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NCT00354835 · OUTCOME

Acute and Late Effects of VAC as Delivered on This Study to D9803 VAC

Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma · Source last updated 2023-01-31

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
Up to 43 weeks

What was measured

The toxicity rates will be estimated for each phase and course of treatment, and will be compared to the fixed rates under D9803 using one-sided lower confidence intervals for a single proportion without adjustment for multiple comparisons.

Analysis population: Number of patients with specific adverse events.

Groups in this outcome

VAC (Weeks 1-15)

Reporting period 1 (acute)

VAC (Weeks 31 - 43)

Reporting period 3 (late)

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

Analysis denominator · Participants

GroupSource count
VAC (Weeks 1-15)222
VAC (Weeks 31 - 43)193

Reported measurements

Anemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
VAC (Weeks 1-15)58Not reportedNot reportedNot reportedNot reported
VAC (Weeks 31 - 43)54Not reportedNot reportedNot reportedNot reported
Febrile Neutropenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
VAC (Weeks 1-15)30Not reportedNot reportedNot reportedNot reported
VAC (Weeks 31 - 43)17Not reportedNot reportedNot reportedNot reported
Nausea or Hepatopathy
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
VAC (Weeks 1-15)6Not reportedNot reportedNot reportedNot reported
VAC (Weeks 31 - 43)1Not reportedNot reportedNot reportedNot reported
Platelet Count Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
VAC (Weeks 1-15)27Not reportedNot reportedNot reportedNot reported
VAC (Weeks 31 - 43)63Not reportedNot reportedNot reportedNot reported
Vomiting
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
VAC (Weeks 1-15)9Not reportedNot reportedNot reportedNot reported
VAC (Weeks 31 - 43)2Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Num Sides
    ONE_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.31
    group Description
    Compare incidence of Anemia to historical rate of 0.40 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. Comparing the incidence of anemia with VAC on ARST0531 to the historical rate of 0.40 with VAC on D9803. The 95% one-sided confidence interval for the incidence of anemia will be calculated and evaluated to see if the interval contains the null rate of 0.40.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    The incidence of anemia
    param Value
    0.2613
  2. ci Num Sides
    ONE_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.0449
    group Description
    Compare incidence of Nausea or Hepatopathy to historical rate of 0.05 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of nausea or hepatopathy will be calculated and evaluated to see if the interval contains the null rate of 0.05.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    The incidence of nausea or hepatopathy
    param Value
    0.0270
  3. ci Num Sides
    ONE_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.1729
    group Description
    Compare incidence of Febrile Neutropenia to historical rate of 0.50 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of febrile neutropenia will be calculated and evaluated to see if the interval contains the null rate of 0.50.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    The incidence of febrile neutropenia
    param Value
    0.1351
  4. ci Num Sides
    ONE_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.1577
    group Description
    Compare incidence of Platelet Count Decreased to historical rate of 0.70 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of platelet count decreased will be calculated and evaluated to see if the interval contains the null rate of 0.70.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    The incidence of platelet count decrease
    param Value
    0.1216
  5. ci Num Sides
    ONE_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.0623
    group Description
    Compare incidence of Vomiting to historical rate of 0.15 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of vomiting will be calculated and evaluated to see if the interval contains the null rate of 0.15.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    The incidence of vomiting
    param Value
    0.0405
  6. ci Num Sides
    ONE_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.3329
    group Description
    Compare incidence of Anemia to historical rate of 0.40 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. 95% one-sided confidence interval for the incidence of anemia will be calculated and evaluated to see if the interval contains the null rate of 0.40.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    The incidence of anemia
    param Value
    0.2798
  7. ci Num Sides
    ONE_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.0137
    group Description
    Compare incidence of Nausea or Hepatopathy to historical rate of 0.05 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of nausea or hepatopathy will be calculated and evaluated to see if the interval contains the null rate of 0.05.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    The incidence of nausea or hepatopathy
    param Value
    0.0052
  8. ci Num Sides
    ONE_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.1216
    group Description
    Compare incidence of Febrile Neutropenia to historical rate of 0.50 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of febrile neutropenia will be calculated and evaluated to see if the interval contains the null rate of 0.50.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    The incidence of febrile neutropenia
    param Value
    0.0881
  9. ci Num Sides
    ONE_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.3819
    group Description
    Compare incidence of Platelet Count Decreased to historical rate of 0.70 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of platelet count decreased will be calculated and evaluated to see if the interval contains the null rate of 0.70.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    The incidence of platelet count decrease
    param Value
    0.3264
  10. ci Num Sides
    ONE_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.0224
    group Description
    Compare incidence of Vomiting to historical rate of 0.15 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of vomiting will be calculated and evaluated to see if the interval contains the null rate of 0.15.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    The incidence of vomiting
    param Value
    0.0104
Complete source fields
analyses
  1. ci Num Sides
    ONE_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.31
    group Description
    Compare incidence of Anemia to historical rate of 0.40 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. Comparing the incidence of anemia with VAC on ARST0531 to the historical rate of 0.40 with VAC on D9803. The 95% one-sided confidence interval for the incidence of anemia will be calculated and evaluated to see if the interval contains the null rate of 0.40.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    The incidence of anemia
    param Value
    0.2613
  2. ci Num Sides
    ONE_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.0449
    group Description
    Compare incidence of Nausea or Hepatopathy to historical rate of 0.05 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of nausea or hepatopathy will be calculated and evaluated to see if the interval contains the null rate of 0.05.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    The incidence of nausea or hepatopathy
    param Value
    0.0270
  3. ci Num Sides
    ONE_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.1729
    group Description
    Compare incidence of Febrile Neutropenia to historical rate of 0.50 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of febrile neutropenia will be calculated and evaluated to see if the interval contains the null rate of 0.50.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    The incidence of febrile neutropenia
    param Value
    0.1351
  4. ci Num Sides
    ONE_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.1577
    group Description
    Compare incidence of Platelet Count Decreased to historical rate of 0.70 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of platelet count decreased will be calculated and evaluated to see if the interval contains the null rate of 0.70.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    The incidence of platelet count decrease
    param Value
    0.1216
  5. ci Num Sides
    ONE_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.0623
    group Description
    Compare incidence of Vomiting to historical rate of 0.15 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of vomiting will be calculated and evaluated to see if the interval contains the null rate of 0.15.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    The incidence of vomiting
    param Value
    0.0405
  6. ci Num Sides
    ONE_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.3329
    group Description
    Compare incidence of Anemia to historical rate of 0.40 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. 95% one-sided confidence interval for the incidence of anemia will be calculated and evaluated to see if the interval contains the null rate of 0.40.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    The incidence of anemia
    param Value
    0.2798
  7. ci Num Sides
    ONE_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.0137
    group Description
    Compare incidence of Nausea or Hepatopathy to historical rate of 0.05 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of nausea or hepatopathy will be calculated and evaluated to see if the interval contains the null rate of 0.05.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    The incidence of nausea or hepatopathy
    param Value
    0.0052
  8. ci Num Sides
    ONE_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.1216
    group Description
    Compare incidence of Febrile Neutropenia to historical rate of 0.50 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of febrile neutropenia will be calculated and evaluated to see if the interval contains the null rate of 0.50.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    The incidence of febrile neutropenia
    param Value
    0.0881
  9. ci Num Sides
    ONE_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.3819
    group Description
    Compare incidence of Platelet Count Decreased to historical rate of 0.70 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of platelet count decreased will be calculated and evaluated to see if the interval contains the null rate of 0.70.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    The incidence of platelet count decrease
    param Value
    0.3264
  10. ci Num Sides
    ONE_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.0224
    group Description
    Compare incidence of Vomiting to historical rate of 0.15 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of vomiting will be calculated and evaluated to see if the interval contains the null rate of 0.15.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    The incidence of vomiting
    param Value
    0.0104
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        58
      2. group Id
        OG001
        value
        54
    title
    Anemia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        30
      2. group Id
        OG001
        value
        17
    title
    Febrile Neutropenia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        1
    title
    Nausea or Hepatopathy
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        63
    title
    Platelet Count Decreased
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        2
    title
    Vomiting
denoms
  1. counts
    1. group Id
      OG000
      value
      222
    2. group Id
      OG001
      value
      193
    units
    Participants
description
The toxicity rates will be estimated for each phase and course of treatment, and will be compared to the fixed rates under D9803 using one-sided lower confidence intervals for a single proportion without adjustment for multiple comparisons.
groups
  1. description
    Reporting period 1 (acute)
    id
    OG000
    title
    VAC (Weeks 1-15)
  2. description
    Reporting period 3 (late)
    id
    OG001
    title
    VAC (Weeks 31 - 43)
param Type
NUMBER
population Description
Number of patients with specific adverse events.
reporting Status
POSTED
time Frame
Up to 43 weeks
title
Acute and Late Effects of VAC as Delivered on This Study to D9803 VAC
type
SECONDARY
unit Of Measure
participants

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