NCT03345485 · STUDY IN CONTEXT

Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors.

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

All TEAEs was reported from the first dose of study drug through the time of study drug discontinuation (at any time or Day 28 of the last treatment Cycle). All treatment-related TEAEs was followed until resolution or stabilization. For the purpose of regulatory reporting requirements, causal relationships of definite, probable, and possible was considered treatment-related. Number of patients experiencing treatment-related adverse events (TEAE) as assessed by CTCAE v4.03. (June 2010).

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

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primary · POSTED

The Clinical Benefit Response Rate is calculated as the number of patients with Clinical Benefit Response divided by number of patients in the FAS (in the respective cohort). Clinical Benefit Response is defined as patients achieving stable disease with a duration of at least 12 weeks (84 days). Summary subjects analysed were 36.

All subjects who received at least 1 dose of study treatment were included in the Full Analysis (FA) Population. Efficacy analyses were performed on data from all subjects in the FA Population

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primary · POSTED

QTcF: corrected QT interval \[QTc\] using Fridericia's formula) and other electrocardiogram (ECG) parameters in subjects with solid tumours who have progressed after at least 1 line of therapy and for whom no other standard therapy with proven clinical benefit is available. Within each cycle a Change from baseline (CfB) is calculated for QTcF relative to the baseline value of day 1 of the cycle. QTcF CfB= QTcF Post-dose value - QTcF pre-dose value of D1 ECG Parameters: 4-hours ECG holter monitoring in C1 and ECGs during EDO-S101 administration. Continuous variables the mean and standard deviation are presented together with the total number of observations and the number of missing and non-missing values.

Source null

→

secondary · POSTED

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.

→

secondary · POSTED

PFS was defined as the number of days between the date of the first dose of treatment of a patient and the first date of disease progression, start of a subsequent anti-cancer therapy, or death of the patient.

Source null

→

secondary · POSTED

Overall survival is defined as the number days between the date of the first dose of treatment and the date of death. If no date of death is recorded the Overall Survival time is censored at the Last available visit date. Phase 2: To determine the overall survival (OS) time for subjects with solid tumours. SS1:To determine the overall survival (OS) time for subjects who received 60 mg/m2 of EDO-S101 during a 60-minute Infusion. SS2: To determine the overall survival (OS) time for subjects who received 80 mg/m2 of EDO-S101 during a 80-minute Infusion.

Full Analysis Set (FAS): All patients who received at least 1 dose of trial treatment and had at least 1 post-baseline response evaluation.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-small-cell-lung-cancer
nct id: NCT03345485
trial label: Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors.
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 13
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
outcome key
om-0000
source section id
NCT03345485-om-0000
source outcome index
0
endpoint
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE V4.03 on Phase 1
endpoint definition
All TEAEs was reported from the first dose of study drug through the time of study drug discontinuation (at any time or Day 28 of the last treatment Cycle). All treatment-related TEAEs was followed until resolution or stabilization. For the purpose of regulatory reporting requirements, causal relationships of definite, probable, and possible was considered treatment-related. Number of patients experiencing treatment-related adverse events (TEAE) as assessed by CTCAE v4.03. (June 2010).
time origin
From each patient's time of first dose administration to discontinuation of study drug (at any time or D28 of the last treatment cycle), up to 6 months.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
outcome key
om-0001
source section id
NCT03345485-om-0001
source outcome index
1
endpoint
Clinical Benefit Response Rate in Selected Solid Tumor Cohorts on Phase 2
endpoint definition
The Clinical Benefit Response Rate is calculated as the number of patients with Clinical Benefit Response divided by number of patients in the FAS (in the respective cohort). Clinical Benefit Response is defined as patients achieving stable disease with a duration of at least 12 weeks (84 days). Summary subjects analysed were 36.
time origin
From start treatment and assessed after every 2 cycles until determination of stable disease and follow up for up to 84 days.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All subjects who received at least 1 dose of study treatment were included in the Full Analysis (FA) Population. Efficacy analyses were performed on data from all subjects in the FA Population
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
outcome key
om-0002
source section id
NCT03345485-om-0002
source outcome index
2
endpoint
Highest Change From Baseline in QTcF in Sub-studies
endpoint definition
QTcF: corrected QT interval \[QTc\] using Fridericia's formula) and other electrocardiogram (ECG) parameters in subjects with solid tumours who have progressed after at least 1 line of therapy and for whom no other standard therapy with proven clinical benefit is available. Within each cycle a Change from baseline (CfB) is calculated for QTcF relative to the baseline value of day 1 of the cycle. QTcF CfB= QTcF Post-dose value - QTcF pre-dose value of D1 ECG Parameters: 4-hours ECG holter monitoring in C1 and ECGs during EDO-S101 administration. Continuous variables the mean and standard deviation are presented together with the total number of observations and the number of missing and non-missing values.
time origin
From cycle 1 and at every cycle on treatment days D1 and D15, assessed pre-dose and post-start of infusion at 30 and 80mins (Substudy 2 - up to 6 months) and 30, 60, 90, 120 and 180mins (substudy 1 - up to 6 months).
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
outcome key
om-0003
source section id
NCT03345485-om-0003
source outcome index
3
endpoint
Treatment-related Adverse Events on Phase 2 and Sub Studies
endpoint definition
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.
time origin
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
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
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
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
outcome key
om-0004
source section id
NCT03345485-om-0004
source outcome index
4
endpoint
Progression Free Survival (PFS) Time for Phase 2 and Sub Studies
endpoint definition
PFS was defined as the number of days between the date of the first dose of treatment of a patient and the first date of disease progression, start of a subsequent anti-cancer therapy, or death of the patient.
time origin
From patient's first dose until first documented progression/start of subsequent anti-cancer therapy/death from any cause, whichever came first, up to 26 months.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
outcome key
om-0005
source section id
NCT03345485-om-0005
source outcome index
5
endpoint
Overall Survival (OS) Time for Phase 2 and Sub Studies
endpoint definition
Overall survival is defined as the number days between the date of the first dose of treatment and the date of death. If no date of death is recorded the Overall Survival time is censored at the Last available visit date. Phase 2: To determine the overall survival (OS) time for subjects with solid tumours. SS1:To determine the overall survival (OS) time for subjects who received 60 mg/m2 of EDO-S101 during a 60-minute Infusion. SS2: To determine the overall survival (OS) time for subjects who received 80 mg/m2 of EDO-S101 during a 80-minute Infusion.
time origin
From patient's first dose until first documented progression/start of subsequent anti-cancer therapy/death from any cause, whichever came first, up to 42 months.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Full Analysis Set (FAS): All patients who received at least 1 dose of trial treatment and had at least 1 post-baseline response evaluation.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
outcome key
om-0000
arm key
OG000
arm label
Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min) Cohort 1
regimen
Patients who received Tinostamustine at 60mg/m2 (30min) on D1 and D15 of a 4-week cycle
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345485-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
outcome key
om-0000
arm key
OG001
arm label
Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min) Cohort 2
regimen
Patients who received Tinostamustine at 80mg/m2 (30min) on D1 and D15 of a 4-week cycle
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345485-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
outcome key
om-0000
arm key
OG002
arm label
Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min) Cohort 3
regimen
Patients who received Tinostamustine at 100mg/m2 (30min) on D1 and D15 of a 4-week cycle
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345485-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
outcome key
om-0000
arm key
OG003
arm label
Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min) Cohort 4
regimen
Patients who received Tinostamustine at 60mg/m2 (60min) on D1 and D15 of a 4-week cycle
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345485-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
outcome key
om-0000
arm key
OG004
arm label
Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min) Cohort 5
regimen
Patients who received Tinostamustine at 80mg/m2 (60min) on D1 and D15 of a 4-week cycle
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345485-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
outcome key
om-0000
arm key
OG005
arm label
Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min) Cohort 6
regimen
Patients who received Tinostamustine at 100mg/m2 (60min) on D1 and D15 of a 4-week cycle
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345485-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
outcome key
om-0001
arm key
OG000
arm label
Tinostamustine (EDO-S101) - Phase 2 SCLC
regimen
A dose of study treatment at 80 mg/m2 administered over 1 hour in patients with relapsed/refractory small cell lung cancer.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345485-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
outcome key
om-0001
arm key
OG001
arm label
Tinostamustine (EDO-S101) - Phase 2 STS
regimen
A dose of study treatment at 80 mg/m2 administered over 1 hour in in patients with relapsed/refractory soft tissue sarcoma.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345485-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
outcome key
om-0001
arm key
OG002
arm label
Tinostamustine (EDO-S101) - Phase 2 TNBC
regimen
A dose of study treatment at 80 mg/m2 administered over 1 hour in patients with relapsed/refractory Triple-negative breast cancer.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345485-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
outcome key
om-0001
arm key
OG003
arm label
Tinostamustine (EDO-S101) - Phase 2 OC
regimen
A dose of study treatment at 80 mg/m2 administered over 1 hour in patients with relapsed/refractory Ovarian Cancer.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345485-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
outcome key
om-0001
arm key
OG004
arm label
Tinostamustine (EDO-S101) - Phase 2 EC
regimen
A dose of study treatment at 80 mg/m2 administered over 1 hour in patients with relapsed/refractory Endometrial Cancer.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345485-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
outcome key
om-0002
arm key
OG000
arm label
Tinostamustine (EDO-S101) - Sub Study 1 (SS1)
regimen
6 Patients treated with 60 mg/m2 as a single agent of Tinostamustine administered over 60 minutes infusion time
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03345485-om-0002#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
harm key
EG000
source section id
NCT03345485-ae
event group key
EG000
event group label
Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (30 Min) Cohort 1
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Phase (P) 1: From time of first dose to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation/resolution (up to 33 months). P2 and Substudies (SS): From point of ICF signature to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation or resolution (P2 and SS1 -up to 49 months) or (SS2 up to 18 months).
event definition
TEAE will be captured from the first day of study drug dosing through discontinuation of study drug (at any time or Day 28 of the last treatment cycle). Serious adverse events (SAEs) will be reported from first day of study drug until 30 days after last treatment. P1: All AEs were coded using the MedDRA® version 24.0 and P2 using the MedDRA® version 20.0.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
harm key
EG001
source section id
NCT03345485-ae
event group key
EG001
event group label
Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (30 Min) Cohort 2
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Phase (P) 1: From time of first dose to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation/resolution (up to 33 months). P2 and Substudies (SS): From point of ICF signature to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation or resolution (P2 and SS1 -up to 49 months) or (SS2 up to 18 months).
event definition
TEAE will be captured from the first day of study drug dosing through discontinuation of study drug (at any time or Day 28 of the last treatment cycle). Serious adverse events (SAEs) will be reported from first day of study drug until 30 days after last treatment. P1: All AEs were coded using the MedDRA® version 24.0 and P2 using the MedDRA® version 20.0.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
harm key
EG002
source section id
NCT03345485-ae
event group key
EG002
event group label
Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (30 Min) Cohort 3
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Phase (P) 1: From time of first dose to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation/resolution (up to 33 months). P2 and Substudies (SS): From point of ICF signature to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation or resolution (P2 and SS1 -up to 49 months) or (SS2 up to 18 months).
event definition
TEAE will be captured from the first day of study drug dosing through discontinuation of study drug (at any time or Day 28 of the last treatment cycle). Serious adverse events (SAEs) will be reported from first day of study drug until 30 days after last treatment. P1: All AEs were coded using the MedDRA® version 24.0 and P2 using the MedDRA® version 20.0.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
harm key
EG003
source section id
NCT03345485-ae
event group key
EG003
event group label
Tinostamustine (EDO-S101) - Phase 1 - 60mg/m2 (60 Min) Cohort 4
serious affected
3
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Phase (P) 1: From time of first dose to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation/resolution (up to 33 months). P2 and Substudies (SS): From point of ICF signature to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation or resolution (P2 and SS1 -up to 49 months) or (SS2 up to 18 months).
event definition
TEAE will be captured from the first day of study drug dosing through discontinuation of study drug (at any time or Day 28 of the last treatment cycle). Serious adverse events (SAEs) will be reported from first day of study drug until 30 days after last treatment. P1: All AEs were coded using the MedDRA® version 24.0 and P2 using the MedDRA® version 20.0.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
harm key
EG004
source section id
NCT03345485-ae
event group key
EG004
event group label
Tinostamustine (EDO-S101) - Phase 1 - 80mg/m2 (60 Min) Cohort 5
serious affected
5
serious at risk
8
other affected
8
other at risk
8
frequency threshold
0
collection period
Phase (P) 1: From time of first dose to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation/resolution (up to 33 months). P2 and Substudies (SS): From point of ICF signature to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation or resolution (P2 and SS1 -up to 49 months) or (SS2 up to 18 months).
event definition
TEAE will be captured from the first day of study drug dosing through discontinuation of study drug (at any time or Day 28 of the last treatment cycle). Serious adverse events (SAEs) will be reported from first day of study drug until 30 days after last treatment. P1: All AEs were coded using the MedDRA® version 24.0 and P2 using the MedDRA® version 20.0.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
harm key
EG005
source section id
NCT03345485-ae
event group key
EG005
event group label
Tinostamustine (EDO-S101) - Phase 1 - 100mg/m2 (60 Min) Cohort 6
serious affected
2
serious at risk
2
other affected
2
other at risk
2
frequency threshold
0
collection period
Phase (P) 1: From time of first dose to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation/resolution (up to 33 months). P2 and Substudies (SS): From point of ICF signature to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation or resolution (P2 and SS1 -up to 49 months) or (SS2 up to 18 months).
event definition
TEAE will be captured from the first day of study drug dosing through discontinuation of study drug (at any time or Day 28 of the last treatment cycle). Serious adverse events (SAEs) will be reported from first day of study drug until 30 days after last treatment. P1: All AEs were coded using the MedDRA® version 24.0 and P2 using the MedDRA® version 20.0.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
harm key
EG006
source section id
NCT03345485-ae
event group key
EG006
event group label
Tinostamustine (EDO-S101) - Phase 2 SCLC
serious affected
0
serious at risk
4
other affected
4
other at risk
4
frequency threshold
0
collection period
Phase (P) 1: From time of first dose to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation/resolution (up to 33 months). P2 and Substudies (SS): From point of ICF signature to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation or resolution (P2 and SS1 -up to 49 months) or (SS2 up to 18 months).
event definition
TEAE will be captured from the first day of study drug dosing through discontinuation of study drug (at any time or Day 28 of the last treatment cycle). Serious adverse events (SAEs) will be reported from first day of study drug until 30 days after last treatment. P1: All AEs were coded using the MedDRA® version 24.0 and P2 using the MedDRA® version 20.0.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
harm key
EG007
source section id
NCT03345485-ae
event group key
EG007
event group label
Tinostamustine (EDO-S101) - Phase 2 STS
serious affected
6
serious at risk
10
other affected
10
other at risk
10
frequency threshold
0
collection period
Phase (P) 1: From time of first dose to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation/resolution (up to 33 months). P2 and Substudies (SS): From point of ICF signature to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation or resolution (P2 and SS1 -up to 49 months) or (SS2 up to 18 months).
event definition
TEAE will be captured from the first day of study drug dosing through discontinuation of study drug (at any time or Day 28 of the last treatment cycle). Serious adverse events (SAEs) will be reported from first day of study drug until 30 days after last treatment. P1: All AEs were coded using the MedDRA® version 24.0 and P2 using the MedDRA® version 20.0.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
harm key
EG008
source section id
NCT03345485-ae
event group key
EG008
event group label
Tinostamustine (EDO-S101) - Phase 2 TNBC
serious affected
1
serious at risk
4
other affected
4
other at risk
4
frequency threshold
0
collection period
Phase (P) 1: From time of first dose to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation/resolution (up to 33 months). P2 and Substudies (SS): From point of ICF signature to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation or resolution (P2 and SS1 -up to 49 months) or (SS2 up to 18 months).
event definition
TEAE will be captured from the first day of study drug dosing through discontinuation of study drug (at any time or Day 28 of the last treatment cycle). Serious adverse events (SAEs) will be reported from first day of study drug until 30 days after last treatment. P1: All AEs were coded using the MedDRA® version 24.0 and P2 using the MedDRA® version 20.0.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
harm key
EG009
source section id
NCT03345485-ae
event group key
EG009
event group label
Tinostamustine (EDO-S101) - Phase 2 OC
serious affected
7
serious at risk
12
other affected
12
other at risk
12
frequency threshold
0
collection period
Phase (P) 1: From time of first dose to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation/resolution (up to 33 months). P2 and Substudies (SS): From point of ICF signature to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation or resolution (P2 and SS1 -up to 49 months) or (SS2 up to 18 months).
event definition
TEAE will be captured from the first day of study drug dosing through discontinuation of study drug (at any time or Day 28 of the last treatment cycle). Serious adverse events (SAEs) will be reported from first day of study drug until 30 days after last treatment. P1: All AEs were coded using the MedDRA® version 24.0 and P2 using the MedDRA® version 20.0.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
harm key
EG010
source section id
NCT03345485-ae
event group key
EG010
event group label
Tinostamustine (EDO-S101) - Phase 2 EC
serious affected
4
serious at risk
6
other affected
6
other at risk
6
frequency threshold
0
collection period
Phase (P) 1: From time of first dose to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation/resolution (up to 33 months). P2 and Substudies (SS): From point of ICF signature to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation or resolution (P2 and SS1 -up to 49 months) or (SS2 up to 18 months).
event definition
TEAE will be captured from the first day of study drug dosing through discontinuation of study drug (at any time or Day 28 of the last treatment cycle). Serious adverse events (SAEs) will be reported from first day of study drug until 30 days after last treatment. P1: All AEs were coded using the MedDRA® version 24.0 and P2 using the MedDRA® version 20.0.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03345485
harm key
EG011
source section id
NCT03345485-ae
event group key
EG011
event group label
Tinostamustine (EDO-S101) - Sub Study (SS1)
serious affected
6
serious at risk
6
other affected
6
other at risk
6
frequency threshold
0
collection period
Phase (P) 1: From time of first dose to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation/resolution (up to 33 months). P2 and Substudies (SS): From point of ICF signature to study drug discontinuation (at any time or Day 28 of the last treatment cycle), followed up to stabilisation or resolution (P2 and SS1 -up to 49 months) or (SS2 up to 18 months).
event definition
TEAE will be captured from the first day of study drug dosing through discontinuation of study drug (at any time or Day 28 of the last treatment cycle). Serious adverse events (SAEs) will be reported from first day of study drug until 30 days after last treatment. P1: All AEs were coded using the MedDRA® version 24.0 and P2 using the MedDRA® version 20.0.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

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Preserved source evidence · Not medical advice