NCT02912559 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair · Source last updated 2026-10-01

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: 5 years
Other-event reporting threshold: 0%

All patients included in mortality assessment; only patients that received treatment included in adverse event reporting

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I (Combination Chemotherapy, Atezolizumab) Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, beginning in cycle 1 or 2. Treatment repeats every 14 days for up to 25 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial. \> \> Atezolizumab: Given IV \> * Biospecimen Collection: Undergo blood sample collection \> * Computed Tomography: Undergo CT \> * Fluorouracil: Given IV \> * Leucovorin Calcium: Given IV \> * Magnetic Resonance Imaging: Undergo MRI \> * Oxaliplatin: Given IV \> * Quality-of-Life Assessment: Ancillary studies	197 / 346	346 / 346	31 / 355
Arm II (Combination Chemotherapy) Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial. \> * Biospecimen Collection: Undergo blood sample collection \> * Computed Tomography: Undergo CT \> * Fluorouracil: Given IV \> * Leucovorin Calcium: Given IV \> * Magnetic Resonance Imaging: Undergo MRI \> * Oxaliplatin: Given IV \> * Quality-of-Life Assessment: Ancillary studies	138 / 334	324 / 334	33 / 357

Group identifiers: EG000: Arm I (Combination Chemotherapy, Atezolizumab) · EG001: Arm II (Combination Chemotherapy)

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 12.1
stats
group Id
EG000
num Affected
1
num At Risk
346
num Events
2
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Blood and lymph sys disorders - Oth Spec
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
3
num At Risk
346
num Events
3
group Id
EG001
num Affected
5
num At Risk
334
num Events
5
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
4
num At Risk
346
num Events
6
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
5
num At Risk
346
num Events
5
group Id
EG001
num Affected
2
num At Risk
334
num Events
2
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
346
num Events
1
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
346
num Events
1
group Id
EG001
num Affected
2
num At Risk
334
num Events
2
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
346
num Events
0
group Id
EG001
num Affected
1
num At Risk
334
num Events
1
term
Cardiac disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
8
num At Risk
346
num Events
8
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Chest pain - cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
4
num At Risk
346
num Events
4
group Id
EG001
num Affected
1
num At Risk
334
num Events
1
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
3
num At Risk
346
num Events
3
group Id
EG001
num Affected
2
num At Risk
334
num Events
2
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
346
num Events
0
group Id
EG001
num Affected
1
num At Risk
334
num Events
1
term
Restrictive cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
2
num At Risk
346
num Events
2
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Sinus tachycardia

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 12.1
stats
group Id
EG000
num Affected
161
num At Risk
346
num Events
1549
group Id
EG001
num Affected
148
num At Risk
334
num Events
1051
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
9
num At Risk
346
num Events
78
group Id
EG001
num Affected
8
num At Risk
334
num Events
45
term
Blood and lymph sys disorders - Oth Spec
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
3
num At Risk
346
num Events
13
group Id
EG001
num Affected
1
num At Risk
334
num Events
1
term
Eosinophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
346
num Events
1
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
346
num Events
1
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
3
num At Risk
346
num Events
6
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
2
num At Risk
346
num Events
2
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
2
num At Risk
346
num Events
19
group Id
EG001
num Affected
2
num At Risk
334
num Events
4
term
Cardiac disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
4
num At Risk
346
num Events
5
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Chest pain - cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
346
num Events
1
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
3
num At Risk
346
num Events
14
group Id
EG001
num Affected
2
num At Risk
334
num Events
3
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
346
num Events
1
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Sick sinus syndrome

Complete source fields

description

All patients included in mortality assessment; only patients that received treatment included in adverse event reporting

event Groups

deaths Num Affected
31
deaths Num At Risk
355
description
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, beginning in cycle 1 or 2. Treatment repeats every 14 days for up to 25 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial. \> \> Atezolizumab: Given IV \> * Biospecimen Collection: Undergo blood sample collection \> * Computed Tomography: Undergo CT \> * Fluorouracil: Given IV \> * Leucovorin Calcium: Given IV \> * Magnetic Resonance Imaging: Undergo MRI \> * Oxaliplatin: Given IV \> * Quality-of-Life Assessment: Ancillary studies
id
EG000
other Num Affected
346
other Num At Risk
346
serious Num Affected
197
serious Num At Risk
346
title
Arm I (Combination Chemotherapy, Atezolizumab)
deaths Num Affected
33
deaths Num At Risk
357
description
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial. \> * Biospecimen Collection: Undergo blood sample collection \> * Computed Tomography: Undergo CT \> * Fluorouracil: Given IV \> * Leucovorin Calcium: Given IV \> * Magnetic Resonance Imaging: Undergo MRI \> * Oxaliplatin: Given IV \> * Quality-of-Life Assessment: Ancillary studies
id
EG001
other Num Affected
324
other Num At Risk
334
serious Num Affected
138
serious Num At Risk
334
title
Arm II (Combination Chemotherapy)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
161
num At Risk
346
num Events
1549
group Id
EG001
num Affected
148
num At Risk
334
num Events
1051
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
9
num At Risk
346
num Events
78
group Id
EG001
num Affected
8
num At Risk
334
num Events
45
term
Blood and lymph sys disorders - Oth Spec
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
3
num At Risk
346
num Events
13
group Id
EG001
num Affected
1
num At Risk
334
num Events
1
term
Eosinophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
346
num Events
1
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
346
num Events
1
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
3
num At Risk
346
num Events
6
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
2
num At Risk
346
num Events
2
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
2
num At Risk
346
num Events
19
group Id
EG001
num Affected
2
num At Risk
334
num Events
4
term
Cardiac disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
4
num At Risk
346
num Events
5
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Chest pain - cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
346
num Events
1
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
3
num At Risk
346
num Events
14
group Id
EG001
num Affected
2
num At Risk
334
num Events
3
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
346
num Events
1
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Sick sinus syndrome

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
346
num Events
2
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Blood and lymph sys disorders - Oth Spec
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
3
num At Risk
346
num Events
3
group Id
EG001
num Affected
5
num At Risk
334
num Events
5
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
4
num At Risk
346
num Events
6
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
5
num At Risk
346
num Events
5
group Id
EG001
num Affected
2
num At Risk
334
num Events
2
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
346
num Events
1
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
1
num At Risk
346
num Events
1
group Id
EG001
num Affected
2
num At Risk
334
num Events
2
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
346
num Events
0
group Id
EG001
num Affected
1
num At Risk
334
num Events
1
term
Cardiac disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
8
num At Risk
346
num Events
8
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Chest pain - cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
4
num At Risk
346
num Events
4
group Id
EG001
num Affected
1
num At Risk
334
num Events
1
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
3
num At Risk
346
num Events
3
group Id
EG001
num Affected
2
num At Risk
334
num Events
2
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
0
num At Risk
346
num Events
0
group Id
EG001
num Affected
1
num At Risk
334
num Events
1
term
Restrictive cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.1
stats
group Id
EG000
num Affected
2
num At Risk
346
num Events
2
group Id
EG001
num Affected
0
num At Risk
334
num Events
0
term
Sinus tachycardia

time Frame

5 years

Download exact source JSON → · Snapshot ctgov-results-aad7e863b8b06225cd4e94e7

Preserved source evidence · Not medical advice