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NCT03146650 · OUTCOME

Number of Adverse Events Possibly Related to Study Drugs Graded 3, 4, and 5

Nivolumab and Ipilimumab in Treating Patients With Metastatic/Recurrent ACC of All Sites and Non-ACC Salivary Gland Cancer · Source last updated 2024-01-18

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
Up to 30 days after discontinuation, where range of cycles attempted was 1-11, where 1 Cycle = 84 days/12 weeks

What was measured

Toxicity, both frequency and severity, will continue to be measured by monitoring the occurrence of adverse events. Adverse events will be defined as those included in CTCAE v 4.03. AEs that were determined to be at least possibly related to study drug and graded 3, 4, 5 are included here. Grade 1 (mild): the event causes discomfort without disruption of normal daily activities. Grade 2 (moderate): the event causes discomfort that affects normal daily activities. Grade 3 (severe): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status. Grade 4 (Life-threatening): the patient was at risk of death at the time of the event. Grade 5 (fatal): the event caused death.

Groups in this outcome

Nivolumab + Ipilimumab

Nivolumab and ipilimumab combination will be administered intravenously until disease progression or intolerable toxicity. Nivolumab: Given at 240mg over 30 minutes (-5 / +15 minutes) every 2 weeks starting with Cycle 1 Day 1 for the first 16 weeks (1 cycle = 12 weeks). Starting with Cycle 2 Day 29, nivolumab will be given at 480mg IV over 60 minutes (-10 / +15 minutes) every 4 weeks. Ipilimumab: Given at 1mg/Kg every 6 weeks starting with Cycle 1 Day 1 over approximately 90 minutes (-5 / +15 minutes). On days when both nivolumab and ipilimumab are administered, nivolumab should be given first, followed by ipilimumab about 30 minutes after completion of nivolumab. Patients will be assessed for response every 12 weeks (±7 days).

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

Analysis denominator · Participants

GroupSource count
Nivolumab + Ipilimumab24

Reported measurements

Fatigue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ipilimumab1Not reportedNot reportedNot reportedNot reported
Lymphocyte Count Decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ipilimumab4Not reportedNot reportedNot reportedNot reported
Anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ipilimumab2Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ipilimumab1Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ipilimumab1Not reportedNot reportedNot reportedNot reported
Anorexia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ipilimumab1Not reportedNot reportedNot reportedNot reported
Alanine Aminotransferase Increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ipilimumab1Not reportedNot reportedNot reportedNot reported
Weight Loss
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ipilimumab1Not reportedNot reportedNot reportedNot reported
Adrenal Insufficiency
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ipilimumab1Not reportedNot reportedNot reportedNot reported
Rash maculo-papular
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ipilimumab1Not reportedNot reportedNot reportedNot reported
Alkaline Phosphatase Increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ipilimumab1Not reportedNot reportedNot reportedNot reported
Colitis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ipilimumab1Not reportedNot reportedNot reportedNot reported
Mucositis oral
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ipilimumab1Not reportedNot reportedNot reportedNot reported
Hypokalemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ipilimumab1Not reportedNot reportedNot reportedNot reported
Hypophosphatemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ipilimumab1Not reportedNot reportedNot reportedNot reported
Serum Amylase Increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ipilimumab1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Fatigue
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Lymphocyte Count Decreased
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Anemia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Aspartate Aminotransferase increased
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Diarrhea
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Anorexia
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Alanine Aminotransferase Increased
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Weight Loss
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Adrenal Insufficiency
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Rash maculo-papular
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Alkaline Phosphatase Increased
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Colitis
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    units
    Participants
description
Toxicity, both frequency and severity, will continue to be measured by monitoring the occurrence of adverse events. Adverse events will be defined as those included in CTCAE v 4.03. AEs that were determined to be at least possibly related to study drug and graded 3, 4, 5 are included here. Grade 1 (mild): the event causes discomfort without disruption of normal daily activities. Grade 2 (moderate): the event causes discomfort that affects normal daily activities. Grade 3 (severe): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status. Grade 4 (Life-threatening): the patient was at risk of death at the time of the event. Grade 5 (fatal): the event caused death.
groups
  1. description
    Nivolumab and ipilimumab combination will be administered intravenously until disease progression or intolerable toxicity. Nivolumab: Given at 240mg over 30 minutes (-5 / +15 minutes) every 2 weeks starting with Cycle 1 Day 1 for the first 16 weeks (1 cycle = 12 weeks). Starting with Cycle 2 Day 29, nivolumab will be given at 480mg IV over 60 minutes (-10 / +15 minutes) every 4 weeks. Ipilimumab: Given at 1mg/Kg every 6 weeks starting with Cycle 1 Day 1 over approximately 90 minutes (-5 / +15 minutes). On days when both nivolumab and ipilimumab are administered, nivolumab should be given first, followed by ipilimumab about 30 minutes after completion of nivolumab. Patients will be assessed for response every 12 weeks (±7 days).
    id
    OG000
    title
    Nivolumab + Ipilimumab
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 30 days after discontinuation, where range of cycles attempted was 1-11, where 1 Cycle = 84 days/12 weeks
title
Number of Adverse Events Possibly Related to Study Drugs Graded 3, 4, and 5
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice