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NCT05185947 · OUTCOME

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis · Source last updated 2026-06-25

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
Day-4 through completion of surveillance post-treatment, up to 2 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 v5.0). 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.

Analysis population: 7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment.

Groups in this outcome

Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1

Ended treatment at the regular dose level: 80 intravenous (IV)/80 Intraperitoneal (IP) + 300 twice a day (BID).

Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1

Had the planned doses for Intraperitoneal (IP) Paclitaxel (80 IP) and by mouth (PO) nilotinib (300 twice a day (BID) but declined to go up to the 80mg/m\^2 of intravenous (IV) Paclitaxel.

Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1

Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD).

Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1

Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD).

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

Analysis denominator · Participants

GroupSource count
Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 14
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 11
Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -11
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -11

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 14Not reportedNot reportedNot reportedNot reported
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 11Not reportedNot reportedNot reportedNot reported
Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -11Not reportedNot reportedNot reportedNot reported
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      1
    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 v5.0). 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
    Ended treatment at the regular dose level: 80 intravenous (IV)/80 Intraperitoneal (IP) + 300 twice a day (BID).
    id
    OG000
    title
    Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
  2. description
    Had the planned doses for Intraperitoneal (IP) Paclitaxel (80 IP) and by mouth (PO) nilotinib (300 twice a day (BID) but declined to go up to the 80mg/m\^2 of intravenous (IV) Paclitaxel.
    id
    OG001
    title
    Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
  3. description
    Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD).
    id
    OG002
    title
    Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1
  4. description
    Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD).
    id
    OG003
    title
    Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1
param Type
COUNT_OF_PARTICIPANTS
population Description
7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment.
reporting Status
POSTED
time Frame
Day-4 through completion of surveillance post-treatment, up to 2 years
title
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
type
OTHER_PRE_SPECIFIED
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice