethyl selumetinib
|
10.12 h
Interval 10.0 to 24.0
|
10.02 h
Interval 7.65 to 22.67
|
10.03 h
Interval 7.65 to 24.0
|
10.23 h
Interval 7.67 to 10.33
|
|
Selumetinib and N-desmethyl Selumetinib Tlast Derived After Single and Multiple Dose Administration
Cycle 2 Day 1: Selumetinib
|
10.00 h
Interval 8.03 to 12.0
|
10.00 h
Interval 9.58 to 12.0
|
10.00 h
Interval 8.03 to 12.0
|
10.23 h
Interval 10.17 to 10.32
|
|
Selumetinib and N-desmethyl Selumetinib Tlast Derived After Single and Multiple Dose Administration
Cycle 2 Day 1: N-desmethyl selumetinib
|
10.00 h
Interval 8.03 to 12.0
|
10.00 h
Interval 9.58 to 12.0
|
10.00 h
Interval 8.03 to 12.0
|
10.23 h
Interval 10.17 to 10.32
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 3, 4, 6, 8, 10-12 and 18-24 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1) (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=13 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=15 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=28 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=3 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib and N-desmethyl Selumetinib AUC0-24 Derived After Single Dose Administration
Cycle 1 Day 1: Selumetinib
|
2222 h*ng/mL
Geometric Coefficient of Variation 24.72
|
1942 h*ng/mL
Geometric Coefficient of Variation 29.73
|
2067 h*ng/mL
Geometric Coefficient of Variation 27.91
|
1568 h*ng/mL
Geometric Coefficient of Variation 7.648
|
|
Selumetinib and N-desmethyl Selumetinib AUC0-24 Derived After Single Dose Administration
Cycle 1 Day 1: N-desmethyl selumetinib
|
182.4 h*ng/mL
Geometric Coefficient of Variation 27.93
|
148.3 h*ng/mL
Geometric Coefficient of Variation 37.04
|
164.5 h*ng/mL
Geometric Coefficient of Variation 33.92
|
129.8 h*ng/mL
Geometric Coefficient of Variation 13.54
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 3, 4, 6, 8, 10-12 and 18-24 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1) (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=12 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=15 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=27 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=3 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib CL/F Derived After Single Dose Administration
|
8.411 L/h
Geometric Coefficient of Variation 19.66
|
6.167 L/h
Geometric Coefficient of Variation 36.79
|
7.079 L/h
Geometric Coefficient of Variation 33.95
|
8.757 L/h
Geometric Coefficient of Variation 2.452
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 3, 4, 6, 8, 10-12 and 18-24 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1) (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=12 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=15 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=27 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=3 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib Vz/F Derived After Single Dose Administration
|
91.63 L
Geometric Coefficient of Variation 33.64
|
64.33 L
Geometric Coefficient of Variation 44.81
|
75.28 L
Geometric Coefficient of Variation 43.86
|
107.2 L
Geometric Coefficient of Variation 50.91
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 3, 4, 6, 8, 10-12 and 18-24 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1) (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=12 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=15 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=27 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=3 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib t1/2λz Derived After Single Dose Administration
|
7.551 h
Geometric Coefficient of Variation 41.21
|
7.230 h
Geometric Coefficient of Variation 58.00
|
7.371 h
Geometric Coefficient of Variation 49.98
|
8.486 h
Geometric Coefficient of Variation 49.40
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=15 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=17 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=32 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=4 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib and N-desmethyl Selumetinib Rac Cmax Derived After Multiple Dose Administration
Cycle 2 Day 1, Selumetinib
|
1.508 Ratio
Geometric Coefficient of Variation 56.59
|
1.104 Ratio
Geometric Coefficient of Variation 92.61
|
1.304 Ratio
Geometric Coefficient of Variation 74.80
|
1.042 Ratio
Geometric Coefficient of Variation 84.39
|
|
Selumetinib and N-desmethyl Selumetinib Rac Cmax Derived After Multiple Dose Administration
Cycle 2 Day 1, N-desmethyl selumetinib
|
1.142 Ratio
Geometric Coefficient of Variation 61.34
|
0.8837 Ratio
Geometric Coefficient of Variation 76.53
|
1.014 Ratio
Geometric Coefficient of Variation 68.79
|
1.002 Ratio
Geometric Coefficient of Variation 46.75
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=15 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=17 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=32 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=4 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib and N-desmethyl Selumetinib RacAUC0-12 Derived After Multiple Dose Administration
Cycle 2 Day 1: Selumetinib
|
1.641 Ratio
Geometric Coefficient of Variation 54.51
|
1.289 Ratio
Geometric Coefficient of Variation 61.20
|
1.461 Ratio
Geometric Coefficient of Variation 58.23
|
1.279 Ratio
Geometric Coefficient of Variation 53.18
|
|
Selumetinib and N-desmethyl Selumetinib RacAUC0-12 Derived After Multiple Dose Administration
Cycle 2 Day 1: N-desmethyl selumetinib
|
1.221 Ratio
Geometric Coefficient of Variation 35.39
|
1.099 Ratio
Geometric Coefficient of Variation 53.72
|
1.163 Ratio
Geometric Coefficient of Variation 43.69
|
1.213 Ratio
Geometric Coefficient of Variation 23.76
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=15 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=14 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=29 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=4 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib CL/F Derived After Multiple Dose Administration
|
6.166 L/h
Geometric Coefficient of Variation 50.01
|
6.051 L/h
Geometric Coefficient of Variation 48.38
|
6.110 L/h
Geometric Coefficient of Variation 48.25
|
6.943 L/h
Geometric Coefficient of Variation 26.97
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=15 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=13 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=28 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=4 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib Vss/F Derived After Multiple Dose Administration
|
33.71 L
Geometric Coefficient of Variation 44.31
|
30.05 L
Geometric Coefficient of Variation 52.48
|
31.96 L
Geometric Coefficient of Variation 47.63
|
31.14 L
Geometric Coefficient of Variation 44.54
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 3, 4, 6, 8, 10-12 and 18-24 hours after selumetinib single dose on Cycle 1 Day 1. Pre-dose, 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=15 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=17 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=32 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=4 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Parent-to-metabolite Ratio for AUC0-6, AUC0-12 and AUC0-24 After Single and Multiple Dose Administration.
Cycle 1 Day 1: MPAUC0-6
|
0.07803 Ratio
Geometric Coefficient of Variation 18.27
|
0.07379 Ratio
Geometric Coefficient of Variation 15.50
|
0.07573 Ratio
Geometric Coefficient of Variation 16.76
|
0.07386 Ratio
Geometric Coefficient of Variation 12.37
|
|
Parent-to-metabolite Ratio for AUC0-6, AUC0-12 and AUC0-24 After Single and Multiple Dose Administration.
Cycle 1 Day 1: MPAUC0-12
|
0.08204 Ratio
Geometric Coefficient of Variation 17.91
|
0.07722 Ratio
Geometric Coefficient of Variation 17.19
|
0.07960 Ratio
Geometric Coefficient of Variation 17.48
|
0.07742 Ratio
Geometric Coefficient of Variation 14.05
|
|
Parent-to-metabolite Ratio for AUC0-6, AUC0-12 and AUC0-24 After Single and Multiple Dose Administration.
Cycle 1 Day 1: MPAUC0-24
|
0.08209 Ratio
Geometric Coefficient of Variation 19.94
|
0.07516 Ratio
Geometric Coefficient of Variation 18.93
|
0.07855 Ratio
Geometric Coefficient of Variation 19.59
|
0.07942 Ratio
Geometric Coefficient of Variation 7.881
|
|
Parent-to-metabolite Ratio for AUC0-6, AUC0-12 and AUC0-24 After Single and Multiple Dose Administration.
Cycle 2 Day 1: MPAUC0-6
|
0.06036 Ratio
Geometric Coefficient of Variation 29.62
|
0.06123 Ratio
Geometric Coefficient of Variation 26.61
|
0.06078 Ratio
Geometric Coefficient of Variation 27.69
|
0.06934 Ratio
Geometric Coefficient of Variation 20.71
|
|
Parent-to-metabolite Ratio for AUC0-6, AUC0-12 and AUC0-24 After Single and Multiple Dose Administration.
Cycle 2 Day 1: MPAUC0-12
|
0.06413 Ratio
Geometric Coefficient of Variation 29.74
|
0.06429 Ratio
Geometric Coefficient of Variation 26.09
|
0.06421 Ratio
Geometric Coefficient of Variation 27.42
|
0.07339 Ratio
Geometric Coefficient of Variation 19.13
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 3, 4, 6, 8, 10-12, and 18-24 hours post-dose after selumetinib single dose on the first day of treatment (Cycle 1 Day 1). Pre-dose and 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=15 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=17 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=32 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=4 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Parent to Metabolite Ratio for Cmax After Single and Multiple Dose Administration.
Cycle 1 Day 1
|
0.07353 Ratio
Geometric Coefficient of Variation 20.68
|
0.07044 Ratio
Geometric Coefficient of Variation 17.43
|
0.07186 Ratio
Geometric Coefficient of Variation 18.76
|
0.06971 Ratio
Geometric Coefficient of Variation 23.12
|
|
Parent to Metabolite Ratio for Cmax After Single and Multiple Dose Administration.
Cycle 2 Day 1
|
0.05635 Ratio
Geometric Coefficient of Variation 38.03
|
0.05794 Ratio
Geometric Coefficient of Variation 26.08
|
0.05711 Ratio
Geometric Coefficient of Variation 32.14
|
0.06706 Ratio
Geometric Coefficient of Variation 20.59
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose and 1, 2, 3, 4, 6, 8, 10-12, and 18-24 hours post-dose after selumetinib single dose on the first day of treatment (Cycle 1 Day 1). Pre-dose and 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=15 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=17 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=32 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=4 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib and N-desmethyl Selumetinib BSA Normalised AUC0-6 After Single and Multiple Dose Administration
Cycle 1 Day 1: Selumetinib
|
1979 (h*ng/mL)/m2
Geometric Coefficient of Variation 31.12
|
2446 (h*ng/mL)/m2
Geometric Coefficient of Variation 40.20
|
2217 (h*ng/mL)/m2
Geometric Coefficient of Variation 37.31
|
2194 (h*ng/mL)/m2
Geometric Coefficient of Variation 58.68
|
|
Selumetinib and N-desmethyl Selumetinib BSA Normalised AUC0-6 After Single and Multiple Dose Administration
Cycle 2 Day 1: Selumetinib
|
3150 (h*ng/mL)/m2
Geometric Coefficient of Variation 48.62
|
3038 (h*ng/mL)/m2
Geometric Coefficient of Variation 48.27
|
3095 (h*ng/mL)/m2
Geometric Coefficient of Variation 47.53
|
2713 (h*ng/mL)/m2
Geometric Coefficient of Variation 28.07
|
|
Selumetinib and N-desmethyl Selumetinib BSA Normalised AUC0-6 After Single and Multiple Dose Administration
Cycle 2 Day 1: N-desmethyl selumetinib
|
190.1 (h*ng/mL)/m2
Geometric Coefficient of Variation 33.01
|
186.0 (h*ng/mL)/m2
Geometric Coefficient of Variation 34.93
|
188.1 (h*ng/mL)/m2
Geometric Coefficient of Variation 33.32
|
188.1 (h*ng/mL)/m2
Geometric Coefficient of Variation 26.55
|
|
Selumetinib and N-desmethyl Selumetinib BSA Normalised AUC0-6 After Single and Multiple Dose Administration
Cycle 1 Day 1: N-desmethyl selumetinib
|
154.4 (h*ng/mL)/m2
Geometric Coefficient of Variation 31.96
|
180.5 (h*ng/mL)/m2
Geometric Coefficient of Variation 38.38
|
167.9 (h*ng/mL)/m2
Geometric Coefficient of Variation 35.82
|
162.0 (h*ng/mL)/m2
Geometric Coefficient of Variation 51.74
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose and 1, 2, 3, 4, 6, 8, 10-12, and 18-24 hours post-dose after selumetinib single dose on the first day of treatment (Cycle 1 Day 1). Pre-dose and 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=15 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=17 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=32 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=4 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib and N-desmethyl Selumetinib BSA Normalised AUC0-12 After Single and Multiple Dose Administration
Cycle 1 Day 1: Selumetinib
|
2482 (h*ng/mL)/m2
Geometric Coefficient of Variation 24.78
|
3074 (h*ng/mL)/m2
Geometric Coefficient of Variation 33.19
|
2784 (h*ng/mL)/m2
Geometric Coefficient of Variation 31.12
|
2569 (h*ng/mL)/m2
Geometric Coefficient of Variation 49.75
|
|
Selumetinib and N-desmethyl Selumetinib BSA Normalised AUC0-12 After Single and Multiple Dose Administration
Cycle 1 Day 1: N-desmethyl selumetinib
|
203.7 (h*ng/mL)/m2
Geometric Coefficient of Variation 26.15
|
242.6 (h*ng/mL)/m2
Geometric Coefficient of Variation 33.67
|
222.3 (h*ng/mL)/m2
Geometric Coefficient of Variation 30.91
|
198.9 (h*ng/mL)/m2
Geometric Coefficient of Variation 41.19
|
|
Selumetinib and N-desmethyl Selumetinib BSA Normalised AUC0-12 After Single and Multiple Dose Administration
Cycle 2 Day 1: N-desmethyl selumetinib
|
247.5 (h*ng/mL)/m2
Geometric Coefficient of Variation 34.34
|
247.0 (h*ng/mL)/m2
Geometric Coefficient of Variation 33.49
|
247.2 (h*ng/mL)/m2
Geometric Coefficient of Variation 33.25
|
238.4 (h*ng/mL)/m2
Geometric Coefficient of Variation 22.82
|
|
Selumetinib and N-desmethyl Selumetinib BSA Normalised AUC0-12 After Single and Multiple Dose Administration
Cycle 2 Day 1: Selumetinib
|
4041 (h*ng/mL)/m2
Geometric Coefficient of Variation 54.06
|
3841 (h*ng/mL)/m2
Geometric Coefficient of Variation 49.45
|
3943 (h*ng/mL)/m2
Geometric Coefficient of Variation 50.90
|
3249 (h*ng/mL)/m2
Geometric Coefficient of Variation 27.13
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose and 1, 2, 3, 4, 6, 8, 10-12, and 18-24 hours post-dose after selumetinib single dose on the first day of treatment (Cycle 1 Day 1). Pre-dose and 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=15 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=17 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=32 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=4 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib and N-desmethyl Selumetinib BSA Normalised AUClast After Single and Multiple Dose Administration
Cycle 1 Day 1: Selumetinib
|
2882 (h*ng/mL)/m2
Geometric Coefficient of Variation 24.86
|
3496 (h*ng/mL)/m2
Geometric Coefficient of Variation 31.00
|
3196 (h*ng/mL)/m2
Geometric Coefficient of Variation 29.58
|
2878 (h*ng/mL)/m2
Geometric Coefficient of Variation 44.70
|
|
Selumetinib and N-desmethyl Selumetinib BSA Normalised AUClast After Single and Multiple Dose Administration
Cycle 1 Day 1: N-desmethyl selumetinib
|
218.8 (h*ng/mL)/m2
Geometric Coefficient of Variation 32.79
|
234.8 (h*ng/mL)/m2
Geometric Coefficient of Variation 37.15
|
227.2 (h*ng/mL)/m2
Geometric Coefficient of Variation 34.70
|
190.5 (h*ng/mL)/m2
Geometric Coefficient of Variation 42.43
|
|
Selumetinib and N-desmethyl Selumetinib BSA Normalised AUClast After Single and Multiple Dose Administration
Cycle 2 Day 1: N-desmethyl selumetinib
|
239.5 (h*ng/mL)/m2
Geometric Coefficient of Variation 37.31
|
234.2 (h*ng/mL)/m2
Geometric Coefficient of Variation 34.28
|
236.9 (h*ng/mL)/m2
Geometric Coefficient of Variation 35.21
|
228.4 (h*ng/mL)/m2
Geometric Coefficient of Variation 23.68
|
|
Selumetinib and N-desmethyl Selumetinib BSA Normalised AUClast After Single and Multiple Dose Administration
Cycle 2 Day 1: Selumetinib
|
3811 (h*ng/mL)/m2
Geometric Coefficient of Variation 54.07
|
3690 (h*ng/mL)/m2
Geometric Coefficient of Variation 49.80
|
3752 (h*ng/mL)/m2
Geometric Coefficient of Variation 51.02
|
3141 (h*ng/mL)/m2
Geometric Coefficient of Variation 27.58
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose and 1, 2, 3, 4, 6, 8, 10-12, and 18-24 hours post-dose after selumetinib single dose on the first day of treatment (Cycle 1 Day 1). Pre-dose and 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=15 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=17 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=32 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=4 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib and N-desmethyl Selumetinib BSA Normalised Cmax After Single and Multiple Dose Administration
Cycle 1 Day 1: Selumetinib
|
719.2 (ng/mL)/m2
Geometric Coefficient of Variation 47.70
|
840.9 (ng/mL)/m2
Geometric Coefficient of Variation 55.12
|
782.0 (ng/mL)/m2
Geometric Coefficient of Variation 51.47
|
1041 (ng/mL)/m2
Geometric Coefficient of Variation 110.3
|
|
Selumetinib and N-desmethyl Selumetinib BSA Normalised Cmax After Single and Multiple Dose Administration
Cycle 2 Day 1: Selumetinib
|
1101 (ng/mL)/m2
Geometric Coefficient of Variation 46.84
|
913.1 (ng/mL)/m2
Geometric Coefficient of Variation 56.39
|
1006 (ng/mL)/m2
Geometric Coefficient of Variation 51.65
|
1072 (ng/mL)/m2
Geometric Coefficient of Variation 32.38
|
|
Selumetinib and N-desmethyl Selumetinib BSA Normalised Cmax After Single and Multiple Dose Administration
Cycle 1 Day 1: N-desmethyl selumetinib
|
52.89 (ng/mL)/m2
Geometric Coefficient of Variation 48.40
|
59.23 (ng/mL)/m2
Geometric Coefficient of Variation 52.39
|
56.20 (ng/mL)/m2
Geometric Coefficient of Variation 49.93
|
72.59 (ng/mL)/m2
Geometric Coefficient of Variation 81.41
|
|
Selumetinib and N-desmethyl Selumetinib BSA Normalised Cmax After Single and Multiple Dose Administration
Cycle 2 Day 1: N-desmethyl selumetinib
|
62.06 (ng/mL)/m2
Geometric Coefficient of Variation 39.05
|
52.90 (ng/mL)/m2
Geometric Coefficient of Variation 45.74
|
57.46 (ng/mL)/m2
Geometric Coefficient of Variation 42.46
|
71.89 (ng/mL)/m2
Geometric Coefficient of Variation 39.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose and 1, 2, 3, 4, 6, 8, 10-12 and 18-24 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1). Pre-dose, 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=15 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=17 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=32 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=4 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib and N-desmethyl Selumetinib Dose Normalised AUC0-6 After Single and Multiple Dose Administration.
Cycle 1 Day 1: Selumetinib
|
77.91 (h*ng/mL)/mg
Geometric Coefficient of Variation 30.23
|
104.5 (h*ng/mL)/mg
Geometric Coefficient of Variation 40.46
|
91.20 (h*ng/mL)/mg
Geometric Coefficient of Variation 38.73
|
96.12 (h*ng/mL)/mg
Geometric Coefficient of Variation 55.13
|
|
Selumetinib and N-desmethyl Selumetinib Dose Normalised AUC0-6 After Single and Multiple Dose Administration.
Cycle 1 Day 1: N-desmethyl selumetinib
|
6.079 (h*ng/mL)/mg
Geometric Coefficient of Variation 33.55
|
7.714 (h*ng/mL)/mg
Geometric Coefficient of Variation 39.05
|
6.906 (h*ng/mL)/mg
Geometric Coefficient of Variation 38.11
|
7.099 (h*ng/mL)/mg
Geometric Coefficient of Variation 48.31
|
|
Selumetinib and N-desmethyl Selumetinib Dose Normalised AUC0-6 After Single and Multiple Dose Administration.
Cycle 2 Day 1: Selumetinib
|
126.4 (h*ng/mL)/mg
Geometric Coefficient of Variation 44.74
|
130.7 (h*ng/mL)/mg
Geometric Coefficient of Variation 47.35
|
128.5 (h*ng/mL)/mg
Geometric Coefficient of Variation 45.14
|
120.3 (h*ng/mL)/mg
Geometric Coefficient of Variation 27.94
|
|
Selumetinib and N-desmethyl Selumetinib Dose Normalised AUC0-6 After Single and Multiple Dose Administration.
Cycle 2 Day 1: N-desmethyl selumetinib
|
7.630 (h*ng/mL)/mg
Geometric Coefficient of Variation 30.30
|
8.003 (h*ng/mL)/mg
Geometric Coefficient of Variation 33.93
|
7.808 (h*ng/mL)/mg
Geometric Coefficient of Variation 31.58
|
8.340 (h*ng/mL)/mg
Geometric Coefficient of Variation 26.01
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose and 1, 2, 3, 4, 6, 8, 10-12, and 18-24 hours post-dose after selumetinib single dose on the first day of treatment (Cycle 1 Day 1). Pre-dose and 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=15 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=17 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=32 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=4 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib and N-desmethyl Selumetinib Dose Normalised AUC0-12 After Single and Multiple Dose Administration
Cycle 1 Day 1: Selumetinib
|
97.73 (h*ng/mL)/mg
Geometric Coefficient of Variation 23.21
|
131.4 (h*ng/mL)/mg
Geometric Coefficient of Variation 33.44
|
114.5 (h*ng/mL)/mg
Geometric Coefficient of Variation 32.58
|
112.6 (h*ng/mL)/mg
Geometric Coefficient of Variation 46.45
|
|
Selumetinib and N-desmethyl Selumetinib Dose Normalised AUC0-12 After Single and Multiple Dose Administration
Cycle 1 Day 1: N-desmethyl selumetinib
|
8.018 (h*ng/mL)/mg
Geometric Coefficient of Variation 27.48
|
10.31 (h*ng/mL)/mg
Geometric Coefficient of Variation 34.57
|
9.091 (h*ng/mL)/mg
Geometric Coefficient of Variation 33.36
|
8.717 (h*ng/mL)/mg
Geometric Coefficient of Variation 37.98
|
|
Selumetinib and N-desmethyl Selumetinib Dose Normalised AUC0-12 After Single and Multiple Dose Administration
Cycle 2 Day 1: Selumetinib
|
162.2 (h*ng/mL)/mg
Geometric Coefficient of Variation 50.01
|
165.3 (h*ng/mL)/mg
Geometric Coefficient of Variation 48.38
|
163.7 (h*ng/mL)/mg
Geometric Coefficient of Variation 48.25
|
144.0 (h*ng/mL)/mg
Geometric Coefficient of Variation 26.97
|
|
Selumetinib and N-desmethyl Selumetinib Dose Normalised AUC0-12 After Single and Multiple Dose Administration
Cycle 2 Day 1: N-desmethyl selumetinib
|
9.935 (h*ng/mL)/mg
Geometric Coefficient of Variation 30.66
|
10.63 (h*ng/mL)/mg
Geometric Coefficient of Variation 32.24
|
10.27 (h*ng/mL)/mg
Geometric Coefficient of Variation 31.05
|
10.57 (h*ng/mL)/mg
Geometric Coefficient of Variation 22.24
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose and 1, 2, 3, 4, 6, 8, 10-12, and 18-24 hours post-dose after selumetinib single dose on the first day of treatment (Cycle 1 Day 1). Pre-dose and 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=15 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=17 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=32 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=4 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib and N-desmethyl Selumetinib Dose Normalised AUClast After Single and Multiple Dose Administration
Cycle 1 Day 1: N-desmethyl selumetinib
|
8.615 (h*ng/mL)/mg
Geometric Coefficient of Variation 33.17
|
10.03 (h*ng/mL)/mg
Geometric Coefficient of Variation 38.03
|
9.349 (h*ng/mL)/mg
Geometric Coefficient of Variation 36.09
|
8.347 (h*ng/mL)/mg
Geometric Coefficient of Variation 39.21
|
|
Selumetinib and N-desmethyl Selumetinib Dose Normalised AUClast After Single and Multiple Dose Administration
Cycle 2 Day 1: Selumetinib
|
152.9 (h*ng/mL)/mg
Geometric Coefficient of Variation 50.13
|
158.8 (h*ng/mL)/mg
Geometric Coefficient of Variation 48.72
|
155.7 (h*ng/mL)/mg
Geometric Coefficient of Variation 48.51
|
139.2 (h*ng/mL)/mg
Geometric Coefficient of Variation 27.44
|
|
Selumetinib and N-desmethyl Selumetinib Dose Normalised AUClast After Single and Multiple Dose Administration
Cycle 2 Day 1: N-desmethyl selumetinib
|
9.613 (h*ng/mL)/mg
Geometric Coefficient of Variation 34.31
|
10.08 (h*ng/mL)/mg
Geometric Coefficient of Variation 33.00
|
9.834 (h*ng/mL)/mg
Geometric Coefficient of Variation 33.14
|
10.12 (h*ng/mL)/mg
Geometric Coefficient of Variation 23.11
|
|
Selumetinib and N-desmethyl Selumetinib Dose Normalised AUClast After Single and Multiple Dose Administration
Cycle 1 Day 1: Selumetinib
|
113.4 (h*ng/mL)/mg
Geometric Coefficient of Variation 23.10
|
149.4 (h*ng/mL)/mg
Geometric Coefficient of Variation 31.40
|
131.5 (h*ng/mL)/mg
Geometric Coefficient of Variation 30.94
|
126.1 (h*ng/mL)/mg
Geometric Coefficient of Variation 41.51
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose and 1, 2, 3, 4, 6, 8, 10-12, and 18-24 hours post-dose after selumetinib single dose on the first day of treatment (Cycle 1 Day 1). Pre-dose and 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days)Population: Pharmacokinetic analysis set was used for analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
To further evaluate the PK of the granule formulation.
Outcome measures
| Measure |
Global Cohort 1
n=15 Participants
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=17 Participants
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=32 Participants
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=4 Participants
Japan Cohort (\>=1 to \<7 years)
|
|---|---|---|---|---|
|
Selumetinib and N-desmethyl Selumetinib Dose Normalised Cmax After Single and Multiple Dose Administration
Cycle 1 Day 1: N-desmethyl selumetinib
|
2.082 (ng/mL)/mg
Geometric Coefficient of Variation 50.61
|
2.532 (ng/mL)/mg
Geometric Coefficient of Variation 53.47
|
2.312 (ng/mL)/mg
Geometric Coefficient of Variation 52.27
|
3.181 (ng/mL)/mg
Geometric Coefficient of Variation 77.41
|
|
Selumetinib and N-desmethyl Selumetinib Dose Normalised Cmax After Single and Multiple Dose Administration
Cycle 2 Day 1: Selumetinib
|
44.20 (ng/mL)/mg
Geometric Coefficient of Variation 43.64
|
39.29 (ng/mL)/mg
Geometric Coefficient of Variation 55.51
|
41.76 (ng/mL)/mg
Geometric Coefficient of Variation 49.03
|
47.52 (ng/mL)/mg
Geometric Coefficient of Variation 32.01
|
|
Selumetinib and N-desmethyl Selumetinib Dose Normalised Cmax After Single and Multiple Dose Administration
Cycle 2 Day 1: N-desmethyl selumetinib
|
2.491 (ng/mL)/mg
Geometric Coefficient of Variation 38.39
|
2.276 (ng/mL)/mg
Geometric Coefficient of Variation 44.76
|
2.385 (ng/mL)/mg
Geometric Coefficient of Variation 41.03
|
3.187 (ng/mL)/mg
Geometric Coefficient of Variation 38.33
|
|
Selumetinib and N-desmethyl Selumetinib Dose Normalised Cmax After Single and Multiple Dose Administration
Cycle 1 Day 1: Selumetinib
|
28.31 (ng/mL)/mg
Geometric Coefficient of Variation 47.51
|
35.94 (ng/mL)/mg
Geometric Coefficient of Variation 55.90
|
32.17 (ng/mL)/mg
Geometric Coefficient of Variation 52.83
|
45.63 (ng/mL)/mg
Geometric Coefficient of Variation 105.5
|
Adverse Events
Global Cohort 1
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Global Cohort 2
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Total in Global
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
Japan Cohort
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Total in Study
Serious events: 2 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Global Cohort 1
n=15 participants at risk
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=17 participants at risk
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=32 participants at risk
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=4 participants at risk
Japan Cohort (\>=1 to \<7 years)
|
Total in Study
n=36 participants at risk
Total in study (\>=1 to \<7 years)
|
|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
Other adverse events
| Measure |
Global Cohort 1
n=15 participants at risk
Global Cohort 1 (\>=4 to \<7 years)
|
Global Cohort 2
n=17 participants at risk
Global Cohort 2 (\>=1 to \<4 years)
|
Total in Global
n=32 participants at risk
Global Cohorts (\>=1 to \<7 years)
|
Japan Cohort
n=4 participants at risk
Japan Cohort (\>=1 to \<7 years)
|
Total in Study
n=36 participants at risk
Total in study (\>=1 to \<7 years)
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
6.2%
2/32 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.6%
2/36 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Psychiatric disorders
Irritability
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
6.2%
2/32 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.6%
2/36 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Psychiatric disorders
Staring
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
11.8%
2/17 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
9.4%
3/32 • Number of events 6 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
8.3%
3/36 • Number of events 6 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
11.8%
2/17 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
9.4%
3/32 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
8.3%
3/36 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
17.6%
3/17 • Number of events 4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
12.5%
4/32 • Number of events 5 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
11.1%
4/36 • Number of events 5 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.3%
2/15 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
35.3%
6/17 • Number of events 7 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
25.0%
8/32 • Number of events 9 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
22.2%
8/36 • Number of events 9 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
6.7%
1/15 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
11.8%
2/17 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
6.2%
2/32 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.6%
2/36 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
60.0%
9/15 • Number of events 10 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
47.1%
8/17 • Number of events 9 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
53.1%
17/32 • Number of events 19 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
47.2%
17/36 • Number of events 19 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
40.0%
6/15 • Number of events 7 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
29.4%
5/17 • Number of events 7 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
34.4%
11/32 • Number of events 14 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
75.0%
3/4 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
38.9%
14/36 • Number of events 17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
20.0%
3/15 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
9.4%
3/32 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
8.3%
3/36 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
20.0%
3/15 • Number of events 6 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
17.6%
3/17 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
18.8%
6/32 • Number of events 9 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
16.7%
6/36 • Number of events 9 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
17.6%
3/17 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
9.4%
3/32 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
8.3%
3/36 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
6.2%
2/32 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.6%
2/36 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
13.3%
2/15 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
9.4%
3/32 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
8.3%
3/36 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
6.2%
2/32 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.6%
2/36 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
11.8%
2/17 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
9.4%
3/32 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
8.3%
3/36 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Skin and subcutaneous tissue disorders
Trichorrhexis
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Gastrointestinal disorders
Cheilitis
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
9.4%
3/32 • Number of events 4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
8.3%
3/36 • Number of events 4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
6/15 • Number of events 6 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
41.2%
7/17 • Number of events 11 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
40.6%
13/32 • Number of events 17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
25.0%
1/4 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
38.9%
14/36 • Number of events 18 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
6.2%
2/32 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.6%
2/36 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Blood and lymphatic system disorders
Anaemia
|
13.3%
2/15 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
35.3%
6/17 • Number of events 6 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
25.0%
8/32 • Number of events 8 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
22.2%
8/36 • Number of events 8 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Gastrointestinal disorders
Stomatitis
|
13.3%
2/15 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
9.4%
3/32 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
50.0%
2/4 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
13.9%
5/36 • Number of events 5 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Gastrointestinal disorders
Toothache
|
6.7%
1/15 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Gastrointestinal disorders
Vomiting
|
26.7%
4/15 • Number of events 5 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
47.1%
8/17 • Number of events 9 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
37.5%
12/32 • Number of events 14 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
50.0%
2/4 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
38.9%
14/36 • Number of events 16 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
General disorders
Fatigue
|
26.7%
4/15 • Number of events 4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
11.8%
2/17 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
18.8%
6/32 • Number of events 6 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
16.7%
6/36 • Number of events 6 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
General disorders
Localised oedema
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
6.2%
2/32 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.6%
2/36 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
General disorders
Oedema peripheral
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
General disorders
Pyrexia
|
40.0%
6/15 • Number of events 9 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
58.8%
10/17 • Number of events 15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
50.0%
16/32 • Number of events 24 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
44.4%
16/36 • Number of events 24 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
General disorders
Swelling face
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
General disorders
Xerosis
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Anal candidiasis
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Anal fungal infection
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
11.8%
2/17 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
6.2%
2/32 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
25.0%
1/4 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
8.3%
3/36 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Covid-19
|
13.3%
2/15 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
6.2%
2/32 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.6%
2/36 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Conjunctivitis
|
6.7%
1/15 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
6.2%
2/32 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.6%
2/36 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Coronavirus infection
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Cystitis
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
11.8%
2/17 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
6.2%
2/32 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.6%
2/36 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Cystitis bacterial
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Ear infection
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Erythema infectiosum
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Ear and labyrinth disorders
External ear inflammation
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Folliculitis
|
33.3%
5/15 • Number of events 7 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
23.5%
4/17 • Number of events 4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
28.1%
9/32 • Number of events 11 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
25.0%
9/36 • Number of events 11 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Funguria
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Gastroenteritis
|
13.3%
2/15 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
9.4%
3/32 • Number of events 7 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
25.0%
1/4 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
11.1%
4/36 • Number of events 8 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Gastrointestinal infection
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Herpangina
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
11.8%
2/17 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
6.2%
2/32 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.6%
2/36 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Impetigo
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/32 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
25.0%
1/4 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Influenza
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
25.0%
1/4 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.6%
2/36 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Eye disorders
Eye oedema
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Nasopharyngitis
|
26.7%
4/15 • Number of events 6 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
11.8%
2/17 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
18.8%
6/32 • Number of events 8 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
16.7%
6/36 • Number of events 8 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Otitis media
|
13.3%
2/15 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
9.4%
3/32 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
8.3%
3/36 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Paronychia
|
53.3%
8/15 • Number of events 10 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
41.2%
7/17 • Number of events 14 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
46.9%
15/32 • Number of events 24 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
25.0%
1/4 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
44.4%
16/36 • Number of events 25 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Penile infection
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Pharyngitis
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
6.2%
2/32 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.6%
2/36 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Pharyngitis streptococcal
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Pustule
|
6.7%
1/15 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Rash pustular
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Eye disorders
Eyelid skin dryness
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Respiratory tract infection
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Rhinitis
|
13.3%
2/15 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
23.5%
4/17 • Number of events 6 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
18.8%
6/32 • Number of events 8 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
16.7%
6/36 • Number of events 8 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Sinusitis
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Skin infection
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Streptococcal infection
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Tonsillitis
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Upper respiratory tract infection
|
26.7%
4/15 • Number of events 5 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
41.2%
7/17 • Number of events 9 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
34.4%
11/32 • Number of events 14 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
75.0%
3/4 • Number of events 4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
38.9%
14/36 • Number of events 18 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
17.6%
3/17 • Number of events 4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
9.4%
3/32 • Number of events 4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
8.3%
3/36 • Number of events 4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Infections and infestations
Viral infection
|
13.3%
2/15 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
6.2%
2/32 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.6%
2/36 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
13.3%
2/15 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
6.2%
2/32 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.6%
2/36 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Eye disorders
Photophobia
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Injury, poisoning and procedural complications
Face injury
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
6.2%
2/32 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.6%
2/36 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Investigations
Amylase increased
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
6.2%
2/32 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.6%
2/36 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Investigations
Aspartate aminotransferase increased
|
13.3%
2/15 • Number of events 3 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
11.8%
2/17 • Number of events 4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
12.5%
4/32 • Number of events 7 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
11.1%
4/36 • Number of events 7 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Investigations
Blood creatine phosphokinase increased
|
33.3%
5/15 • Number of events 8 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
29.4%
5/17 • Number of events 6 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
31.2%
10/32 • Number of events 14 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
25.0%
1/4 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
30.6%
11/36 • Number of events 16 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Investigations
Body temperature increased
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Eye disorders
Vision blurred
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/32 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
25.0%
1/4 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Investigations
Platelet count decreased
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/32 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
25.0%
1/4 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Metabolism and nutrition disorders
Hyperphosphatasaemia
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
11.8%
2/17 • Number of events 5 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
6.2%
2/32 • Number of events 5 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.6%
2/36 • Number of events 5 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
3/15 • Number of events 4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
11.8%
2/17 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
15.6%
5/32 • Number of events 6 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
13.9%
5/36 • Number of events 6 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
6.2%
2/32 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.6%
2/36 • Number of events 2 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Metabolism and nutrition disorders
Zinc deficiency
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue swelling
|
6.7%
1/15 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Nervous system disorders
Clumsiness
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Number of events 6 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/17 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
6.2%
2/32 • Number of events 6 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.6%
2/36 • Number of events 6 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/15 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
5.9%
1/17 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
3.1%
1/32 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
0.00%
0/4 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
2.8%
1/36 • Number of events 1 • All-cause mortality (death due to any cause): from first dose of study medication up to and including the data cut-off 1 analysis (08Apr2024), up to 26 months. Treatment-emergent adverse events: from first dose of study medication up to and including 30 days after the last dose of selumetinib, an average of 12.6 months.
All-cause mortality was reported for all subjects. Adverse events were reported for subjects who received at least one dose of study drug, and includes AEs that start prior to and worsen after treatment or with an onset or worsening date on or after the date of first selumetinib dose up to and including 30 days after the date of last selumetinib dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place