Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term 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.
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
Nausea, 25 months (DCO: Nov 8, 2019)
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
27
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
29
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
11
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
19
Not reported
Not reported
Not reported
Not reported
Nausea, 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
27
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
29
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
11
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
19
Not reported
Not reported
Not reported
Not reported
Decreased appetite, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
75
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
27
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
28
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
13
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
18
Not reported
Not reported
Not reported
Not reported
Decreased appetite, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
76
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
27
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
28
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
13
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
18
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
77
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
18
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
21
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
12
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased, 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
18
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
21
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
12
Not reported
Not reported
Not reported
Not reported
Anaemia, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
71
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
10
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
10
Not reported
Not reported
Not reported
Not reported
Anaemia, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
71
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
10
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
11
Not reported
Not reported
Not reported
Not reported
White blood cell count decreased, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
47
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
18
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
21
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
4
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
7
Not reported
Not reported
Not reported
Not reported
White blood cell count decreased, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
49
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
18
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
21
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
4
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
7
Not reported
Not reported
Not reported
Not reported
Platelet count decreased, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
47
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
3
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
7
Not reported
Not reported
Not reported
Not reported
Platelet count decreased, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
48
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
3
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
7
Not reported
Not reported
Not reported
Not reported
Malaise, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
43
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
9
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
10
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
4
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
9
Not reported
Not reported
Not reported
Not reported
Malaise, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
44
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
9
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
10
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
4
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
9
Not reported
Not reported
Not reported
Not reported
Diarrhoea, 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
20
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
20
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
Diarrhoea, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
41
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
0
Not reported
Not reported
Not reported
Not reported
Physician's Choice Overall
20
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
Vomiting, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
33
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
4
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
7
Not reported
Not reported
Not reported
Not reported
Vomiting, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
33
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
4
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
7
Not reported
Not reported
Not reported
Not reported
Constipation, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
30
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
13
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
14
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
5
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
5
Not reported
Not reported
Not reported
Not reported
Constipation, 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
13
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
15
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
5
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
5
Not reported
Not reported
Not reported
Not reported
Pyrexia, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
30
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
8
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
10
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
3
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
6
Not reported
Not reported
Not reported
Not reported
Pyrexia, 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
8
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
10
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
3
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
6
Not reported
Not reported
Not reported
Not reported
Fatigue, 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
15
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
15
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
5
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
6
Not reported
Not reported
Not reported
Not reported
Fatigue, 36 months (DCO: Dec 11, 2020)
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
15
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
15
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
5
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
6
Not reported
Not reported
Not reported
Not reported
Alopecia, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
28
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
8
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
9
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
3
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
1
Not reported
Not reported
Not reported
Not reported
Alopecia, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
28
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
8
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
9
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
3
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
1
Not reported
Not reported
Not reported
Not reported
Lymphocyte count decreased, 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
2
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
2
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
3
Not reported
Not reported
Not reported
Not reported
Lymphocyte count decreased, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
30
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
2
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
2
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
3
Not reported
Not reported
Not reported
Not reported
Weight decreased, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
17
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
4
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
7
Not reported
Not reported
Not reported
Not reported
Weight decreased, 36 months (DCO: Dec 11, 2020)
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
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
4
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
7
Not reported
Not reported
Not reported
Not reported
Hypoalbuminaemia, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
18
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
7
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
8
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
5
Not reported
Not reported
Not reported
Not reported
Hypoalbuminaemia, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
18
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
7
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
8
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
5
Not reported
Not reported
Not reported
Not reported
Oedema peripheral, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
13
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
0
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
0
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
4
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
1
Not reported
Not reported
Not reported
Not reported
Oedema peripheral, 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
0
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
0
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
4
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
2
Not reported
Not reported
Not reported
Not reported
Dysgeusia, 25 months (DCO: Nov 8, 2019)
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
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
4
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
1
Not reported
Not reported
Not reported
Not reported
Dysgeusia, 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
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
4
Not reported
Not reported
Not reported
Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a
1
Not reported
Not reported
Not reported
Not reported
Peripheral sensory neuropathy, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
4
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
0
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
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
Peripheral sensory neuropathy, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
DS-8201a
4
Not reported
Not reported
Not reported
Not reported
Physician's Choice Irinotecan
0
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
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
79
group Id
OG001
value
27
group Id
OG002
value
2
group Id
OG003
value
29
group Id
OG004
value
11
group Id
OG005
value
19
title
Nausea, 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
79
group Id
OG001
value
27
group Id
OG002
value
2
group Id
OG003
value
29
group Id
OG004
value
11
group Id
OG005
value
19
title
Nausea, 36 months (DCO: Dec 11, 2020)
categories
measurements
group Id
OG000
value
75
group Id
OG001
value
27
group Id
OG002
value
1
group Id
OG003
value
28
group Id
OG004
value
13
group Id
OG005
value
18
title
Decreased appetite, 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
76
group Id
OG001
value
27
group Id
OG002
value
1
group Id
OG003
value
28
group Id
OG004
value
13
group Id
OG005
value
18
title
Decreased appetite, 36 months (DCO: Dec 11, 2020)
categories
measurements
group Id
OG000
value
77
group Id
OG001
value
18
group Id
OG002
value
3
group Id
OG003
value
21
group Id
OG004
value
8
group Id
OG005
value
12
title
Neutrophil count decreased, 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
79
group Id
OG001
value
18
group Id
OG002
value
3
group Id
OG003
value
21
group Id
OG004
value
8
group Id
OG005
value
12
title
Neutrophil count decreased, 36 months (DCO: Dec 11, 2020)
categories
measurements
group Id
OG000
value
71
group Id
OG001
value
17
group Id
OG002
value
2
group Id
OG003
value
19
group Id
OG004
value
10
group Id
OG005
value
10
title
Anaemia, 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
71
group Id
OG001
value
17
group Id
OG002
value
2
group Id
OG003
value
19
group Id
OG004
value
10
group Id
OG005
value
11
title
Anaemia, 36 months (DCO: Dec 11, 2020)
categories
measurements
group Id
OG000
value
47
group Id
OG001
value
18
group Id
OG002
value
3
group Id
OG003
value
21
group Id
OG004
value
4
group Id
OG005
value
7
title
White blood cell count decreased, 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
49
group Id
OG001
value
18
group Id
OG002
value
3
group Id
OG003
value
21
group Id
OG004
value
4
group Id
OG005
value
7
title
White blood cell count decreased, 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.
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
Summary of Most Common Treatment-Emergent Adverse Events (TEAEs) ≥20% of Any Grade by Preferred Term Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Safety Analysis Set)
Triangle