Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01] · Source last updated 2022-03-18
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
Baseline up to 47 days after last dose, up to 36 months postdose
What was measured
A treatment-emergent adverse event (TEAE) is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
Analysis population: Adverse events were assessed in the Safety Analysis Set.
Groups in this outcome
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
Physician's Choice Irinotecan
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
Physician's Choice Paclitaxel
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
Physician's Choice Overall
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
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
DS-8201a
125
Physician's Choice Irinotecan
55
Physician's Choice Paclitaxel
7
Physician's Choice Overall
62
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
20
Exploratory: Naïve HER2 IHC 1+, DS-8201a
24
Reported measurements
Any TEAE, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
125
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
54
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
7
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
61
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
20
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
24
Not reported
Not reported
Not reported
Not reported
Any TEAE, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
125
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
54
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
7
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
61
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
20
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
24
Not reported
Not reported
Not reported
Not reported
Drug-related TEAEs, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
122
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
51
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
5
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
56
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
19
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
24
Not reported
Not reported
Not reported
Not reported
Drug-related TEAEs, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
122
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
51
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
5
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
56
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
19
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
24
Not reported
Not reported
Not reported
Not reported
Serious TEAEs, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
55
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
14
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
1
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
15
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
6
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
11
Not reported
Not reported
Not reported
Not reported
Serious TEAEs, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
58
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
15
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
1
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
16
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
6
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
11
Not reported
Not reported
Not reported
Not reported
Drug-related serious TEAEs, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
27
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
5
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
5
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
1
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
6
Not reported
Not reported
Not reported
Not reported
Drug-related serious TEAEs, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
31
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
5
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
5
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
1
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
6
Not reported
Not reported
Not reported
Not reported
TEAEs associated with drug withdrawn, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
19
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
4
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
4
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
2
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
1
Not reported
Not reported
Not reported
Not reported
TEAEs associated with drug withdrawn, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
23
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
4
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
4
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
2
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
1
Not reported
Not reported
Not reported
Not reported
Drug-related TEAEs associated with drug withdrawn, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
12
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
3
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
3
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
1
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
0
Not reported
Not reported
Not reported
Not reported
Drug-related TEAEs associated with drug withdrawn, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
15
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
3
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
3
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
1
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
0
Not reported
Not reported
Not reported
Not reported
TEAEs associated with dose reduced, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
40
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
21
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
21
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
6
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
8
Not reported
Not reported
Not reported
Not reported
TEAEs associated with dose reduced, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
40
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
21
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
21
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
6
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
8
Not reported
Not reported
Not reported
Not reported
Drug-related TEAEs associated with dose reduced, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
38
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
21
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
21
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
6
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
7
Not reported
Not reported
Not reported
Not reported
Drug-related TEAEs associated with dose reduced, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
38
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
21
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
21
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
6
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
7
Not reported
Not reported
Not reported
Not reported
TEAEs associated with drug interrupted, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
78
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
20
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
3
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
23
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
8
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
10
Not reported
Not reported
Not reported
Not reported
TEAEs associated with drug interrupted, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
79
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
20
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
3
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
23
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
8
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
10
Not reported
Not reported
Not reported
Not reported
Drug-related TEAE associated with drug interrupted, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
64
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
17
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
2
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
19
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
7
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
10
Not reported
Not reported
Not reported
Not reported
Drug-related TEAE associated with drug interrupted, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
65
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
17
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
2
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
19
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
7
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
10
Not reported
Not reported
Not reported
Not reported
TEAEs associated with death, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
8
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
1
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
1
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
2
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
2
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
0
Not reported
Not reported
Not reported
Not reported
TEAEs associated with death, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
9
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
1
Not reported
Not reported
Not reported
Not reported
Physician's Choice Paclitaxel
1
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
2
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
2
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
125
group Id
OG001
value
54
group Id
OG002
value
7
group Id
OG003
value
61
group Id
OG004
value
20
group Id
OG005
value
24
title
Any TEAE, 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
125
group Id
OG001
value
54
group Id
OG002
value
7
group Id
OG003
value
61
group Id
OG004
value
20
group Id
OG005
value
24
title
Any TEAE, 36 months (DCO: Dec 11, 2020)
categories
measurements
group Id
OG000
value
122
group Id
OG001
value
51
group Id
OG002
value
5
group Id
OG003
value
56
group Id
OG004
value
19
group Id
OG005
value
24
title
Drug-related TEAEs, 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
122
group Id
OG001
value
51
group Id
OG002
value
5
group Id
OG003
value
56
group Id
OG004
value
19
group Id
OG005
value
24
title
Drug-related TEAEs, 36 months (DCO: Dec 11, 2020)
categories
measurements
group Id
OG000
value
55
group Id
OG001
value
14
group Id
OG002
value
1
group Id
OG003
value
15
group Id
OG004
value
6
group Id
OG005
value
11
title
Serious TEAEs, 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
58
group Id
OG001
value
15
group Id
OG002
value
1
group Id
OG003
value
16
group Id
OG004
value
6
group Id
OG005
value
11
title
Serious TEAEs, 36 months (DCO: Dec 11, 2020)
categories
measurements
group Id
OG000
value
27
group Id
OG001
value
5
group Id
OG002
value
0
group Id
OG003
value
5
group Id
OG004
value
1
group Id
OG005
value
6
title
Drug-related serious TEAEs, 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
31
group Id
OG001
value
5
group Id
OG002
value
0
group Id
OG003
value
5
group Id
OG004
value
1
group Id
OG005
value
6
title
Drug-related serious TEAEs, 36 months (DCO: Dec 11, 2020)
categories
measurements
group Id
OG000
value
19
group Id
OG001
value
4
group Id
OG002
value
0
group Id
OG003
value
4
group Id
OG004
value
2
group Id
OG005
value
1
title
TEAEs associated with drug withdrawn, 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
23
group Id
OG001
value
4
group Id
OG002
value
0
group Id
OG003
value
4
group Id
OG004
value
2
group Id
OG005
value
1
title
TEAEs associated with drug withdrawn, 36 months (DCO: Dec 11, 2020)
categories
measurements
group Id
OG000
value
12
group Id
OG001
value
3
group Id
OG002
value
0
group Id
OG003
value
3
group Id
OG004
value
1
group Id
OG005
value
0
title
Drug-related TEAEs associated with drug withdrawn, 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
15
group Id
OG001
value
3
group Id
OG002
value
0
group Id
OG003
value
3
group Id
OG004
value
1
group Id
OG005
value
0
title
Drug-related TEAEs associated with drug withdrawn, 36 months (DCO: Dec 11, 2020)
denoms
counts
group Id
OG000
value
125
group Id
OG001
value
55
group Id
OG002
value
7
group Id
OG003
value
62
group Id
OG004
value
20
group Id
OG005
value
24
units
Participants
description
A treatment-emergent adverse event (TEAE) is defined as an adverse event that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
groups
description
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
id
OG000
title
DS-8201a
description
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
id
OG001
title
Physician's Choice Irinotecan
description
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
id
OG002
title
Physician's Choice Paclitaxel
description
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
id
OG003
title
Physician's Choice Overall
description
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
id
OG004
title
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
description
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
id
OG005
title
Exploratory: Naïve HER2 IHC 1+, DS-8201a
param Type
COUNT_OF_PARTICIPANTS
population Description
Adverse events were assessed in the Safety Analysis Set.
reporting Status
POSTED
time Frame
Baseline up to 47 days after last dose, up to 36 months postdose
title
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (Safety Analysis Set)
Triangle