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NCT00753415 · OUTCOME

Number of Participants With Adverse Events (AEs)

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

This analysis includes the number of participants with AEs and serious AEs (SAEs) during the Treatment Period plus the Acute Follow-up (FU) Period (up to 30 days following last vaccination). An AE was defined as any unfavorable or unintended change in the structure, function or chemistry of the body temporally associated with the use of the product, whether or not considered related to the product, including any worsening of a preexisting condition which was temporally associated with the product. An SAE was defined as an AE resulting in death, was life-threatening, resulted in or prolonged hospitalization, was a congenital anomaly, a cancer, an overdose or other important medical event.

Analysis population: All Participants as Treated (APaT) population; all participants who received at least one vaccination.

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 LD3Not reportedNot reportedNot reportedNot reported
Part A: V934 LD(3)+V935 LD3Not reportedNot reportedNot reportedNot reported
Part A: V935 HD8Not reportedNot reportedNot reportedNot reported
Part A: V934 HD(3)+V935 HD11Not reportedNot reportedNot reportedNot reported
Part A: V934 HD(5)+V935 HD10Not reportedNot reportedNot reportedNot reported
Part B: V935 LD/V934 Booster1Not reportedNot reportedNot reportedNot reported
Part B: V934 LD(3)+V935 LD/V934 Booster1Not reportedNot reportedNot reportedNot reported
Part B: V935 HD/V934 Booster3Not reportedNot reportedNot reportedNot reported
Part B: V934 HD(3)+V935 HD/V934 Booster8Not reportedNot reportedNot reportedNot reported
Part B: V934 HD(5)+V935 HD/V934 Booster7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        11
      5. group Id
        OG004
        value
        10
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        3
      9. group Id
        OG008
        value
        8
      10. group Id
        OG009
        value
        7
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
This analysis includes the number of participants with AEs and serious AEs (SAEs) during the Treatment Period plus the Acute Follow-up (FU) Period (up to 30 days following last vaccination). An AE was defined as any unfavorable or unintended change in the structure, function or chemistry of the body temporally associated with the use of the product, whether or not considered related to the product, including any worsening of a preexisting condition which was temporally associated with the product. An SAE was defined as an AE resulting in death, was life-threatening, resulted in or prolonged hospitalization, was a congenital anomaly, a cancer, an overdose or other important medical event.
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
All Participants as Treated (APaT) population; all participants who received at least one vaccination.
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 Adverse Events (AEs)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice