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NCT03502746 · OUTCOME

Adverse Event Assessment

Phase II Nivolumab and Ramucirumab for Patients With Previously-Treated Mesothelioma · Source last updated 2024-05-14

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
AE had been recorded from time of consent until 100 days after discontinuation of study drug or until a new anti-cancer treatment starts, whichever occurs first; up to a maximum of 28 months.

What was measured

The frequency and severity of all grade ≥ 2 treatment related adverse events are reported by CTCAE v4 term.

Groups in this outcome

Nivolumab + Ramucirumab

Nivolumab 240mg IV + Ramucirumab 8mg/kg IV Nivolumab: Nivolumab 240mg, IV over 30 minutes. Ramucirumab: 8mg/kg, IV over 60 minutes.

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 + Ramucirumab34

Reported measurements

Dyspnea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab5Not reportedNot reportedNot reportedNot reported
Hypertension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab3Not reportedNot reportedNot reportedNot reported
Proteinuria
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab9Not reportedNot reportedNot reportedNot reported
Arial fibrillation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab2Not reportedNot reportedNot reportedNot reported
Abdominal Pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Anorexia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab2Not reportedNot reportedNot reportedNot reported
Dehydration
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Dysphagia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Esophageal Obstruction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Fatigue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab7Not reportedNot reportedNot reportedNot reported
Hyperkalemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Hyponatremia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Muscle Weakness
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab3Not reportedNot reportedNot reportedNot reported
Non-Cardiac Chest Pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Pancreatitis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Thromboembolic Event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab3Not reportedNot reportedNot reportedNot reported
Sinusitis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab3Not reportedNot reportedNot reportedNot reported
Depression
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab2Not reportedNot reportedNot reportedNot reported
Hypothyroidism
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab2Not reportedNot reportedNot reportedNot reported
Dizziness
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab2Not reportedNot reportedNot reportedNot reported
Chest Wall Pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Cough
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Creatinine Increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Heart Failure
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Hypoxia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Lower Gastrointestinal Bleed
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Mucositis Oral
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Periodontal Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Pneumonitis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Presyncope
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Weight loss
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Atopic Dermatitis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Upper Respiratory Tract Infection
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Ramucirumab1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Dyspnea
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Hypertension
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Proteinuria
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Arial fibrillation
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Abdominal Pain
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Anorexia
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Dehydration
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Diarrhea
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Dysphagia
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Esophageal Obstruction
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Fatigue
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hyperkalemia
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    units
    Participants
description
The frequency and severity of all grade ≥ 2 treatment related adverse events are reported by CTCAE v4 term.
groups
  1. description
    Nivolumab 240mg IV + Ramucirumab 8mg/kg IV Nivolumab: Nivolumab 240mg, IV over 30 minutes. Ramucirumab: 8mg/kg, IV over 60 minutes.
    id
    OG000
    title
    Nivolumab + Ramucirumab
param Type
NUMBER
reporting Status
POSTED
time Frame
AE had been recorded from time of consent until 100 days after discontinuation of study drug or until a new anti-cancer treatment starts, whichever occurs first; up to a maximum of 28 months.
title
Adverse Event Assessment
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice