NCT00248170 · ADVERSE EVENTS

Adverse events

Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer · Source last updated 2016-04-19

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
Letrozole Letrozole	486 / 2049	1747 / 2049	Not reported / Not reported
Anastrozole Anastrozole	520 / 2062	1762 / 2062	Not reported / Not reported

Group identifiers: EG000: Letrozole · EG001: Anastrozole

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
4
num At Risk
2049
group Id
EG001
num Affected
3
num At Risk
2062
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
2049
group Id
EG001
num Affected
1
num At Risk
2062
term
Autoimmune haemolytic 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
2049
group Id
EG001
num Affected
0
num At Risk
2062
term
Haemorrhagic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
2049
group Id
EG001
num Affected
2
num At Risk
2062
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
2049
group Id
EG001
num Affected
1
num At Risk
2062
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
2049
group Id
EG001
num Affected
1
num At Risk
2062
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
3
num At Risk
2049
group Id
EG001
num Affected
4
num At Risk
2062
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
2049
group Id
EG001
num Affected
0
num At Risk
2062
term
Adams-Stokes syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
8
num At Risk
2049
group Id
EG001
num Affected
8
num At Risk
2062
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
2049
group Id
EG001
num Affected
2
num At Risk
2062
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
2049
group Id
EG001
num Affected
2
num At Risk
2062
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
19
num At Risk
2049
group Id
EG001
num Affected
15
num At Risk
2062
term
Atrial fibrillation

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
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
127
num At Risk
2049
group Id
EG001
num Affected
148
num At Risk
2062
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
345
num At Risk
2049
group Id
EG001
num Affected
341
num At Risk
2062
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
100
num At Risk
2049
group Id
EG001
num Affected
104
num At Risk
2062
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
120
num At Risk
2049
group Id
EG001
num Affected
88
num At Risk
2062
term
Radiation skin injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
155
num At Risk
2049
group Id
EG001
num Affected
151
num At Risk
2062
term
Hypercholesterolaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
983
num At Risk
2049
group Id
EG001
num Affected
983
num At Risk
2062
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
207
num At Risk
2049
group Id
EG001
num Affected
187
num At Risk
2062
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
138
num At Risk
2049
group Id
EG001
num Affected
120
num At Risk
2062
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
122
num At Risk
2049
group Id
EG001
num Affected
144
num At Risk
2062
term
Musculoskeletal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
232
num At Risk
2049
group Id
EG001
num Affected
211
num At Risk
2062
term
Myalgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
202
num At Risk
2049
group Id
EG001
num Affected
172
num At Risk
2062
term
Osteopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
221
num At Risk
2049
group Id
EG001
num Affected
224
num At Risk
2062
term
Osteoporosis

Complete source fields

event Groups

description
Letrozole
id
EG000
other Num Affected
1747
other Num At Risk
2049
serious Num Affected
486
serious Num At Risk
2049
title
Letrozole
description
Anastrozole
id
EG001
other Num Affected
1762
other Num At Risk
2062
serious Num Affected
520
serious Num At Risk
2062
title
Anastrozole

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
127
num At Risk
2049
group Id
EG001
num Affected
148
num At Risk
2062
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
345
num At Risk
2049
group Id
EG001
num Affected
341
num At Risk
2062
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
100
num At Risk
2049
group Id
EG001
num Affected
104
num At Risk
2062
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
120
num At Risk
2049
group Id
EG001
num Affected
88
num At Risk
2062
term
Radiation skin injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
155
num At Risk
2049
group Id
EG001
num Affected
151
num At Risk
2062
term
Hypercholesterolaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
983
num At Risk
2049
group Id
EG001
num Affected
983
num At Risk
2062
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
207
num At Risk
2049
group Id
EG001
num Affected
187
num At Risk
2062
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
138
num At Risk
2049
group Id
EG001
num Affected
120
num At Risk
2062
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
122
num At Risk
2049
group Id
EG001
num Affected
144
num At Risk
2062
term
Musculoskeletal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
232
num At Risk
2049
group Id
EG001
num Affected
211
num At Risk
2062
term
Myalgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
202
num At Risk
2049
group Id
EG001
num Affected
172
num At Risk
2062
term
Osteopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
221
num At Risk
2049
group Id
EG001
num Affected
224
num At Risk
2062
term
Osteoporosis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
4
num At Risk
2049
group Id
EG001
num Affected
3
num At Risk
2062
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
2049
group Id
EG001
num Affected
1
num At Risk
2062
term
Autoimmune haemolytic 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
2049
group Id
EG001
num Affected
0
num At Risk
2062
term
Haemorrhagic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
2049
group Id
EG001
num Affected
2
num At Risk
2062
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
2049
group Id
EG001
num Affected
1
num At Risk
2062
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
2049
group Id
EG001
num Affected
1
num At Risk
2062
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
3
num At Risk
2049
group Id
EG001
num Affected
4
num At Risk
2062
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
2049
group Id
EG001
num Affected
0
num At Risk
2062
term
Adams-Stokes syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
8
num At Risk
2049
group Id
EG001
num Affected
8
num At Risk
2062
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
2049
group Id
EG001
num Affected
2
num At Risk
2062
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
2049
group Id
EG001
num Affected
2
num At Risk
2062
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
19
num At Risk
2049
group Id
EG001
num Affected
15
num At Risk
2062
term
Atrial fibrillation

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