Trial Outcomes & Findings for Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01) (NCT NCT04703192)
NCT ID: NCT04703192
Last Updated: 2025-12-09
Results Overview
For the relapsed/refractory peripheral T-cell lymphoma (PTCL) cohort, objective response rate (ORR) is defined as the proportion of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), assessed by blinded independent central review (BICR), among participants with centrally confirmed PTCL eligible histology.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
155 participants
Primary outcome timeframe
From baseline until disease progression or death (whichever occurs first), up to approximately 23 months
Results posted on
2025-12-09
Participant Flow
A total of 155 participants who met all inclusion criteria and no exclusion criteria were enrolled to receive valemetostat tosylate treatment in 70 study sites in North America, Europe, Asia, and Oceania.
Participant milestones
| Measure |
Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)
Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible peripheral T-cell lymphoma .
|
Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma (ATCL)
Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible adult T-cell leukemia/lymphoma.
|
|---|---|---|
|
Overall Study
STARTED
|
133
|
22
|
|
Overall Study
COMPLETED
|
32
|
2
|
|
Overall Study
NOT COMPLETED
|
101
|
20
|
Reasons for withdrawal
| Measure |
Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)
Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible peripheral T-cell lymphoma .
|
Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma (ATCL)
Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible adult T-cell leukemia/lymphoma.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Death
|
3
|
1
|
|
Overall Study
Adverse Event
|
13
|
2
|
|
Overall Study
Progressive or Relapsed Disease
|
46
|
7
|
|
Overall Study
Clinical Progression
|
19
|
8
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Hematopoietic Cell Transplantation
|
12
|
1
|
|
Overall Study
Other
|
5
|
1
|
Baseline Characteristics
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Baseline characteristics by cohort
| Measure |
Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)
n=133 Participants
Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible peripheral T-cell lymphoma .
|
Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma
n=22 Participants
Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible adult T-cell leukemia/lymphoma.
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=9 Participants
|
10 Participants
n=6 Participants
|
63 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
80 Participants
n=9 Participants
|
12 Participants
n=6 Participants
|
92 Participants
n=9 Participants
|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 12.51 • n=9 Participants
|
62.6 years
STANDARD_DEVIATION 13.11 • n=6 Participants
|
65.2 years
STANDARD_DEVIATION 12.60 • n=9 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
49 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=9 Participants
|
15 Participants
n=6 Participants
|
106 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
34 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
42 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=9 Participants
|
10 Participants
n=6 Participants
|
16 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
81 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
15 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: From baseline until disease progression or death (whichever occurs first), up to approximately 23 monthsPopulation: Efficacy Analysis Set for Cohort 1 is defined as all subjects who received at least 1 dose of valemetostat tosylate and had an eligible PTCL subtype that was confirmed by central hematopathology review.
For the relapsed/refractory peripheral T-cell lymphoma (PTCL) cohort, objective response rate (ORR) is defined as the proportion of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), assessed by blinded independent central review (BICR), among participants with centrally confirmed PTCL eligible histology.
Outcome measures
| Measure |
Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)
n=119 Participants
Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible peripheral T-cell lymphoma .
|
|---|---|
|
Percentage of Participants With Objective Response As Assessed by Blinded Independent Central Review After Administration of Valemetostat Tosylate Monotherapy (Cohort 1)
|
43.7 percentage of participants
Interval 34.6 to 53.1
|
PRIMARY outcome
Timeframe: From the time the informed consent form is signed up to 30 days after last dose, up to 23 monthsTreatment-emergent adverse events (TEAEs) were defined as new AEs or pre-existing conditions that worsen in National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade after the first dose of study drug and up to 30 days after the last dose of study drug.
Outcome measures
| Measure |
Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)
n=22 Participants
Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible peripheral T-cell lymphoma .
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events After Administration of Valemetostat Tosylate Monotherapy (Cohort 2)
|
22 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1, 8, 15 Predose; Cycle 1 Day 1 (1, 2, 4, 5 hours Postdose); Cycle 2 Day 1 Predose; Cycle 3 Day 1 to Cycle 5 Day 1 Predose (each cycle is 28 days)Total and unbound DS-3201a (free form of valemetostat tosylate) and total CALZ-1809a (major metabolite) concentration in plasma will be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from the date of first documented response (CR or PR) until documented disease progression (progressive or relapsed disease) based on BICR assessments or death from any cause (whichever occurs first), up to approximately 56 monthsDuration of response (DoR) is defined as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of disease progression (progressive or relapsed disease) based on BICR assessments or to death due to any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to date of first documented objective response of CR, up to approximately 56 monthsComplete response rate is the percentage of participants achieving CR as the BOR based on BICR assessments.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from the date of first documented CR until documented disease progression (progressive or relapsed disease) based on BICR assessments or death from any cause (whichever occurs first), up to approximately 56 monthsDuration of complete response is defined as the time from the date of the first documentation of CR to the date of the first documentation of disease progression (progressive or relapsed disease) based on BICR assessments or to death due to any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to date of first documented objective response of PR, up to approximately 56 monthsPartial response rate is the percentage of participants achieving PR as the BOR based on BICR assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the time the informed consent form is signed up to 30 days after last doseOutcome measures
Outcome data not reported
Adverse Events
Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)
Serious events: 53 serious events
Other events: 120 other events
Deaths: 52 deaths
Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma
Serious events: 15 serious events
Other events: 22 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)
n=133 participants at risk
Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible peripheral T-cell lymphoma .
|
Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma
n=22 participants at risk
Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible adult T-cell leukemia/lymphoma.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
2/133 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Coombs negative haemolytic anaemia
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Eye disorders
Diplopia
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
2/133 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
9.1%
2/22 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.75%
1/133 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.75%
1/133 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
General disorders
Disease progression
|
5.3%
7/133 • Number of events 7 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
13.6%
3/22 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
General disorders
General physical health deterioration
|
2.3%
3/133 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
General disorders
Asthenia
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
General disorders
Fatigue
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
General disorders
Gait disturbance
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
General disorders
Influenza like illness
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
General disorders
Pyrexia
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.75%
1/133 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
1.5%
2/133 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
COVID-19 pneumonia
|
2.3%
3/133 • Number of events 4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
COVID-19
|
1.5%
2/133 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
9.1%
2/22 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
1.5%
2/133 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
2/133 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
Citrobacter bacteraemia
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
Device related infection
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
Influenza
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
Necrotising fasciitis
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
Pneumonia fungal
|
0.75%
1/133 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
Bacterial abdominal infection
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
Pneumonia adenoviral
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Adult failure to thrive
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperlactacidaemia
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
1.5%
2/133 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm papilla of Vater
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Nervous system disorders
IIIrd nerve disorder
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Nervous system disorders
Motor dysfunction
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
2/133 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Cellulite
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Vascular disorders
Shock haemorrhagic
|
0.75%
1/133 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
Other adverse events
| Measure |
Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)
n=133 participants at risk
Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible peripheral T-cell lymphoma .
|
Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma
n=22 participants at risk
Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible adult T-cell leukemia/lymphoma.
|
|---|---|---|
|
General disorders
Fatigue
|
14.3%
19/133 • Number of events 28 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
9.1%
2/22 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
35.3%
47/133 • Number of events 139 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
50.0%
11/22 • Number of events 41 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
26.3%
35/133 • Number of events 104 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
18.2%
4/22 • Number of events 13 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.5%
18/133 • Number of events 60 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
38/133 • Number of events 56 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
22.7%
5/22 • Number of events 5 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
17.3%
23/133 • Number of events 28 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
18.2%
4/22 • Number of events 5 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
9.8%
13/133 • Number of events 13 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
9.0%
12/133 • Number of events 13 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
13.6%
3/22 • Number of events 4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
General disorders
Pyrexia
|
14.3%
19/133 • Number of events 27 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
13.6%
3/22 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
General disorders
Asthenia
|
12.8%
17/133 • Number of events 22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
9.1%
2/22 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
General disorders
Oedema peripheral
|
12.0%
16/133 • Number of events 18 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
9.1%
2/22 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
COVID-19
|
20.3%
27/133 • Number of events 33 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
18.2%
4/22 • Number of events 4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
7.5%
10/133 • Number of events 16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
9.1%
2/22 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Investigations
Platelet count decreased
|
23.3%
31/133 • Number of events 117 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
40.9%
9/22 • Number of events 40 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
13.5%
18/133 • Number of events 54 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
27.3%
6/22 • Number of events 18 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
10.5%
14/133 • Number of events 26 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
13.6%
3/22 • Number of events 5 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
7.5%
10/133 • Number of events 20 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
13.6%
3/22 • Number of events 7 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Investigations
Weight decreased
|
7.5%
10/133 • Number of events 10 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
6.8%
9/133 • Number of events 17 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Investigations
Electrocardiogram QT prolonged
|
6.0%
8/133 • Number of events 9 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.3%
7/133 • Number of events 19 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
9.1%
2/22 • Number of events 4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Investigations
White blood cell count decreased
|
5.3%
7/133 • Number of events 25 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
18.2%
4/22 • Number of events 8 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Investigations
Blood creatinine increased
|
3.0%
4/133 • Number of events 6 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
9.1%
2/22 • Number of events 6 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
0.75%
1/133 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
9.1%
2/22 • Number of events 7 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
19/133 • Number of events 24 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
13.6%
3/22 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.5%
10/133 • Number of events 12 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
13.6%
3/22 • Number of events 13 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.5%
10/133 • Number of events 18 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
13.6%
3/22 • Number of events 10 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.8%
5/133 • Number of events 10 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
9.1%
2/22 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.0%
4/133 • Number of events 9 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
13.6%
3/22 • Number of events 11 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.0%
4/133 • Number of events 7 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
13.6%
3/22 • Number of events 4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.5%
2/133 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
27.3%
6/22 • Number of events 8 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
9.1%
2/22 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
9.1%
2/22 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
11/133 • Number of events 12 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.0%
8/133 • Number of events 8 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.3%
3/133 • Number of events 3 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
9.1%
2/22 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
28.6%
38/133 • Number of events 44 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
22.7%
5/22 • Number of events 6 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Nervous system disorders
Headache
|
5.3%
7/133 • Number of events 12 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
9.1%
2/22 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
3.8%
5/133 • Number of events 5 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
9.1%
2/22 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
20/133 • Number of events 20 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
13.6%
3/22 • Number of events 4 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
5/133 • Number of events 6 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
9.1%
2/22 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.0%
16/133 • Number of events 19 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.5%
14/133 • Number of events 16 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
0.00%
0/22 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.0%
12/133 • Number of events 17 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
7/133 • Number of events 11 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
4.5%
1/22 • Number of events 1 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/133 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
9.1%
2/22 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hypotension
|
5.3%
7/133 • Number of events 7 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
|
9.1%
2/22 • Number of events 2 • Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
TEAEs were defined as new AEs or pre-existing conditions that worsen in NCI-CTCAE grade after the first dose of study drug and up to 30 days after the last dose of study drug.
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Additional Information
Contact for Clinical Trial Information
Daiichi Sanyko, Inc
Phone: 908-992-6400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place