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NCT00337129 · OUTCOME

Response Probability (Confirmed Complete and Partial Responses)

S0618 E7389 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer · Source last updated 2015-08-25

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
Every 6 weeks until progression of disease up to a maximum of 3 years after registration

What was measured

Response was defined per RECIST. Complete response (CR) was defined as complete disappearance of all baseline measurable and non-measurable disease with no new lesions. Partial response (PR) was defined as at least 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. A CR or PR must be confirmed by a second determination at least 4 weeks apart. All disease must have been assessed using the same technique as baseline.

Analysis population: Only eligible patients were included in the analysis

Groups in this outcome

Treatment (E7389 IV)

Patients receive E7389 IV on days 1 and 8 of an every 21-day 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
Treatment (E7389 IV)40

Reported measurements

Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (E7389 IV)0Not reportedNot reportedNot reportedNot reported
Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (E7389 IV)2Not reportedNot reportedNot reportedNot reported
No Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (E7389 IV)38Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.01
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.17
    group Description
    Null hypothesis: response probability \< 5%; alternative hypothesis: response probability \> 20%. A two-stage design was used. If no responses among the first 20 patients, the study would be terminated with the conclusion that E7389 is inactive. However, if at least one response was seen then an additional 20 patients would be accrued. Five or more responses out of 40 would be considered evidence that E7389 warranted further study. This design had a significance level of 5% and a power of 92%.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Response probability
    param Value
    0.05
    statistical Method
    two-stage binomial
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.01
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.17
    group Description
    Null hypothesis: response probability \< 5%; alternative hypothesis: response probability \> 20%. A two-stage design was used. If no responses among the first 20 patients, the study would be terminated with the conclusion that E7389 is inactive. However, if at least one response was seen then an additional 20 patients would be accrued. Five or more responses out of 40 would be considered evidence that E7389 warranted further study. This design had a significance level of 5% and a power of 92%.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Response probability
    param Value
    0.05
    statistical Method
    two-stage binomial
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        38
    title
    No Response
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    units
    Participants
description
Response was defined per RECIST. Complete response (CR) was defined as complete disappearance of all baseline measurable and non-measurable disease with no new lesions. Partial response (PR) was defined as at least 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. A CR or PR must be confirmed by a second determination at least 4 weeks apart. All disease must have been assessed using the same technique as baseline.
groups
  1. description
    Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
    id
    OG000
    title
    Treatment (E7389 IV)
param Type
NUMBER
population Description
Only eligible patients were included in the analysis
reporting Status
POSTED
time Frame
Every 6 weeks until progression of disease up to a maximum of 3 years after registration
title
Response Probability (Confirmed Complete and Partial Responses)
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice