NCT01007942 · ADVERSE EVENTS

Adverse events

Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer · Source last updated 2017-04-05

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: Not reported
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Everolimus + Trastuzumab + Vinorelbine Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)	122 / 280	280 / 280	Not reported / Not reported
Placebo + Trastuzumab + Vinorelbine Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)	58 / 282	280 / 282	Not reported / Not reported

Group identifiers: EG000: Everolimus + Trastuzumab + Vinorelbine · EG001: Placebo + Trastuzumab + Vinorelbine

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
0
num At Risk
280
group Id
EG001
num Affected
1
num At Risk
282
term
Agranulocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
10
num At Risk
280
group Id
EG001
num Affected
2
num At Risk
282
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
30
num At Risk
280
group Id
EG001
num Affected
4
num At Risk
282
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
1
num At Risk
280
group Id
EG001
num Affected
0
num At Risk
282
term
Immune thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
3
num At Risk
280
group Id
EG001
num Affected
0
num At Risk
282
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
12
num At Risk
280
group Id
EG001
num Affected
3
num At Risk
282
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
4
num At Risk
280
group Id
EG001
num Affected
1
num At Risk
282
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
1
num At Risk
280
group Id
EG001
num Affected
0
num At Risk
282
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
1
num At Risk
280
group Id
EG001
num Affected
0
num At Risk
282
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
2
num At Risk
280
group Id
EG001
num Affected
1
num At Risk
282
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
0
num At Risk
280
group Id
EG001
num Affected
1
num At Risk
282
term
Cataract subcapsular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
1
num At Risk
280
group Id
EG001
num Affected
0
num At Risk
282
term
Vision blurred

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 V18.0
stats
group Id
EG000
num Affected
137
num At Risk
280
group Id
EG001
num Affected
85
num At Risk
282
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
17
num At Risk
280
group Id
EG001
num Affected
7
num At Risk
282
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
126
num At Risk
280
group Id
EG001
num Affected
105
num At Risk
282
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
226
num At Risk
280
group Id
EG001
num Affected
196
num At Risk
282
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
39
num At Risk
280
group Id
EG001
num Affected
6
num At Risk
282
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
45
num At Risk
280
group Id
EG001
num Affected
52
num At Risk
282
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
34
num At Risk
280
group Id
EG001
num Affected
40
num At Risk
282
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
84
num At Risk
280
group Id
EG001
num Affected
88
num At Risk
282
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
108
num At Risk
280
group Id
EG001
num Affected
88
num At Risk
282
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
14
num At Risk
280
group Id
EG001
num Affected
7
num At Risk
282
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
21
num At Risk
280
group Id
EG001
num Affected
25
num At Risk
282
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
32
num At Risk
280
group Id
EG001
num Affected
6
num At Risk
282
term
Mouth ulceration

Complete source fields

event Groups

description
Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
id
EG000
other Num Affected
280
other Num At Risk
280
serious Num Affected
122
serious Num At Risk
280
title
Everolimus + Trastuzumab + Vinorelbine
description
Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
id
EG001
other Num Affected
280
other Num At Risk
282
serious Num Affected
58
serious Num At Risk
282
title
Placebo + Trastuzumab + Vinorelbine

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
137
num At Risk
280
group Id
EG001
num Affected
85
num At Risk
282
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
17
num At Risk
280
group Id
EG001
num Affected
7
num At Risk
282
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
126
num At Risk
280
group Id
EG001
num Affected
105
num At Risk
282
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
226
num At Risk
280
group Id
EG001
num Affected
196
num At Risk
282
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
39
num At Risk
280
group Id
EG001
num Affected
6
num At Risk
282
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
45
num At Risk
280
group Id
EG001
num Affected
52
num At Risk
282
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
34
num At Risk
280
group Id
EG001
num Affected
40
num At Risk
282
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
84
num At Risk
280
group Id
EG001
num Affected
88
num At Risk
282
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
108
num At Risk
280
group Id
EG001
num Affected
88
num At Risk
282
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
14
num At Risk
280
group Id
EG001
num Affected
7
num At Risk
282
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
21
num At Risk
280
group Id
EG001
num Affected
25
num At Risk
282
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
32
num At Risk
280
group Id
EG001
num Affected
6
num At Risk
282
term
Mouth ulceration

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
0
num At Risk
280
group Id
EG001
num Affected
1
num At Risk
282
term
Agranulocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
10
num At Risk
280
group Id
EG001
num Affected
2
num At Risk
282
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
30
num At Risk
280
group Id
EG001
num Affected
4
num At Risk
282
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
1
num At Risk
280
group Id
EG001
num Affected
0
num At Risk
282
term
Immune thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
3
num At Risk
280
group Id
EG001
num Affected
0
num At Risk
282
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
12
num At Risk
280
group Id
EG001
num Affected
3
num At Risk
282
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
4
num At Risk
280
group Id
EG001
num Affected
1
num At Risk
282
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
1
num At Risk
280
group Id
EG001
num Affected
0
num At Risk
282
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
1
num At Risk
280
group Id
EG001
num Affected
0
num At Risk
282
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
2
num At Risk
280
group Id
EG001
num Affected
1
num At Risk
282
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
0
num At Risk
280
group Id
EG001
num Affected
1
num At Risk
282
term
Cataract subcapsular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA V18.0
stats
group Id
EG000
num Affected
1
num At Risk
280
group Id
EG001
num Affected
0
num At Risk
282
term
Vision blurred

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