Skip to content
← Full study record

NCT02564198 · OUTCOME

Overall Survival

A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors · Source last updated 2021-08-17

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Baseline to Date of Death from Any Cause (Up to 42 Months)

What was measured

Overall survival is defined as the time from date of randomization to the date of death (due to any cause). For participants whose last known status is alive at the data cutoff date for the analysis, time will be censored as the last contact date prior to the data cutoff date.

Analysis population: All randomized participants who received at least one dose of study drug.

Groups in this outcome

8 mg/kg Ramucirumab (Part A)

Participants received 8 mg/kg Ramucirumab administered as an intravenous infusion Q2W with 3 doses per 42 day cycle.

12 mg/kg Ramucirumab (Part A)

Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.

12 mg/kg Ramucirumab (Part B)

Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.

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

Analysis denominator · Participants

GroupSource count
8 mg/kg Ramucirumab (Part A)8
12 mg/kg Ramucirumab (Part A)15
12 mg/kg Ramucirumab (Part B)6

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
8 mg/kg Ramucirumab (Part A)NANot reportedNANAThere were not enough events/deaths to compute a median or 95% confidence interval.
12 mg/kg Ramucirumab (Part A)NANot reportedNANAThere were not enough events/deaths to compute a median or 95% confidence interval.
12 mg/kg Ramucirumab (Part B)NANot reportedNANAThere were not enough events/deaths to compute a median or 95% confidence interval.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        There were not enough events/deaths to compute a median or 95% confidence interval.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        There were not enough events/deaths to compute a median or 95% confidence interval.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        There were not enough events/deaths to compute a median or 95% confidence interval.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      15
    3. group Id
      OG002
      value
      6
    units
    Participants
description
Overall survival is defined as the time from date of randomization to the date of death (due to any cause). For participants whose last known status is alive at the data cutoff date for the analysis, time will be censored as the last contact date prior to the data cutoff date.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 8 mg/kg Ramucirumab administered as an intravenous infusion Q2W with 3 doses per 42 day cycle.
    id
    OG000
    title
    8 mg/kg Ramucirumab (Part A)
  2. description
    Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
    id
    OG001
    title
    12 mg/kg Ramucirumab (Part A)
  3. description
    Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
    id
    OG002
    title
    12 mg/kg Ramucirumab (Part B)
param Type
MEDIAN
population Description
All randomized participants who received at least one dose of study drug.
reporting Status
POSTED
time Frame
Baseline to Date of Death from Any Cause (Up to 42 Months)
title
Overall Survival
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice