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NCT02356159 · OUTCOME

Phase I and/or Phase 2: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation · Source last updated 2025-09-30

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
All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years.

What was measured

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Groups in this outcome

Phase I Palifermin Dose Level 1: 180 mcg/kg Intravenous (IV) on Day-7

Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.

Phase I Palifermin Dose Level 2: 360 mcg/kg Intravenous (IV) on Day-7

Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.

Phase I Palifermin Dose Level 3: 540 mcg/kg Intravenous (IV) on Day-7

Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.

Phase I Palifermin Dose Level 4: 720 mcg/kg Intravenous (IV) on Day-7

Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.

Phase 2 Palifermin: 720 mcg/kg Intravenous (IV) Dose

Induction chemotherapy, then palifermin at the recommended phase 2 dose (RP2D) determined in Phase 1, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.

Participants Enrolled But Not Treated on Research Phase (Palifermin + Transplant)

Participants were enrolled but not treated on Research Phase (Palifermin + Transplant).

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

Analysis denominator · Participants

GroupSource count
Phase I Palifermin Dose Level 1: 180 mcg/kg Intravenous (IV) on Day-76
Phase I Palifermin Dose Level 2: 360 mcg/kg Intravenous (IV) on Day-73
Phase I Palifermin Dose Level 3: 540 mcg/kg Intravenous (IV) on Day-73
Phase I Palifermin Dose Level 4: 720 mcg/kg Intravenous (IV) on Day-73
Phase 2 Palifermin: 720 mcg/kg Intravenous (IV) Dose16
Participants Enrolled But Not Treated on Research Phase (Palifermin + Transplant)3

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I Palifermin Dose Level 1: 180 mcg/kg Intravenous (IV) on Day-76Not reportedNot reportedNot reportedNot reported
Phase I Palifermin Dose Level 2: 360 mcg/kg Intravenous (IV) on Day-73Not reportedNot reportedNot reportedNot reported
Phase I Palifermin Dose Level 3: 540 mcg/kg Intravenous (IV) on Day-73Not reportedNot reportedNot reportedNot reported
Phase I Palifermin Dose Level 4: 720 mcg/kg Intravenous (IV) on Day-73Not reportedNot reportedNot reportedNot reported
Phase 2 Palifermin: 720 mcg/kg Intravenous (IV) Dose16Not reportedNot reportedNot reportedNot reported
Participants Enrolled But Not Treated on Research Phase (Palifermin + Transplant)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        16
      6. group Id
        OG005
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      16
    6. group Id
      OG005
      value
      3
    units
    Participants
description
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
groups
  1. description
    Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
    id
    OG000
    title
    Phase I Palifermin Dose Level 1: 180 mcg/kg Intravenous (IV) on Day-7
  2. description
    Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
    id
    OG001
    title
    Phase I Palifermin Dose Level 2: 360 mcg/kg Intravenous (IV) on Day-7
  3. description
    Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
    id
    OG002
    title
    Phase I Palifermin Dose Level 3: 540 mcg/kg Intravenous (IV) on Day-7
  4. description
    Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
    id
    OG003
    title
    Phase I Palifermin Dose Level 4: 720 mcg/kg Intravenous (IV) on Day-7
  5. description
    Induction chemotherapy, then palifermin at the recommended phase 2 dose (RP2D) determined in Phase 1, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
    id
    OG004
    title
    Phase 2 Palifermin: 720 mcg/kg Intravenous (IV) Dose
  6. description
    Participants were enrolled but not treated on Research Phase (Palifermin + Transplant).
    id
    OG005
    title
    Participants Enrolled But Not Treated on Research Phase (Palifermin + Transplant)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years.
title
Phase I and/or Phase 2: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
type
OTHER_PRE_SPECIFIED
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice