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NCT01140347 · OUTCOME

Number of Participants With Adverse Events (AEs) and the Number of Participants Who Died

A Study of Ramucirumab (IMC-1121B) Drug Product (DP) and Best Supportive Care (BSC) Versus Placebo and BSC as 2nd-Line Treatment in Participants With Hepatocellular Carcinoma After 1st-Line Therapy With Sorafenib · Source last updated 2015-12-28

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
Baseline to study completion (up to 37 months)

What was measured

The number of participants with serious AEs (SAEs), other non-serious AEs and participants who died. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

Analysis population: Participants who received at least 1 dose of study drug.

Groups in this outcome

Ramucirumab (IMC-1121B) + BSC

Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.

Placebo + BSC

Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.

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

Analysis denominator · Participants

GroupSource count
Ramucirumab (IMC-1121B) + BSC277
Placebo + BSC276

Reported measurements

SAEs
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ramucirumab (IMC-1121B) + BSC123Not reportedNot reportedNot reportedNot reported
Placebo + BSC92Not reportedNot reportedNot reportedNot reported
Other Non-SAEs
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ramucirumab (IMC-1121B) + BSC254Not reportedNot reportedNot reportedNot reported
Placebo + BSC235Not reportedNot reportedNot reportedNot reported
Died
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ramucirumab (IMC-1121B) + BSC215Not reportedNot reportedNot reportedNot reported
Placebo + BSC220Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        123
      2. group Id
        OG001
        value
        92
    title
    SAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        254
      2. group Id
        OG001
        value
        235
    title
    Other Non-SAEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        215
      2. group Id
        OG001
        value
        220
    title
    Died
denoms
  1. counts
    1. group Id
      OG000
      value
      277
    2. group Id
      OG001
      value
      276
    units
    Participants
description
The number of participants with serious AEs (SAEs), other non-serious AEs and participants who died. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
groups
  1. description
    Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
    id
    OG000
    title
    Ramucirumab (IMC-1121B) + BSC
  2. description
    Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
    id
    OG001
    title
    Placebo + BSC
param Type
NUMBER
population Description
Participants who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
Baseline to study completion (up to 37 months)
title
Number of Participants With Adverse Events (AEs) and the Number of Participants Who Died
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice