NCT00096278 · ADVERSE EVENTS

Adverse events

Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer · Source last updated 2019-07-30

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 at Risk includes any patient who submitted an Adverse Event (AE) form.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Oxaliplatin + Leucovorin + 5-Fluorouracil Oxaliplatin + Leucovorin + 5-Fluorouracil	81 / 1326	954 / 1326	Not reported / Not reported
Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab	270 / 1334	1043 / 1334	Not reported / Not reported

Group identifiers: EG000: Oxaliplatin + Leucovorin + 5-Fluorouracil · EG001: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab

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
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
1326
group Id
EG001
num Affected
3
num At Risk
1334
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
1326
group Id
EG001
num Affected
15
num At Risk
1334
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
1326
group Id
EG001
num Affected
4
num At Risk
1334
term
Acidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
1326
group Id
EG001
num Affected
0
num At Risk
1334
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
1326
group Id
EG001
num Affected
1
num At Risk
1334
term
Adult respiratory distress syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
1326
group Id
EG001
num Affected
3
num At Risk
1334
term
Alanine aminotransferase increased (ALT/SGPT)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
1326
group Id
EG001
num Affected
1
num At Risk
1334
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
3
num At Risk
1326
group Id
EG001
num Affected
3
num At Risk
1334
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
1326
group Id
EG001
num Affected
3
num At Risk
1334
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
1326
group Id
EG001
num Affected
1
num At Risk
1334
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
1326
group Id
EG001
num Affected
0
num At Risk
1334
term
Appendicitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
1326
group Id
EG001
num Affected
0
num At Risk
1334
term
Appendicitis perforated

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
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
53
num At Risk
1326
group Id
EG001
num Affected
67
num At Risk
1334
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
53
num At Risk
1326
group Id
EG001
num Affected
70
num At Risk
1334
term
Depression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
128
num At Risk
1326
group Id
EG001
num Affected
153
num At Risk
1334
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
98
num At Risk
1326
group Id
EG001
num Affected
122
num At Risk
1334
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
24
num At Risk
1326
group Id
EG001
num Affected
172
num At Risk
1334
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
433
num At Risk
1326
group Id
EG001
num Affected
400
num At Risk
1334
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
586
num At Risk
1326
group Id
EG001
num Affected
660
num At Risk
1334
term
Peripheral sensory neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
64
num At Risk
1326
group Id
EG001
num Affected
85
num At Risk
1334
term
Thromboembolic event
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
73
num At Risk
1326
group Id
EG001
num Affected
58
num At Risk
1334
term
White blood cell decreased

Complete source fields

description

Participants at Risk includes any patient who submitted an Adverse Event (AE) form.

event Groups

description
Oxaliplatin + Leucovorin + 5-Fluorouracil
id
EG000
other Num Affected
954
other Num At Risk
1326
serious Num Affected
81
serious Num At Risk
1326
title
Oxaliplatin + Leucovorin + 5-Fluorouracil
description
Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
id
EG001
other Num Affected
1043
other Num At Risk
1334
serious Num Affected
270
serious Num At Risk
1334
title
Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
53
num At Risk
1326
group Id
EG001
num Affected
67
num At Risk
1334
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
53
num At Risk
1326
group Id
EG001
num Affected
70
num At Risk
1334
term
Depression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
128
num At Risk
1326
group Id
EG001
num Affected
153
num At Risk
1334
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
98
num At Risk
1326
group Id
EG001
num Affected
122
num At Risk
1334
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
24
num At Risk
1326
group Id
EG001
num Affected
172
num At Risk
1334
term
Hypertension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
433
num At Risk
1326
group Id
EG001
num Affected
400
num At Risk
1334
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
586
num At Risk
1326
group Id
EG001
num Affected
660
num At Risk
1334
term
Peripheral sensory neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
64
num At Risk
1326
group Id
EG001
num Affected
85
num At Risk
1334
term
Thromboembolic event
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
73
num At Risk
1326
group Id
EG001
num Affected
58
num At Risk
1334
term
White blood cell decreased

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
1326
group Id
EG001
num Affected
3
num At Risk
1334
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
1326
group Id
EG001
num Affected
15
num At Risk
1334
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
1326
group Id
EG001
num Affected
4
num At Risk
1334
term
Acidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
1326
group Id
EG001
num Affected
0
num At Risk
1334
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
2
num At Risk
1326
group Id
EG001
num Affected
1
num At Risk
1334
term
Adult respiratory distress syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
1326
group Id
EG001
num Affected
3
num At Risk
1334
term
Alanine aminotransferase increased (ALT/SGPT)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
1326
group Id
EG001
num Affected
1
num At Risk
1334
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
3
num At Risk
1326
group Id
EG001
num Affected
3
num At Risk
1334
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
1326
group Id
EG001
num Affected
3
num At Risk
1334
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
0
num At Risk
1326
group Id
EG001
num Affected
1
num At Risk
1334
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
1326
group Id
EG001
num Affected
0
num At Risk
1334
term
Appendicitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v4.0
stats
group Id
EG000
num Affected
1
num At Risk
1326
group Id
EG001
num Affected
0
num At Risk
1334
term
Appendicitis perforated

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Preserved source evidence · Not medical advice