NCT03595124 · ADVERSE EVENTS

Adverse events

A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC) · Source last updated 2026-08-28

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: Up to 5 years after randomization
Other-event reporting threshold: 0%

Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A (Axitinib, Nivolumab) Patients receive axitinib PO BID on days 1-28 and nivolumab intravenously (IV) over 30 minutes, or per institutional guidelines, on days 1 and 15 (if \< 18 years old) or on day 1 (if \>= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.	4 / 6	2 / 6	1 / 6
Arm B (Axitinib) Patients receive axitinib PO BID on days 1-28. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AS OF 1/23/2020 - PROSPECTIVE PATIENTS ARE RANDOMLY ASSIGNED TO ARMS A OR C)	2 / 2	0 / 2	2 / 2
Arm C (Nivolumab) Patients receive nivolumab IV over 30 minutes, or per institutional guidelines, on days 1 and 15 (if \< 18 years old) or on day 1 (if \>= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.	5 / 5	1 / 5	4 / 5

Group identifiers: EG000: Arm A (Axitinib, Nivolumab) · EG001: Arm B (Axitinib) · EG002: Arm C (Nivolumab)

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
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
5
num Events
1
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Chylous ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
3
num At Risk
5
num Events
3
term
Death NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
5
num Events
1
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
2
num At Risk
2
num Events
2
group Id
EG002
num Affected
1
num At Risk
5
num Events
1
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
2
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Eosinophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Hypophosphatemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
5
num Events
1
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
5
num Events
1
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Non-cardiac chest 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
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
2
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
4
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
5
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
2
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
2
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Decreased T4
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
2
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Ejection fraction decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Elevated Platelets
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Eye pain

Complete source fields

description

event Groups

deaths Num Affected
1
deaths Num At Risk
6
description
Patients receive axitinib PO BID on days 1-28 and nivolumab intravenously (IV) over 30 minutes, or per institutional guidelines, on days 1 and 15 (if \< 18 years old) or on day 1 (if \>= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
2
other Num At Risk
6
serious Num Affected
4
serious Num At Risk
6
title
Arm A (Axitinib, Nivolumab)
deaths Num Affected
2
deaths Num At Risk
2
description
Patients receive axitinib PO BID on days 1-28. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL AS OF 1/23/2020 - PROSPECTIVE PATIENTS ARE RANDOMLY ASSIGNED TO ARMS A OR C)
id
EG001
other Num Affected
0
other Num At Risk
2
serious Num Affected
2
serious Num At Risk
2
title
Arm B (Axitinib)
deaths Num Affected
4
deaths Num At Risk
5
description
Patients receive nivolumab IV over 30 minutes, or per institutional guidelines, on days 1 and 15 (if \< 18 years old) or on day 1 (if \>= 18 years old). Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
id
EG002
other Num Affected
1
other Num At Risk
5
serious Num Affected
5
serious Num At Risk
5
title
Arm C (Nivolumab)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
2
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
4
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
5
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
2
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
2
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Decreased T4
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
2
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Ejection fraction decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Elevated Platelets
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Eye pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
5
num Events
1
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Chylous ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
3
num At Risk
5
num Events
3
term
Death NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
5
num Events
1
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
2
num At Risk
2
num Events
2
group Id
EG002
num Affected
1
num At Risk
5
num Events
1
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
2
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Eosinophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Hypophosphatemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
5
num Events
1
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
1
num At Risk
5
num Events
1
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE v5.0
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
2
num Events
0
group Id
EG002
num Affected
0
num At Risk
5
num Events
0
term
Non-cardiac chest pain

time Frame

Up to 5 years after randomization

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice