Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02454972 · OUTCOME

Overall Survival at 6 Months

Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors · Source last updated 2023-03-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
At 6 months

What was measured

Overall Survival at 6 months defined as the probability of being alive after the first infusion at 6 months

Analysis population: Treated patients with disease measurement

Groups in this outcome

Biliary Tract Carcinoma Cohort

Patients with Pathologically proven diagnosis of biliary tract carcinoma

Carcinoma of Unknown Primary Site Cohort

Patients with pathologically proven diagnosis of carcinoma of unknown primary site

Endometrial Carcinoma Cohort

Patients with pathologically proven diagnosis of endometrial carcinoma

Ewing's Family of Tumors Cohort

Patients with pathologically proven diagnosis of Ewing's Family of Tumors

Germ Cell Tumors Cohort

Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.

Head and Neck Carcinoma Cohort

Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.

BRCA1/2-associated Metastatic Breast Carcinoma Cohort

Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma

Neuroendocrine Tumors Cohort

Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.

Small Cell Lung Cancer Cohort

Patients with pathologically proven diagnosis of small cell lung cancer

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

Analysis denominator · Participants

GroupSource count
Biliary Tract Carcinoma Cohort18
Carcinoma of Unknown Primary Site Cohort19
Endometrial Carcinoma Cohort71
Ewing's Family of Tumors Cohort28
Germ Cell Tumors Cohort23
Head and Neck Carcinoma Cohort13
BRCA1/2-associated Metastatic Breast Carcinoma Cohort21
Neuroendocrine Tumors Cohort31
Small Cell Lung Cancer Cohort105

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Biliary Tract Carcinoma Cohort58.2Not reported34.582.0Not reported
Carcinoma of Unknown Primary Site Cohort55.6Not reported32.678.5Not reported
Endometrial Carcinoma Cohort62.8Not reported51.274.4Not reported
Ewing's Family of Tumors Cohort88.2Not reported75.7100.0Not reported
Germ Cell Tumors Cohort55.0Not reported32.877.1Not reported
Head and Neck Carcinoma Cohort38.5Not reported12.064.9Not reported
BRCA1/2-associated Metastatic Breast Carcinoma Cohort79.2Not reported61.097.4Not reported
Neuroendocrine Tumors Cohort52.1Not reported33.970.3Not reported
Small Cell Lung Cancer Cohort68.6Not reported59.577.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        34.5
        upper Limit
        82.0
        value
        58.2
      2. group Id
        OG001
        lower Limit
        32.6
        upper Limit
        78.5
        value
        55.6
      3. group Id
        OG002
        lower Limit
        51.2
        upper Limit
        74.4
        value
        62.8
      4. group Id
        OG003
        lower Limit
        75.7
        upper Limit
        100.0
        value
        88.2
      5. group Id
        OG004
        lower Limit
        32.8
        upper Limit
        77.1
        value
        55.0
      6. group Id
        OG005
        lower Limit
        12.0
        upper Limit
        64.9
        value
        38.5
      7. group Id
        OG006
        lower Limit
        61.0
        upper Limit
        97.4
        value
        79.2
      8. group Id
        OG007
        lower Limit
        33.9
        upper Limit
        70.3
        value
        52.1
      9. group Id
        OG008
        lower Limit
        59.5
        upper Limit
        77.6
        value
        68.6
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    2. group Id
      OG001
      value
      19
    3. group Id
      OG002
      value
      71
    4. group Id
      OG003
      value
      28
    5. group Id
      OG004
      value
      23
    6. group Id
      OG005
      value
      13
    7. group Id
      OG006
      value
      21
    8. group Id
      OG007
      value
      31
    9. group Id
      OG008
      value
      105
    units
    Participants
description
Overall Survival at 6 months defined as the probability of being alive after the first infusion at 6 months
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with Pathologically proven diagnosis of biliary tract carcinoma
    id
    OG000
    title
    Biliary Tract Carcinoma Cohort
  2. description
    Patients with pathologically proven diagnosis of carcinoma of unknown primary site
    id
    OG001
    title
    Carcinoma of Unknown Primary Site Cohort
  3. description
    Patients with pathologically proven diagnosis of endometrial carcinoma
    id
    OG002
    title
    Endometrial Carcinoma Cohort
  4. description
    Patients with pathologically proven diagnosis of Ewing's Family of Tumors
    id
    OG003
    title
    Ewing's Family of Tumors Cohort
  5. description
    Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.
    id
    OG004
    title
    Germ Cell Tumors Cohort
  6. description
    Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.
    id
    OG005
    title
    Head and Neck Carcinoma Cohort
  7. description
    Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma
    id
    OG006
    title
    BRCA1/2-associated Metastatic Breast Carcinoma Cohort
  8. description
    Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.
    id
    OG007
    title
    Neuroendocrine Tumors Cohort
  9. description
    Patients with pathologically proven diagnosis of small cell lung cancer
    id
    OG008
    title
    Small Cell Lung Cancer Cohort
param Type
NUMBER
population Description
Treated patients with disease measurement
reporting Status
POSTED
time Frame
At 6 months
title
Overall Survival at 6 Months
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice