NCT01208103 · ADVERSE EVENTS

Adverse events

Bevacizumab, Capecitabine, and Oxaliplatin in Treating Advanced Small Intestinal or Ampulla of Vater Adenocarcinoma · Source last updated 2020-09-03

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: Assessed up to 67 months
Other-event reporting threshold: 3.3%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Bevacizumab + Capecitabine + Oxaliplatin Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.	4 / 30	30 / 30	30 / 30

Group identifiers: EG000: Bevacizumab + Capecitabine + Oxaliplatin

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Upper gastrointestinal hemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Non-cardiac chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Abdominal pain

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
17
num At Risk
30
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
14
num At Risk
30
term
Platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
11
num At Risk
30
term
Neutrophil count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
7
num At Risk
30
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
16
num At Risk
30
term
Alanine aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
7
num At Risk
30
term
Alkaline phosphatase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
23
num At Risk
30
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Ascites
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
21
num At Risk
30
term
Aspartate
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
6
num At Risk
30
term
Blood bilirubin increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Creatinine increased

Complete source fields

event Groups

deaths Num Affected
30
deaths Num At Risk
30
description
Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
id
EG000
other Num Affected
30
other Num At Risk
30
serious Num Affected
4
serious Num At Risk
30
title
Bevacizumab + Capecitabine + Oxaliplatin

frequency Threshold

3.3

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
17
num At Risk
30
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
14
num At Risk
30
term
Platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
11
num At Risk
30
term
Neutrophil count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
7
num At Risk
30
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
16
num At Risk
30
term
Alanine aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
7
num At Risk
30
term
Alkaline phosphatase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
23
num At Risk
30
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Ascites
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
21
num At Risk
30
term
Aspartate
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
6
num At Risk
30
term
Blood bilirubin increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
30
term
Creatinine increased

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Upper gastrointestinal hemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Non-cardiac chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
30
term
Abdominal pain

time Frame

Assessed up to 67 months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice