Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01842646 · OUTCOME

Number of Participants With Treatment Emergent Adverse Events

Phase II Hedgehog Inhibitor for Myelodysplastic Syndrome (MDS) · Source last updated 2021-06-14

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
2 years, 4 months

What was measured

Treatment emergent adverse events occurring in equal to or more than 10% of participants.

Analysis population: All participants

Groups in this outcome

Experimental: PF-04449913 Treatment

Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.

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

Analysis denominator · Participants

GroupSource count
Experimental: PF-04449913 Treatment35

Reported measurements

Grade 1-2 : Pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment22Not reportedNot reportedNot reportedNot reported
Grade 1-2 : Dysgeusia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment21Not reportedNot reportedNot reportedNot reported
Grade 1-2 : Nausea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment11Not reportedNot reportedNot reportedNot reported
Grade 1-2 : Anorexia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment11Not reportedNot reportedNot reportedNot reported
Grade 1-2 : Skin/rash
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment8Not reportedNot reportedNot reportedNot reported
Grade 1-2 : Oral mucositis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment9Not reportedNot reportedNot reportedNot reported
Grade 1-2 : AST elevated
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment8Not reportedNot reportedNot reportedNot reported
Grade 1-2 : Alopecia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment8Not reportedNot reportedNot reportedNot reported
Grade 1-2 : ALT elevated
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment6Not reportedNot reportedNot reportedNot reported
Grade 1-2 : Dizziness
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment6Not reportedNot reportedNot reportedNot reported
Grade 1-2 : Dyspnea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment5Not reportedNot reportedNot reportedNot reported
Grade 1-2 : Infections
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment2Not reportedNot reportedNot reportedNot reported
Grade 1-2 : Fatigue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment6Not reportedNot reportedNot reportedNot reported
Grade 1-2 : Diarrhea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment6Not reportedNot reportedNot reportedNot reported
Grade 1-2 : Constipation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment5Not reportedNot reportedNot reportedNot reported
Grade 1-2 : Fever
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment5Not reportedNot reportedNot reportedNot reported
Grade 1-2 : Hyperkalemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment5Not reportedNot reportedNot reportedNot reported
Grade 1-2 : Hyperglycemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment4Not reportedNot reportedNot reportedNot reported
Grade 1-2 : Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment2Not reportedNot reportedNot reportedNot reported
Grade 1-2 : Headache
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment4Not reportedNot reportedNot reportedNot reported
Grade 1-2 : Vomiting
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment4Not reportedNot reportedNot reportedNot reported
Grade 3-4 : Pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment1Not reportedNot reportedNot reportedNot reported
Grade 3-4 : Dysgeusia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment0Not reportedNot reportedNot reportedNot reported
Grade 3-4 : Nausea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment0Not reportedNot reportedNot reportedNot reported
Grade 3-4 : Anorexia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment0Not reportedNot reportedNot reportedNot reported
Grade 3-4 : Skin/rash
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment1Not reportedNot reportedNot reportedNot reported
Grade 3-4 : Oral mucositis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment0Not reportedNot reportedNot reportedNot reported
Grade 3-4 : AST elevated
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment0Not reportedNot reportedNot reportedNot reported
Grade 3-4 : Alopecia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment0Not reportedNot reportedNot reportedNot reported
Grade 3-4 : ALT elevated
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment0Not reportedNot reportedNot reportedNot reported
Grade 3-4 : Dizziness
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment0Not reportedNot reportedNot reportedNot reported
Grade 3-4 : Dyspnea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment1Not reportedNot reportedNot reportedNot reported
Grade 3-4 : Infections
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment4Not reportedNot reportedNot reportedNot reported
Grade 3-4 : Fatigue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment0Not reportedNot reportedNot reportedNot reported
Grade 3-4 : Diarrhea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment0Not reportedNot reportedNot reportedNot reported
Grade 3-4 : Constipation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment0Not reportedNot reportedNot reportedNot reported
Grade 3-4 : Fever
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment0Not reportedNot reportedNot reportedNot reported
Grade 3-4 : Hyperkalemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment0Not reportedNot reportedNot reportedNot reported
Grade 3-4 : Hyperglycemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment0Not reportedNot reportedNot reportedNot reported
Grade 3-4 : Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment2Not reportedNot reportedNot reportedNot reported
Grade 3-4 : Headache
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment0Not reportedNot reportedNot reportedNot reported
Grade 3-4 : Vomiting
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PF-04449913 Treatment0Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        22
    title
    Grade 1-2 : Pain
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        21
    title
    Grade 1-2 : Dysgeusia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    Grade 1-2 : Nausea
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    Grade 1-2 : Anorexia
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Grade 1-2 : Skin/rash
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Grade 1-2 : Oral mucositis
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Grade 1-2 : AST elevated
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Grade 1-2 : Alopecia
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Grade 1-2 : ALT elevated
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Grade 1-2 : Dizziness
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Grade 1-2 : Dyspnea
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Grade 1-2 : Infections
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    units
    Participants
description
Treatment emergent adverse events occurring in equal to or more than 10% of participants.
groups
  1. description
    Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
    id
    OG000
    title
    Experimental: PF-04449913 Treatment
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants
reporting Status
POSTED
time Frame
2 years, 4 months
title
Number of Participants With Treatment Emergent Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice