NCT00863655 · ADVERSE EVENTS

Adverse events

Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole · Source last updated 2017-05-02

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%

4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Everolimus + Exemestane Everolimus 10 mg daily in combination with exemestane 25 mg daily	158 / 482	479 / 482	Not reported / Not reported
Placebo + Exemestane Placebo of everolimus in combination with exemestane 25 mg daily	37 / 238	209 / 238	Not reported / Not reported

Group identifiers: EG000: Everolimus + Exemestane · EG001: Placebo + Exemestane

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
stats
group Id
EG000
num Affected
7
num At Risk
482
group Id
EG001
num Affected
2
num At Risk
238
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
482
group Id
EG001
num Affected
0
num At Risk
238
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
482
group Id
EG001
num Affected
1
num At Risk
238
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
482
group Id
EG001
num Affected
1
num At Risk
238
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
482
group Id
EG001
num Affected
0
num At Risk
238
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
482
group Id
EG001
num Affected
0
num At Risk
238
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
482
group Id
EG001
num Affected
0
num At Risk
238
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
482
group Id
EG001
num Affected
0
num At Risk
238
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
482
group Id
EG001
num Affected
0
num At Risk
238
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
482
group Id
EG001
num Affected
1
num At Risk
238
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
482
group Id
EG001
num Affected
0
num At Risk
238
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
482
group Id
EG001
num Affected
0
num At Risk
238
term
Cardiopulmonary failure

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
stats
group Id
EG000
num Affected
93
num At Risk
482
group Id
EG001
num Affected
9
num At Risk
238
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
27
num At Risk
482
group Id
EG001
num Affected
3
num At Risk
238
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
39
num At Risk
482
group Id
EG001
num Affected
3
num At Risk
238
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
61
num At Risk
482
group Id
EG001
num Affected
1
num At Risk
238
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
34
num At Risk
482
group Id
EG001
num Affected
7
num At Risk
238
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
67
num At Risk
482
group Id
EG001
num Affected
31
num At Risk
238
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
157
num At Risk
482
group Id
EG001
num Affected
44
num At Risk
238
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
51
num At Risk
482
group Id
EG001
num Affected
16
num At Risk
238
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
138
num At Risk
482
group Id
EG001
num Affected
65
num At Risk
238
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
281
num At Risk
482
group Id
EG001
num Affected
26
num At Risk
238
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
75
num At Risk
482
group Id
EG001
num Affected
27
num At Risk
238
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
63
num At Risk
482
group Id
EG001
num Affected
9
num At Risk
238
term
Asthenia

Complete source fields

description

event Groups

description
Everolimus 10 mg daily in combination with exemestane 25 mg daily
id
EG000
other Num Affected
479
other Num At Risk
482
serious Num Affected
158
serious Num At Risk
482
title
Everolimus + Exemestane
description
Placebo of everolimus in combination with exemestane 25 mg daily
id
EG001
other Num Affected
209
other Num At Risk
238
serious Num Affected
37
serious Num At Risk
238
title
Placebo + Exemestane

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
93
num At Risk
482
group Id
EG001
num Affected
9
num At Risk
238
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
27
num At Risk
482
group Id
EG001
num Affected
3
num At Risk
238
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
39
num At Risk
482
group Id
EG001
num Affected
3
num At Risk
238
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
61
num At Risk
482
group Id
EG001
num Affected
1
num At Risk
238
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
34
num At Risk
482
group Id
EG001
num Affected
7
num At Risk
238
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
67
num At Risk
482
group Id
EG001
num Affected
31
num At Risk
238
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
157
num At Risk
482
group Id
EG001
num Affected
44
num At Risk
238
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
51
num At Risk
482
group Id
EG001
num Affected
16
num At Risk
238
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
138
num At Risk
482
group Id
EG001
num Affected
65
num At Risk
238
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
281
num At Risk
482
group Id
EG001
num Affected
26
num At Risk
238
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
75
num At Risk
482
group Id
EG001
num Affected
27
num At Risk
238
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
63
num At Risk
482
group Id
EG001
num Affected
9
num At Risk
238
term
Asthenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
7
num At Risk
482
group Id
EG001
num Affected
2
num At Risk
238
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
482
group Id
EG001
num Affected
0
num At Risk
238
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
482
group Id
EG001
num Affected
1
num At Risk
238
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
482
group Id
EG001
num Affected
1
num At Risk
238
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
482
group Id
EG001
num Affected
0
num At Risk
238
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
482
group Id
EG001
num Affected
0
num At Risk
238
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
482
group Id
EG001
num Affected
0
num At Risk
238
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
482
group Id
EG001
num Affected
0
num At Risk
238
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
482
group Id
EG001
num Affected
0
num At Risk
238
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
482
group Id
EG001
num Affected
1
num At Risk
238
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
482
group Id
EG001
num Affected
0
num At Risk
238
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
482
group Id
EG001
num Affected
0
num At Risk
238
term
Cardiopulmonary failure

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