NCT01772472 · ADVERSE EVENTS

Adverse events

A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE) · Source last updated 2025-07-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: From signing of informed consent till the end of follow-up (up to approximately 131 months)
Other-event reporting threshold: 5%

AE(s): SE Population. All-cause mortality: ITT population.1 participant randomized to trastuzumab arm was untreated, later re-randomized to T-DM1 arm \& received treatment. Another participant in trastuzumab arm received 13 cycles of trastuzumab \& 1 of T-DM1. Both these participants were included in the trastuzumab ITT population \& T-DM1 safety analysis (SA). 1 participant in T-DM1 arm received 9 cycles of trastuzumab \& included in trastuzumab SA.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Trastuzumab Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.	58 / 720	633 / 720	126 / 743
Trastuzumab Emtansine Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.	94 / 740	719 / 740	94 / 743

Group identifiers: EG000: Trastuzumab · EG001: Trastuzumab Emtansine

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
720
num Events
1
group Id
EG001
num Affected
0
num At Risk
740
num Events
0
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
3
num At Risk
720
num Events
3
group Id
EG001
num Affected
2
num At Risk
740
num Events
2
term
CARDIAC FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
720
num Events
1
group Id
EG001
num Affected
0
num At Risk
740
num Events
0
term
CARDIOGENIC SHOCK
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
720
num Events
1
group Id
EG001
num Affected
0
num At Risk
740
num Events
0
term
PERICARDITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
720
num Events
0
group Id
EG001
num Affected
1
num At Risk
740
num Events
1
term
VISION BLURRED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
720
num Events
2
group Id
EG001
num Affected
3
num At Risk
740
num Events
3
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
720
num Events
0
group Id
EG001
num Affected
1
num At Risk
740
num Events
1
term
COLITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
720
num Events
1
group Id
EG001
num Affected
1
num At Risk
740
num Events
1
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
720
num Events
1
group Id
EG001
num Affected
0
num At Risk
740
num Events
0
term
HAEMORRHOIDS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
720
num Events
0
group Id
EG001
num Affected
1
num At Risk
740
num Events
1
term
ILEAL PERFORATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
720
num Events
0
group Id
EG001
num Affected
1
num At Risk
740
num Events
1
term
IMPAIRED GASTRIC EMPTYING
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
720
num Events
0
group Id
EG001
num Affected
1
num At Risk
740
num Events
1
term
LARGE INTESTINAL OBSTRUCTION

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
60
num At Risk
720
num Events
79
group Id
EG001
num Affected
74
num At Risk
740
num Events
90
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
13
num At Risk
720
num Events
13
group Id
EG001
num Affected
41
num At Risk
740
num Events
44
term
LACRIMATION INCREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
42
num At Risk
720
num Events
49
group Id
EG001
num Affected
55
num At Risk
740
num Events
66
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
59
num At Risk
720
num Events
66
group Id
EG001
num Affected
125
num At Risk
740
num Events
151
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
89
num At Risk
720
num Events
116
group Id
EG001
num Affected
91
num At Risk
740
num Events
117
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
9
num At Risk
720
num Events
9
group Id
EG001
num Affected
100
num At Risk
740
num Events
109
term
DRY MOUTH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
93
num At Risk
720
num Events
111
group Id
EG001
num Affected
308
num At Risk
740
num Events
441
term
NAUSEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
25
num At Risk
720
num Events
28
group Id
EG001
num Affected
80
num At Risk
740
num Events
96
term
STOMATITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
37
num At Risk
720
num Events
45
group Id
EG001
num Affected
107
num At Risk
740
num Events
140
term
VOMITING
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
14
num At Risk
720
num Events
16
group Id
EG001
num Affected
39
num At Risk
740
num Events
57
term
CHILLS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
243
num At Risk
720
num Events
276
group Id
EG001
num Affected
363
num At Risk
740
num Events
456
term
FATIGUE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
86
num At Risk
720
num Events
96
group Id
EG001
num Affected
100
num At Risk
740
num Events
138
term
INFLUENZA LIKE ILLNESS

Complete source fields

description

event Groups

deaths Num Affected
126
deaths Num At Risk
743
description
Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
id
EG000
other Num Affected
633
other Num At Risk
720
serious Num Affected
58
serious Num At Risk
720
title
Trastuzumab
deaths Num Affected
94
deaths Num At Risk
743
description
Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
id
EG001
other Num Affected
719
other Num At Risk
740
serious Num Affected
94
serious Num At Risk
740
title
Trastuzumab Emtansine

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
60
num At Risk
720
num Events
79
group Id
EG001
num Affected
74
num At Risk
740
num Events
90
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
13
num At Risk
720
num Events
13
group Id
EG001
num Affected
41
num At Risk
740
num Events
44
term
LACRIMATION INCREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
42
num At Risk
720
num Events
49
group Id
EG001
num Affected
55
num At Risk
740
num Events
66
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
59
num At Risk
720
num Events
66
group Id
EG001
num Affected
125
num At Risk
740
num Events
151
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
89
num At Risk
720
num Events
116
group Id
EG001
num Affected
91
num At Risk
740
num Events
117
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
9
num At Risk
720
num Events
9
group Id
EG001
num Affected
100
num At Risk
740
num Events
109
term
DRY MOUTH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
93
num At Risk
720
num Events
111
group Id
EG001
num Affected
308
num At Risk
740
num Events
441
term
NAUSEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
25
num At Risk
720
num Events
28
group Id
EG001
num Affected
80
num At Risk
740
num Events
96
term
STOMATITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
37
num At Risk
720
num Events
45
group Id
EG001
num Affected
107
num At Risk
740
num Events
140
term
VOMITING
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
14
num At Risk
720
num Events
16
group Id
EG001
num Affected
39
num At Risk
740
num Events
57
term
CHILLS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
243
num At Risk
720
num Events
276
group Id
EG001
num Affected
363
num At Risk
740
num Events
456
term
FATIGUE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
86
num At Risk
720
num Events
96
group Id
EG001
num Affected
100
num At Risk
740
num Events
138
term
INFLUENZA LIKE ILLNESS

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
720
num Events
1
group Id
EG001
num Affected
0
num At Risk
740
num Events
0
term
ATRIAL FIBRILLATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
3
num At Risk
720
num Events
3
group Id
EG001
num Affected
2
num At Risk
740
num Events
2
term
CARDIAC FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
720
num Events
1
group Id
EG001
num Affected
0
num At Risk
740
num Events
0
term
CARDIOGENIC SHOCK
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
720
num Events
1
group Id
EG001
num Affected
0
num At Risk
740
num Events
0
term
PERICARDITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
720
num Events
0
group Id
EG001
num Affected
1
num At Risk
740
num Events
1
term
VISION BLURRED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
720
num Events
2
group Id
EG001
num Affected
3
num At Risk
740
num Events
3
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
720
num Events
0
group Id
EG001
num Affected
1
num At Risk
740
num Events
1
term
COLITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
720
num Events
1
group Id
EG001
num Affected
1
num At Risk
740
num Events
1
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
1
num At Risk
720
num Events
1
group Id
EG001
num Affected
0
num At Risk
740
num Events
0
term
HAEMORRHOIDS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
720
num Events
0
group Id
EG001
num Affected
1
num At Risk
740
num Events
1
term
ILEAL PERFORATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
720
num Events
0
group Id
EG001
num Affected
1
num At Risk
740
num Events
1
term
IMPAIRED GASTRIC EMPTYING
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 27.0
stats
group Id
EG000
num Affected
0
num At Risk
720
num Events
0
group Id
EG001
num Affected
1
num At Risk
740
num Events
1
term
LARGE INTESTINAL OBSTRUCTION

time Frame

From signing of informed consent till the end of follow-up (up to approximately 131 months)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice