Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Safety Analysis Set)
A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1) · Source last updated 2025-06-26
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Day 0 to Day 47 post last dose
What was measured
TEAEs were assessed by severity and seriousness according to unique criteria. Severity described the intensity of an event and was graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL; Grade 4: Life-threatening consequences; urgent intervention indicated; and Grade 5: Death related to AE. Serious TEAEs were defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires inpatient hospitalization, or causes prolongation of existing hospitalization.
Analysis population: Adverse event data were assessed in the Safety Analysis Set t data cut-off date of 21 March 2019.
Groups in this outcome
Part 1: DS-8201a Low Dose
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
Part 1: DS-8201a Medium Dose
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
Part 1: DS-8201a High Dose
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
Part 2a: DS-8201a Low Dose
All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in the continuation phase.
Part 2b (Exploratory): DS-8201a Low Dose
All participants who were T-DM1 intolerant and treated at the recommend dose (5.4 mg/kg) in the continuation phase.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Part 1: DS-8201a Low Dose
50
Part 1: DS-8201a Medium Dose
48
Part 1: DS-8201a High Dose
21
Part 2a: DS-8201a Low Dose
130
Part 2b (Exploratory): DS-8201a Low Dose
4
Reported measurements
Any TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: DS-8201a Low Dose
50
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a Medium Dose
48
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a High Dose
21
Not reported
Not reported
Not reported
Not reported
Part 2a: DS-8201a Low Dose
129
Not reported
Not reported
Not reported
Not reported
Part 2b (Exploratory): DS-8201a Low Dose
4
Not reported
Not reported
Not reported
Not reported
Drug-related TEAEs
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: DS-8201a Low Dose
50
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a Medium Dose
47
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a High Dose
21
Not reported
Not reported
Not reported
Not reported
Part 2a: DS-8201a Low Dose
128
Not reported
Not reported
Not reported
Not reported
Part 2b (Exploratory): DS-8201a Low Dose
4
Not reported
Not reported
Not reported
Not reported
Drug-related TEAEs of CTCAE ≥Grade 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: DS-8201a Low Dose
26
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a Medium Dose
32
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a High Dose
16
Not reported
Not reported
Not reported
Not reported
Part 2a: DS-8201a Low Dose
48
Not reported
Not reported
Not reported
Not reported
Part 2b (Exploratory): DS-8201a Low Dose
3
Not reported
Not reported
Not reported
Not reported
Any serious TEAE
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: DS-8201a Low Dose
11
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a Medium Dose
6
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a High Dose
8
Not reported
Not reported
Not reported
Not reported
Part 2a: DS-8201a Low Dose
25
Not reported
Not reported
Not reported
Not reported
Part 2b (Exploratory): DS-8201a Low Dose
0
Not reported
Not reported
Not reported
Not reported
Drug-related serious TEAEs
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: DS-8201a Low Dose
6
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a Medium Dose
4
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a High Dose
5
Not reported
Not reported
Not reported
Not reported
Part 2a: DS-8201a Low Dose
10
Not reported
Not reported
Not reported
Not reported
Part 2b (Exploratory): DS-8201a Low Dose
0
Not reported
Not reported
Not reported
Not reported
TEAEs associated with drug discontinuation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: DS-8201a Low Dose
6
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a Medium Dose
6
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a High Dose
8
Not reported
Not reported
Not reported
Not reported
Part 2a: DS-8201a Low Dose
8
Not reported
Not reported
Not reported
Not reported
Part 2b (Exploratory): DS-8201a Low Dose
1
Not reported
Not reported
Not reported
Not reported
Related TEAEs associated with drug discontinuation
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: DS-8201a Low Dose
6
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a Medium Dose
6
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a High Dose
8
Not reported
Not reported
Not reported
Not reported
Part 2a: DS-8201a Low Dose
7
Not reported
Not reported
Not reported
Not reported
Part 2b (Exploratory): DS-8201a Low Dose
1
Not reported
Not reported
Not reported
Not reported
TEAEs associated with dose reduction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: DS-8201a Low Dose
13
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a Medium Dose
19
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a High Dose
11
Not reported
Not reported
Not reported
Not reported
Part 2a: DS-8201a Low Dose
21
Not reported
Not reported
Not reported
Not reported
Part 2b (Exploratory): DS-8201a Low Dose
3
Not reported
Not reported
Not reported
Not reported
Drug-related TEAEs associated with dose reduction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: DS-8201a Low Dose
11
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a Medium Dose
18
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a High Dose
11
Not reported
Not reported
Not reported
Not reported
Part 2a: DS-8201a Low Dose
20
Not reported
Not reported
Not reported
Not reported
Part 2b (Exploratory): DS-8201a Low Dose
3
Not reported
Not reported
Not reported
Not reported
TEAEs associated with dose interruption
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: DS-8201a Low Dose
19
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a Medium Dose
16
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a High Dose
12
Not reported
Not reported
Not reported
Not reported
Part 2a: DS-8201a Low Dose
36
Not reported
Not reported
Not reported
Not reported
Part 2b (Exploratory): DS-8201a Low Dose
2
Not reported
Not reported
Not reported
Not reported
Related TEAEs associated with drug interruption
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: DS-8201a Low Dose
17
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a Medium Dose
13
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a High Dose
11
Not reported
Not reported
Not reported
Not reported
Part 2a: DS-8201a Low Dose
29
Not reported
Not reported
Not reported
Not reported
Part 2b (Exploratory): DS-8201a Low Dose
2
Not reported
Not reported
Not reported
Not reported
TEAEs associated with death
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: DS-8201a Low Dose
1
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a Medium Dose
1
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a High Dose
2
Not reported
Not reported
Not reported
Not reported
Part 2a: DS-8201a Low Dose
8
Not reported
Not reported
Not reported
Not reported
Part 2b (Exploratory): DS-8201a Low Dose
0
Not reported
Not reported
Not reported
Not reported
Drug-related TEAEs associated with death
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1: DS-8201a Low Dose
0
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a Medium Dose
0
Not reported
Not reported
Not reported
Not reported
Part 1: DS-8201a High Dose
1
Not reported
Not reported
Not reported
Not reported
Part 2a: DS-8201a Low Dose
2
Not reported
Not reported
Not reported
Not reported
Part 2b (Exploratory): DS-8201a Low Dose
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
50
group Id
OG001
value
48
group Id
OG002
value
21
group Id
OG003
value
129
group Id
OG004
value
4
title
Any TEAE
categories
measurements
group Id
OG000
value
50
group Id
OG001
value
47
group Id
OG002
value
21
group Id
OG003
value
128
group Id
OG004
value
4
title
Drug-related TEAEs
categories
measurements
group Id
OG000
value
26
group Id
OG001
value
32
group Id
OG002
value
16
group Id
OG003
value
48
group Id
OG004
value
3
title
Drug-related TEAEs of CTCAE ≥Grade 3
categories
measurements
group Id
OG000
value
11
group Id
OG001
value
6
group Id
OG002
value
8
group Id
OG003
value
25
group Id
OG004
value
0
title
Any serious TEAE
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
4
group Id
OG002
value
5
group Id
OG003
value
10
group Id
OG004
value
0
title
Drug-related serious TEAEs
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
6
group Id
OG002
value
8
group Id
OG003
value
8
group Id
OG004
value
1
title
TEAEs associated with drug discontinuation
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
6
group Id
OG002
value
8
group Id
OG003
value
7
group Id
OG004
value
1
title
Related TEAEs associated with drug discontinuation
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
19
group Id
OG002
value
11
group Id
OG003
value
21
group Id
OG004
value
3
title
TEAEs associated with dose reduction
categories
measurements
group Id
OG000
value
11
group Id
OG001
value
18
group Id
OG002
value
11
group Id
OG003
value
20
group Id
OG004
value
3
title
Drug-related TEAEs associated with dose reduction
categories
measurements
group Id
OG000
value
19
group Id
OG001
value
16
group Id
OG002
value
12
group Id
OG003
value
36
group Id
OG004
value
2
title
TEAEs associated with dose interruption
categories
measurements
group Id
OG000
value
17
group Id
OG001
value
13
group Id
OG002
value
11
group Id
OG003
value
29
group Id
OG004
value
2
title
Related TEAEs associated with drug interruption
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
2
group Id
OG003
value
8
group Id
OG004
value
0
title
TEAEs associated with death
denoms
counts
group Id
OG000
value
50
group Id
OG001
value
48
group Id
OG002
value
21
group Id
OG003
value
130
group Id
OG004
value
4
units
Participants
description
TEAEs were assessed by severity and seriousness according to unique criteria. Severity described the intensity of an event and was graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL; Grade 4: Life-threatening consequences; urgent intervention indicated; and Grade 5: Death related to AE. Serious TEAEs were defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires inpatient hospitalization, or causes prolongation of existing hospitalization.
groups
description
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
id
OG000
title
Part 1: DS-8201a Low Dose
description
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
id
OG001
title
Part 1: DS-8201a Medium Dose
description
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
id
OG002
title
Part 1: DS-8201a High Dose
description
All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in the continuation phase.
id
OG003
title
Part 2a: DS-8201a Low Dose
description
All participants who were T-DM1 intolerant and treated at the recommend dose (5.4 mg/kg) in the continuation phase.
id
OG004
title
Part 2b (Exploratory): DS-8201a Low Dose
param Type
COUNT_OF_PARTICIPANTS
population Description
Adverse event data were assessed in the Safety Analysis Set t data cut-off date of 21 March 2019.
reporting Status
POSTED
time Frame
Day 0 to Day 47 post last dose
title
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Safety Analysis Set)
Triangle