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NCT02314169 · OUTCOME

Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)

Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer · Source last updated 2026-07-31

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment

What was measured

Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The highest grade that occurred for a participant was recorded per toxicity.

Analysis population: This analysis includes only those patients who received at least one dose of study drug.

Groups in this outcome

Part A: Nivolumab

This primary outcome measure is assessed from patients enrolled onto Part A of this study.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part A: Nivolumab37

Reported measurements

Anaemia

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab13Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab11Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab2Not reportedNot reportedNot reportedNot reported

Did not experience this adverse event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab11Not reportedNot reportedNot reportedNot reported
Fatigue

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab17Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab7Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab1Not reportedNot reportedNot reportedNot reported

Did not experience this adverse event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab12Not reportedNot reportedNot reportedNot reported
Rash

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab8Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab2Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab1Not reportedNot reportedNot reportedNot reported

Did not experience this adverse event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab26Not reportedNot reportedNot reportedNot reported
Constipation

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab8Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab2Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab0Not reportedNot reportedNot reportedNot reported

Did not experience this adverse event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab27Not reportedNot reportedNot reportedNot reported
Anorexia

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab5Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab4Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab0Not reportedNot reportedNot reportedNot reported

Did not experience this adverse event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab28Not reportedNot reportedNot reportedNot reported
Diarrhea

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab8Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab0Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab0Not reportedNot reportedNot reportedNot reported

Did not experience this adverse event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab29Not reportedNot reportedNot reportedNot reported
Weight loss

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab5Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab1Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab0Not reportedNot reportedNot reportedNot reported

Did not experience this adverse event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab31Not reportedNot reportedNot reportedNot reported
Arthralgia

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab3Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab3Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab0Not reportedNot reportedNot reportedNot reported

Did not experience this adverse event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab31Not reportedNot reportedNot reportedNot reported
Hyperglycaemia

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab3Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab1Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab0Not reportedNot reportedNot reportedNot reported

Did not experience this adverse event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab33Not reportedNot reportedNot reportedNot reported
Hypothyroidism

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab1Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab1Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab1Not reportedNot reportedNot reportedNot reported

Did not experience this adverse event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab34Not reportedNot reportedNot reportedNot reported
Lymphoedema

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab1Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab1Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab0Not reportedNot reportedNot reportedNot reported

Did not experience this adverse event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab35Not reportedNot reportedNot reportedNot reported
Nausea

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab2Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab0Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab0Not reportedNot reportedNot reportedNot reported

Did not experience this adverse event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab35Not reportedNot reportedNot reportedNot reported
Pneumonitis

Grade 1

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab0Not reportedNot reportedNot reportedNot reported

Grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab1Not reportedNot reportedNot reportedNot reported

Grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab0Not reportedNot reportedNot reportedNot reported

Did not experience this adverse event

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: Nivolumab36Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      title
      Grade 1
    2. measurements
      1. group Id
        OG000
        value
        11
      title
      Grade 2
    3. measurements
      1. group Id
        OG000
        value
        2
      title
      Grade 3
    4. measurements
      1. group Id
        OG000
        value
        11
      title
      Did not experience this adverse event
    title
    Anaemia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      title
      Grade 1
    2. measurements
      1. group Id
        OG000
        value
        7
      title
      Grade 2
    3. measurements
      1. group Id
        OG000
        value
        1
      title
      Grade 3
    4. measurements
      1. group Id
        OG000
        value
        12
      title
      Did not experience this adverse event
    title
    Fatigue
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      title
      Grade 1
    2. measurements
      1. group Id
        OG000
        value
        2
      title
      Grade 2
    3. measurements
      1. group Id
        OG000
        value
        1
      title
      Grade 3
    4. measurements
      1. group Id
        OG000
        value
        26
      title
      Did not experience this adverse event
    title
    Rash
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      title
      Grade 1
    2. measurements
      1. group Id
        OG000
        value
        2
      title
      Grade 2
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 3
    4. measurements
      1. group Id
        OG000
        value
        27
      title
      Did not experience this adverse event
    title
    Constipation
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      title
      Grade 1
    2. measurements
      1. group Id
        OG000
        value
        4
      title
      Grade 2
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 3
    4. measurements
      1. group Id
        OG000
        value
        28
      title
      Did not experience this adverse event
    title
    Anorexia
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      title
      Grade 1
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 2
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 3
    4. measurements
      1. group Id
        OG000
        value
        29
      title
      Did not experience this adverse event
    title
    Diarrhea
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      title
      Grade 1
    2. measurements
      1. group Id
        OG000
        value
        1
      title
      Grade 2
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 3
    4. measurements
      1. group Id
        OG000
        value
        31
      title
      Did not experience this adverse event
    title
    Weight loss
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      title
      Grade 1
    2. measurements
      1. group Id
        OG000
        value
        3
      title
      Grade 2
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 3
    4. measurements
      1. group Id
        OG000
        value
        31
      title
      Did not experience this adverse event
    title
    Arthralgia
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      title
      Grade 1
    2. measurements
      1. group Id
        OG000
        value
        1
      title
      Grade 2
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 3
    4. measurements
      1. group Id
        OG000
        value
        33
      title
      Did not experience this adverse event
    title
    Hyperglycaemia
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      title
      Grade 1
    2. measurements
      1. group Id
        OG000
        value
        1
      title
      Grade 2
    3. measurements
      1. group Id
        OG000
        value
        1
      title
      Grade 3
    4. measurements
      1. group Id
        OG000
        value
        34
      title
      Did not experience this adverse event
    title
    Hypothyroidism
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      title
      Grade 1
    2. measurements
      1. group Id
        OG000
        value
        1
      title
      Grade 2
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 3
    4. measurements
      1. group Id
        OG000
        value
        35
      title
      Did not experience this adverse event
    title
    Lymphoedema
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      title
      Grade 1
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 2
    3. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade 3
    4. measurements
      1. group Id
        OG000
        value
        35
      title
      Did not experience this adverse event
    title
    Nausea
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    units
    Participants
description
Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The highest grade that occurred for a participant was recorded per toxicity.
groups
  1. description
    This primary outcome measure is assessed from patients enrolled onto Part A of this study.
    id
    OG000
    title
    Part A: Nivolumab
param Type
COUNT_OF_PARTICIPANTS
population Description
This analysis includes only those patients who received at least one dose of study drug.
reporting Status
POSTED
time Frame
Adverse event data were collected during treatment (up to 100 months) and through 100 days post treatment
title
Treatment-related Toxicities That Occurred in at Least 1 Patient (Part A)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice