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NCT00720941 · OUTCOME

Number of Participants With Adverse Events

Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma · Source last updated 2025-03-30

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
From study treatment start date till 28 days safety follow-up, assessed up to approximately 152 months

What was measured

The distribution of adverse events was done via the analysis of frequencies for Adverse Event (AEs) and Serious Adverse Event (SAEs), through the monitoring of relevant clinical and laboratory safety parameters.

Analysis population: Safety Population: all randomized participants who received at least one dose of study medication, according to the actual treatment received.

Groups in this outcome

Pazopanib 800 mg

Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

Sunitinib 50 mg

Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.

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

Analysis denominator · Participants

GroupSource count
Pazopanib 800 mg554
Sunitinib 50 mg548

Reported measurements

Adverse Events (AEs)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg551Not reportedNot reportedNot reportedNot reported
Sunitinib 50 mg535Not reportedNot reportedNot reportedNot reported
Serious Adverse Events (SAEs)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pazopanib 800 mg242Not reportedNot reportedNot reportedNot reported
Sunitinib 50 mg227Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        551
      2. group Id
        OG001
        value
        535
    title
    Adverse Events (AEs)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        242
      2. group Id
        OG001
        value
        227
    title
    Serious Adverse Events (SAEs)
denoms
  1. counts
    1. group Id
      OG000
      value
      554
    2. group Id
      OG001
      value
      548
    units
    Participants
description
The distribution of adverse events was done via the analysis of frequencies for Adverse Event (AEs) and Serious Adverse Event (SAEs), through the monitoring of relevant clinical and laboratory safety parameters.
groups
  1. description
    Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
    id
    OG000
    title
    Pazopanib 800 mg
  2. description
    Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
    id
    OG001
    title
    Sunitinib 50 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Population: all randomized participants who received at least one dose of study medication, according to the actual treatment received.
reporting Status
POSTED
time Frame
From study treatment start date till 28 days safety follow-up, assessed up to approximately 152 months
title
Number of Participants With Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice