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NCT00580788 · OUTCOME

Dose Limiting Toxicity (DLT)

One Week Parathyroid Hormone-related Protein (PTHrP) IV Dose Escalation Study · Source last updated 2016-02-11

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
12 hours after the infusion was started then q 8 hours for 7 days

What was measured

DLT was defined as achieving one major criterion or two minor criteria rated at ≥ 2 on a scale of 0-5. The major criteria were defined as symptomatic orthostatic hypotension (systolic BP fall \>30 mm/hg), tachycardia (pulse \> 120), hypertension (systolic BP \>160 mm/hg on 2 occasions), hypercalcemia (serum calcium ≥ 12 mg/dl), and hypophosphatemia (serum phosphorous \< 1.5 mg/dl). Minor criteria included symptoms such as flushing, nausea, abdominal or muscle cramps, dizziness, lightheadedness, palpitations, etc.

Groups in this outcome

Group 1

PTHrP(1-36) 2 picomoles/kg/hr for one week.

Group 2

PTHrP(1-36) 4 picomoles/kg/hr for one week

Group 3

PTHrP(1-36) 5 picomoles/kg/hr for one week

Group 4

PTHrP(1-36) 6 picomoles/kg/hr for one week

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

Analysis denominator · Participants

GroupSource count
Group 13
Group 26
Group 33
Group 42

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group 10Not reportedNot reportedNot reportedNot reported
Group 20Not reportedNot reportedNot reportedNot reported
Group 32Not reportedNot reportedNot reportedNot reported
Group 42Not 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
        2
      4. group Id
        OG003
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      2
    units
    Participants
description
DLT was defined as achieving one major criterion or two minor criteria rated at ≥ 2 on a scale of 0-5. The major criteria were defined as symptomatic orthostatic hypotension (systolic BP fall \>30 mm/hg), tachycardia (pulse \> 120), hypertension (systolic BP \>160 mm/hg on 2 occasions), hypercalcemia (serum calcium ≥ 12 mg/dl), and hypophosphatemia (serum phosphorous \< 1.5 mg/dl). Minor criteria included symptoms such as flushing, nausea, abdominal or muscle cramps, dizziness, lightheadedness, palpitations, etc.
groups
  1. description
    PTHrP(1-36) 2 picomoles/kg/hr for one week.
    id
    OG000
    title
    Group 1
  2. description
    PTHrP(1-36) 4 picomoles/kg/hr for one week
    id
    OG001
    title
    Group 2
  3. description
    PTHrP(1-36) 5 picomoles/kg/hr for one week
    id
    OG002
    title
    Group 3
  4. description
    PTHrP(1-36) 6 picomoles/kg/hr for one week
    id
    OG003
    title
    Group 4
param Type
NUMBER
reporting Status
POSTED
time Frame
12 hours after the infusion was started then q 8 hours for 7 days
title
Dose Limiting Toxicity (DLT)
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice