Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03345485 · OUTCOME

Treatment-related Adverse Events on Phase 2 and Sub Studies

Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors. · Source last updated 2024-10-21

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
From each patient's time of informed consent to discontinuation of study drug (at any time or D28 of the last treatment cycle), up to 8 months

What was measured

Number of patients experiencing treatment-related adverse events (TEAE) as assessed by CTCAE v4.03, June 2010, with the exception that assessment of QTc prolongations constituting adverse events (AEs) of special interest were based on NCI CTCAE version 5.0, November 2017. All subjects who received at least 1 dose of study treatment were included in the Safety Population. Safety analyses were performed on data from all subjects in the Safety Population. Adverse events are reported on a patient basis. The percentages are calculated using the number of patients in the Safety Analysis Set as the denominator.

Analysis population: The safety analysis summarised TEAEs for all treated subjects using discrete summaries at the subject and event level by system organ class (SOC) and preferred term (PT). Treatment-related TEAEs were summarised similarly. TEAEs were also summarised by the grade of National Cancer Institute Common Terminology Criteria for Adverse Events. All AEs were coded using the MedDRA® version 24.0

Groups in this outcome

Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort

Patients with Relapsed/refractory small cell lung cancer (SCLC)

Tinostamustine (EDO-S101) - Phase 2 STS Cohort

Patients with Relapsed/refractory soft tissue sarcoma (STS)

Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort

Patients with Relapsed/refractory triple-negative breast cancer (TNBC)

Tinostamustine (EDO-S101) - Phase 2 OC Cohort

Patients with Relapsed/refractory Ovarian Cancer (OC)

Tinostamustine (EDO-S101) - Phase 2 EC Cohort

Patients with Relapsed/refractory Endometrial Cancer (EC)

Tinostamustine (EDO-S101) - Sub Study 1 (SS1)

Subgroup treated with a dose of 60 mg/m2 over 60 minutes infusion time of EDO-S101

Tinostamustine (EDO-S101) - Sub Study 2 (SS2)

Subgroup treated with a dose of 80 mg/m2 over 80 minutes infusion time of EDO-S101

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

Analysis denominator · Participants

GroupSource count
Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort4
Tinostamustine (EDO-S101) - Phase 2 STS Cohort10
Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort4
Tinostamustine (EDO-S101) - Phase 2 OC Cohort12
Tinostamustine (EDO-S101) - Phase 2 EC Cohort6
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)6
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)7

Reported measurements

Gastrointestinal disorders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort2Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 STS Cohort4Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort3Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 OC Cohort12Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 EC Cohort4Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)2Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)2Not reportedNot reportedNot reportedNot reported
Investigations
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort3Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 STS Cohort3Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort2Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 OC Cohort8Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 EC Cohort5Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)3Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)2Not reportedNot reportedNot reportedNot reported
Blood and lymphatic system disorders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort2Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 STS Cohort4Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort2Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 OC Cohort7Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 EC Cohort3Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)3Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)3Not reportedNot reportedNot reportedNot reported
General disorders and administration site conditions
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort2Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 STS Cohort3Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 OC Cohort9Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 EC Cohort5Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)2Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)1Not reportedNot reportedNot reportedNot reported
Metabolism and nutrition disorders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 STS Cohort1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 OC Cohort4Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 EC Cohort3Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)0Not reportedNot reportedNot reportedNot reported
Nervous system disorders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort2Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 STS Cohort2Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort0Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 OC Cohort3Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 EC Cohort3Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)0Not reportedNot reportedNot reportedNot reported
Skin and subcutaneous tissue disorders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 STS Cohort3Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort0Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 OC Cohort4Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 EC Cohort1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)0Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)0Not reportedNot reportedNot reportedNot reported
Musculoskeletal and connective tissue disorders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 STS Cohort1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort0Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 OC Cohort1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 EC Cohort0Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)1Not reportedNot reportedNot reportedNot reported
Respiratory, thoracic and mediastinal disorders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 STS Cohort1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 OC Cohort0Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 EC Cohort1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)0Not reportedNot reportedNot reportedNot reported
Vascular disorders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort0Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 STS Cohort2Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort0Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 OC Cohort2Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 EC Cohort1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)0Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)0Not reportedNot reportedNot reportedNot reported
Cardiac disorders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort0Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 STS Cohort0Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 OC Cohort1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 EC Cohort1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)0Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)0Not reportedNot reportedNot reportedNot reported
Injury, poisoning and procedural complications
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 STS Cohort0Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 OC Cohort1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 EC Cohort0Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)0Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)0Not reportedNot reportedNot reportedNot reported
Infections and infestations
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort0Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 STS Cohort1Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort0Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 OC Cohort0Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Phase 2 EC Cohort0Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)0Not reportedNot reportedNot reportedNot reported
Tinostamustine (EDO-S101) - Sub Study 2 (SS2)2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        12
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        2
    title
    Gastrointestinal disorders
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        8
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        2
    title
    Investigations
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        3
    title
    Blood and lymphatic system disorders
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        9
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        1
    title
    General disorders and administration site conditions
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
    title
    Metabolism and nutrition disorders
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
    title
    Nervous system disorders
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
    title
    Skin and subcutaneous tissue disorders
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        1
    title
    Musculoskeletal and connective tissue disorders
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
    title
    Respiratory, thoracic and mediastinal disorders
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
    title
    Vascular disorders
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
    title
    Cardiac disorders
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
    title
    Injury, poisoning and procedural complications
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      12
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      7
    units
    Participants
description
Number of patients experiencing treatment-related adverse events (TEAE) as assessed by CTCAE v4.03, June 2010, with the exception that assessment of QTc prolongations constituting adverse events (AEs) of special interest were based on NCI CTCAE version 5.0, November 2017. All subjects who received at least 1 dose of study treatment were included in the Safety Population. Safety analyses were performed on data from all subjects in the Safety Population. Adverse events are reported on a patient basis. The percentages are calculated using the number of patients in the Safety Analysis Set as the denominator.
groups
  1. description
    Patients with Relapsed/refractory small cell lung cancer (SCLC)
    id
    OG000
    title
    Tinostamustine (EDO-S101) - Phase 2 SCLC Cohort
  2. description
    Patients with Relapsed/refractory soft tissue sarcoma (STS)
    id
    OG001
    title
    Tinostamustine (EDO-S101) - Phase 2 STS Cohort
  3. description
    Patients with Relapsed/refractory triple-negative breast cancer (TNBC)
    id
    OG002
    title
    Tinostamustine (EDO-S101) - Phase 2 TNBC Cohort
  4. description
    Patients with Relapsed/refractory Ovarian Cancer (OC)
    id
    OG003
    title
    Tinostamustine (EDO-S101) - Phase 2 OC Cohort
  5. description
    Patients with Relapsed/refractory Endometrial Cancer (EC)
    id
    OG004
    title
    Tinostamustine (EDO-S101) - Phase 2 EC Cohort
  6. description
    Subgroup treated with a dose of 60 mg/m2 over 60 minutes infusion time of EDO-S101
    id
    OG005
    title
    Tinostamustine (EDO-S101) - Sub Study 1 (SS1)
  7. description
    Subgroup treated with a dose of 80 mg/m2 over 80 minutes infusion time of EDO-S101
    id
    OG006
    title
    Tinostamustine (EDO-S101) - Sub Study 2 (SS2)
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety analysis summarised TEAEs for all treated subjects using discrete summaries at the subject and event level by system organ class (SOC) and preferred term (PT). Treatment-related TEAEs were summarised similarly. TEAEs were also summarised by the grade of National Cancer Institute Common Terminology Criteria for Adverse Events. All AEs were coded using the MedDRA® version 24.0
reporting Status
POSTED
time Frame
From each patient's time of informed consent to discontinuation of study drug (at any time or D28 of the last treatment cycle), up to 8 months
title
Treatment-related Adverse Events on Phase 2 and Sub Studies
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice