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NCT01098266 · OUTCOME

Number of Partecipants With Adverse Events

NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed · Source last updated 2019-09-17

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
Assessed every 6-12 weeks, up to 100 weeks

What was measured

All adverse events will be recorded according to CTC version 4.02 (CTC reference: http://ctep.cancer.gov/reporting/ctc.html) on the case report forms (CRFs); the investigator will decide if those events are drug related and his decision will be recorded on the forms for all adverse events.

Analysis population: The safety data referred to patients of both arms who received at least one treatment and is termed as safety population (n=386)

Groups in this outcome

A: NGR-hTNF + BIC

NGR-hTNF plus Best Investigator's Choice NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs. * Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis * Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination: 1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles 2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles 3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)

B: Placebo+BIC

Placebo plus Best Investigator's Choice Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs. * Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis * Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination: 1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles 2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles 3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 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
A: NGR-hTNF + BIC193
B: Placebo+BIC193

Reported measurements

Study-emergent AEs of any grade
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A: NGR-hTNF + BIC191Not reportedNot reportedNot reportedNot reported
B: Placebo+BIC185Not reportedNot reportedNot reportedNot reported
Study-emergent AEs of grade 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A: NGR-hTNF + BIC102Not reportedNot reportedNot reportedNot reported
B: Placebo+BIC86Not reportedNot reportedNot reportedNot reported
Study-emergent AEs of grade 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A: NGR-hTNF + BIC22Not reportedNot reportedNot reportedNot reported
B: Placebo+BIC19Not reportedNot reportedNot reportedNot reported
Study-emergent AEs of grade 5
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A: NGR-hTNF + BIC12Not reportedNot reportedNot reportedNot reported
B: Placebo+BIC13Not reportedNot reportedNot reportedNot reported
Treatment-related AEs of grade 5
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A: NGR-hTNF + BIC0Not reportedNot reportedNot reportedNot reported
B: Placebo+BIC0Not reportedNot reportedNot reportedNot reported
Treatment discontinuation due to AEs
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A: NGR-hTNF + BIC31Not reportedNot reportedNot reportedNot reported
B: Placebo+BIC24Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        191
      2. group Id
        OG001
        value
        185
    title
    Study-emergent AEs of any grade
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        102
      2. group Id
        OG001
        value
        86
    title
    Study-emergent AEs of grade 3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        19
    title
    Study-emergent AEs of grade 4
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        13
    title
    Study-emergent AEs of grade 5
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Treatment-related AEs of grade 5
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        31
      2. group Id
        OG001
        value
        24
    title
    Treatment discontinuation due to AEs
denoms
  1. counts
    1. group Id
      OG000
      value
      193
    2. group Id
      OG001
      value
      193
    units
    Participants
description
All adverse events will be recorded according to CTC version 4.02 (CTC reference: http://ctep.cancer.gov/reporting/ctc.html) on the case report forms (CRFs); the investigator will decide if those events are drug related and his decision will be recorded on the forms for all adverse events.
groups
  1. description
    NGR-hTNF plus Best Investigator's Choice NGR-hTNF plus Best Investigator's Choice (BIC): - NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs. * Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis * Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination: 1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles 2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles 3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
    id
    OG000
    title
    A: NGR-hTNF + BIC
  2. description
    Placebo plus Best Investigator's Choice Placebo plus Best Investigator's Choice (BIC): - Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs. * Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis * Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination: 1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles 2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles 3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)
    id
    OG001
    title
    B: Placebo+BIC
param Type
NUMBER
population Description
The safety data referred to patients of both arms who received at least one treatment and is termed as safety population (n=386)
reporting Status
POSTED
time Frame
Assessed every 6-12 weeks, up to 100 weeks
title
Number of Partecipants With Adverse Events
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice