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NCT00753415 · OUTCOME

Number of Participants With Dose-Limiting Toxicity (DLT)

A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002) · Source last updated 2015-03-17

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
Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period

What was measured

DLT was defined as a vaccine- or EP-related adverse event (AE) including the following: Hematological (Grade 3 neutropenia with fever, Grade 4 neutropenia ≥5 days, Grade 4 thrombocytopenia) or non-hematological AE, Grade 3, 4 or 5 with the exception of Grade 3 nausea, vomiting, diarrhea or serum glutamic oxaloacetic transaminase (SGOT) elevation, alopecia, Grade 3/4 creatinine phosphokinase (CPK) elevation or inadequately treated hypersensitivity. Any Grade 3/4 related AE that failed to return to ≤Grade 1 or baseline within 14 days was also considered a DLT.

Analysis population: Evaluable patients who completed all scheduled vaccinations were included in the DLT analysis.

Groups in this outcome

Part A: V935 LD

Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.

Part A: V934 LD(3)+V935 LD

Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.

Part A: V935 HD

Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.

Part A: V934 HD(3)+V935 HD

Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.

Part A: V934 HD(5)+V935 HD

Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.

Part B: V935 LD/V934 Booster

Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.

Part B: V934 LD(3)+V935 LD/V934 Booster

Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.

Part B: V935 HD/V934 Booster

Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.

Part B: V934 HD(3)+V935 HD/V934 Booster

Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.

Part B: V934 HD(5)+V935 HD/V934 Booster

Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.

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

Analysis denominator · Participants

GroupSource count
Part A: V935 LD3
Part A: V934 LD(3)+V935 LD3
Part A: V935 HD10
Part A: V934 HD(3)+V935 HD11
Part A: V934 HD(5)+V935 HD10
Part B: V935 LD/V934 Booster1
Part B: V934 LD(3)+V935 LD/V934 Booster2
Part B: V935 HD/V934 Booster7
Part B: V934 HD(3)+V935 HD/V934 Booster9
Part B: V934 HD(5)+V935 HD/V934 Booster9

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: V935 LD0Not reportedNot reportedNot reportedNot reported
Part A: V934 LD(3)+V935 LD0Not reportedNot reportedNot reportedNot reported
Part A: V935 HD0Not reportedNot reportedNot reportedNot reported
Part A: V934 HD(3)+V935 HD0Not reportedNot reportedNot reportedNot reported
Part A: V934 HD(5)+V935 HD0Not reportedNot reportedNot reportedNot reported
Part B: V935 LD/V934 Booster0Not reportedNot reportedNot reportedNot reported
Part B: V934 LD(3)+V935 LD/V934 Booster0Not reportedNot reportedNot reportedNot reported
Part B: V935 HD/V934 Booster0Not reportedNot reportedNot reportedNot reported
Part B: V934 HD(3)+V935 HD/V934 Booster0Not reportedNot reportedNot reportedNot reported
Part B: V934 HD(5)+V935 HD/V934 Booster0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      11
    5. group Id
      OG004
      value
      10
    6. group Id
      OG005
      value
      1
    7. group Id
      OG006
      value
      2
    8. group Id
      OG007
      value
      7
    9. group Id
      OG008
      value
      9
    10. group Id
      OG009
      value
      9
    units
    Participants
description
DLT was defined as a vaccine- or EP-related adverse event (AE) including the following: Hematological (Grade 3 neutropenia with fever, Grade 4 neutropenia ≥5 days, Grade 4 thrombocytopenia) or non-hematological AE, Grade 3, 4 or 5 with the exception of Grade 3 nausea, vomiting, diarrhea or serum glutamic oxaloacetic transaminase (SGOT) elevation, alopecia, Grade 3/4 creatinine phosphokinase (CPK) elevation or inadequately treated hypersensitivity. Any Grade 3/4 related AE that failed to return to ≤Grade 1 or baseline within 14 days was also considered a DLT.
groups
  1. description
    Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
    id
    OG000
    title
    Part A: V935 LD
  2. description
    Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
    id
    OG001
    title
    Part A: V934 LD(3)+V935 LD
  3. description
    Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
    id
    OG002
    title
    Part A: V935 HD
  4. description
    Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
    id
    OG003
    title
    Part A: V934 HD(3)+V935 HD
  5. description
    Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
    id
    OG004
    title
    Part A: V934 HD(5)+V935 HD
  6. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    id
    OG005
    title
    Part B: V935 LD/V934 Booster
  7. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    id
    OG006
    title
    Part B: V934 LD(3)+V935 LD/V934 Booster
  8. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    id
    OG007
    title
    Part B: V935 HD/V934 Booster
  9. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    id
    OG008
    title
    Part B: V934 HD(3)+V935 HD/V934 Booster
  10. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    id
    OG009
    title
    Part B: V934 HD(5)+V935 HD/V934 Booster
param Type
NUMBER
population Description
Evaluable patients who completed all scheduled vaccinations were included in the DLT analysis.
reporting Status
POSTED
time Frame
Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period
title
Number of Participants With Dose-Limiting Toxicity (DLT)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice