NCT02601950 · STUDY IN CONTEXT

A Study of Tazemetostat in Adult Participants With Soft Tissue Sarcoma

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 because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

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

ORR was defined as percentage of participants who achieved a confirmed complete response (CR) or partial response (PR) based on the investigator review from start of treatment until progressive disease (PD) or start of subsequent anti-cancer therapy or cancer-related surgery, whichever was earlier, as per response assessment in neuro-oncology (RANO) criteria for primary brain tumors or response evaluation criteria in solid tumors (RECIST) version (v) 1.1 criteria for all other solid tumors. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must be \<10 millimeter (mm) in short axis. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as a reference, baseline sum of diameters. PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since treatment started. In addition, sum must have an absolute increase from nadir of 5 mm.

ITT population included all participants who received at least 1 dose of tazemetostat.

→

primary · POSTED

PFS was defined as the interval of time between the date of the first dose of study treatment and the earliest date of PD or death due to any cause, whichever comes first, as per RECIST v 1.1 criteria. PFS rate at 16 week was estimated. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm.

ITT population included all participants who received at least 1 dose of tazemetostat.

→

primary · POSTED

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or was medically significant. TEAEs were defined as AEs if one of the following conditions met: emerged after the time of first dose administration, having been absent prior to the first dose; re-emerged, having been present but stopped prior to the time of first dose administration; worsened in severity after the time of first dose administration relative to the pretreatment state, when the AE was continuous.

Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.

→

secondary · POSTED

DOR was defined as time from the first documented evidence of CR or PR based on investigator review to the time of first documented PD or death due to any cause, whichever came first, as per RECIST v 1.1 criteria. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as a reference, baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm.

ITT population included all participants who received at least 1 dose of tazemetostat. Only those participants with a confirmed CR or PR (responders) were analyzed.

→

secondary · POSTED

PFS was defined as the interval of time between the date of the first dose of study treatment and the earliest date of PD or death due to any cause, whichever comes first, as per RECIST v 1.1 criteria. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm.

ITT population included all participants who received at least 1 dose of tazemetostat.

→

secondary · POSTED

PFS was defined as the interval of time between the date of the first dose of study treatment and the earliest date of PD or death due to any cause, whichever comes first, as per RECIST v 1.1 criteria. PFS rate at 24, 32 and 56 weeks were estimated. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm. Estimates were calculated with Kaplan-Meier analysis and 95% CIs using the complementary log-log transformation.

ITT population included all participants who received at least 1 dose of tazemetostat.

→

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-rhabdoid-tumor
nct id: NCT02601950
trial label: A Study of Tazemetostat in Adult Participants With Soft Tissue Sarcoma
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: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 8
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-rhabdoid-tumor
nct id
NCT02601950
outcome key
om-0000
source section id
NCT02601950-om-0000
source outcome index
0
endpoint
Cohorts 1, 3, 4, 5, 6 and 7: Objective Response Rate (ORR)
endpoint definition
ORR was defined as percentage of participants who achieved a confirmed complete response (CR) or partial response (PR) based on the investigator review from start of treatment until progressive disease (PD) or start of subsequent anti-cancer therapy or cancer-related surgery, whichever was earlier, as per response assessment in neuro-oncology (RANO) criteria for primary brain tumors or response evaluation criteria in solid tumors (RECIST) version (v) 1.1 criteria for all other solid tumors. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must be \<10 millimeter (mm) in short axis. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as a reference, baseline sum of diameters. PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since treatment started. In addition, sum must have an absolute increase from nadir of 5 mm.
time origin
Tumor assessment performed at screening and every 8 weeks beginning at Cycle 3 Day 1, until disease progression or the start of subsequent anti-cancer therapy, whichever occurred first, up to 5.75 years (cycle duration: 28 days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
ITT population included all participants who received at least 1 dose of tazemetostat.
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-rhabdoid-tumor
nct id
NCT02601950
outcome key
om-0001
source section id
NCT02601950-om-0001
source outcome index
1
endpoint
Cohort 2: Progression-Free Survival (PFS) Rate at 16 Weeks of Treatment With Tazemetostat
endpoint definition
PFS was defined as the interval of time between the date of the first dose of study treatment and the earliest date of PD or death due to any cause, whichever comes first, as per RECIST v 1.1 criteria. PFS rate at 16 week was estimated. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm.
time origin
At 16 Weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
ITT population included all participants who received at least 1 dose of tazemetostat.
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-rhabdoid-tumor
nct id
NCT02601950
outcome key
om-0002
source section id
NCT02601950-om-0002
source outcome index
2
endpoint
Cohort 8: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
endpoint definition
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or was medically significant. TEAEs were defined as AEs if one of the following conditions met: emerged after the time of first dose administration, having been absent prior to the first dose; re-emerged, having been present but stopped prior to the time of first dose administration; worsened in severity after the time of first dose administration relative to the pretreatment state, when the AE was continuous.
time origin
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 148 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
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-rhabdoid-tumor
nct id
NCT02601950
outcome key
om-0003
source section id
NCT02601950-om-0003
source outcome index
3
endpoint
All Cohorts: Duration of Response (DOR)
endpoint definition
DOR was defined as time from the first documented evidence of CR or PR based on investigator review to the time of first documented PD or death due to any cause, whichever came first, as per RECIST v 1.1 criteria. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as a reference, baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm.
time origin
Tumor assessment performed at screening and every 8 weeks beginning at Cycle 3 Day 1, until disease progression or the start of subsequent anti-cancer therapy, whichever occurred first, up to 5.75 years (cycle duration 28 days)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT population included all participants who received at least 1 dose of tazemetostat. Only those participants with a confirmed CR or PR (responders) were analyzed.
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-rhabdoid-tumor
nct id
NCT02601950
outcome key
om-0004
source section id
NCT02601950-om-0004
source outcome index
4
endpoint
All Cohorts: Progression-Free Survival (PFS)
endpoint definition
PFS was defined as the interval of time between the date of the first dose of study treatment and the earliest date of PD or death due to any cause, whichever comes first, as per RECIST v 1.1 criteria. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm.
time origin
Tumor assessment performed at screening and every 8 weeks beginning at Cycle 3 Day 1, until disease progression or the start of subsequent anti-cancer therapy, whichever occurred first, up to 5.75 years (cycle duration 28 days)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT population included all participants who received at least 1 dose of tazemetostat.
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-rhabdoid-tumor
nct id
NCT02601950
outcome key
om-0005
source section id
NCT02601950-om-0005
source outcome index
5
endpoint
All Cohorts: Progression-Free Survival (PFS) Rate at Weeks 24, 32 and 56
endpoint definition
PFS was defined as the interval of time between the date of the first dose of study treatment and the earliest date of PD or death due to any cause, whichever comes first, as per RECIST v 1.1 criteria. PFS rate at 24, 32 and 56 weeks were estimated. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as a reference, smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm. Estimates were calculated with Kaplan-Meier analysis and 95% CIs using the complementary log-log transformation.
time origin
At Weeks 24, 32 and 56
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT population included all participants who received at least 1 dose of tazemetostat.
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-rhabdoid-tumor
nct id
NCT02601950
outcome key
om-0000
arm key
OG000
arm label
Rhabdoid Tumors: Cohort 1
regimen
Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
analyzed count
32
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601950-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rhabdoid-tumor
nct id
NCT02601950
outcome key
om-0000
arm key
OG001
arm label
Other INI1-negative: Cohort 3
regimen
Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
analyzed count
32
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601950-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-rhabdoid-tumor
nct id
NCT02601950
outcome key
om-0000
arm key
OG002
arm label
RMC: Cohort 4
regimen
Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601950-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-rhabdoid-tumor
nct id
NCT02601950
outcome key
om-0000
arm key
OG003
arm label
ES: Cohort 5
regimen
Participants with ES received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
analyzed count
62
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601950-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-rhabdoid-tumor
nct id
NCT02601950
outcome key
om-0000
arm key
OG004
arm label
ES Paired Biopsy: Cohort 6
regimen
Participants with ES undergoing optional tumour biopsy received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
analyzed count
69
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601950-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-rhabdoid-tumor
nct id
NCT02601950
outcome key
om-0000
arm key
OG005
arm label
Chordoma: Cohort 7
regimen
Participants with poorly differentiated chordoma (or other chordoma with sponsor approval) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601950-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-rhabdoid-tumor
nct id
NCT02601950
outcome key
om-0001
arm key
OG000
arm label
Synovial Sarcoma: Cohort 2
regimen
Participants with relapsed or refractory synovial sarcoma with SS18-SSX rearrangement received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
analyzed count
33
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601950-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rhabdoid-tumor
nct id
NCT02601950
outcome key
om-0002
arm key
OG000
arm label
ES 1600 mg: Cohort 8
regimen
Participants with ES received tazemetostat 1600 mg QD orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601950-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rhabdoid-tumor
nct id
NCT02601950
outcome key
om-0003
arm key
OG000
arm label
Rhabdoid Tumors: Cohort 1
regimen
Participants with rhabdoid tumors (MRT, RTK, ATRT, and selected tumors with rhabdoid features, including SCCOHT, also known as MRTO) received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601950-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rhabdoid-tumor
nct id
NCT02601950
outcome key
om-0003
arm key
OG001
arm label
Synovial Sarcoma: Cohort 2
regimen
Participants with relapsed or refractory synovial sarcoma with SS18-SSX rearrangement received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601950-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-rhabdoid-tumor
nct id
NCT02601950
outcome key
om-0003
arm key
OG002
arm label
Other INI1-negative: Cohort 3
regimen
Participants with other INI-1-negative tumors or any solid tumor with EZH2 GOF mutation, including EMPNST, EMC, myoepithelial carcinoma, other INI-1-negative malignant tumors with sponsor approval, any solid tumor with EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601950-om-0003#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-rhabdoid-tumor
nct id
NCT02601950
outcome key
om-0003
arm key
OG003
arm label
RMC: Cohort 4
regimen
Participants with RMC received tazemetostat 800 mg BID orally in continuous 28-day cycles until disease progression, development of an unacceptable toxicity, withdrawal of consent, or termination of the study.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02601950-om-0003#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-rhabdoid-tumor
nct id
NCT02601950
harm key
EG000
source section id
NCT02601950-ae
event group key
EG000
event group label
Rhabdoid Tumors: Cohort 1
serious affected
18
serious at risk
32
other affected
27
other at risk
32
frequency threshold
5
collection period
Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
event definition
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
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-rhabdoid-tumor
nct id
NCT02601950
harm key
EG001
source section id
NCT02601950-ae
event group key
EG001
event group label
Synovial Sarcoma: Cohort 2
serious affected
13
serious at risk
33
other affected
28
other at risk
33
frequency threshold
5
collection period
Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
event definition
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
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-rhabdoid-tumor
nct id
NCT02601950
harm key
EG002
source section id
NCT02601950-ae
event group key
EG002
event group label
Other INI1-Negative: Cohort 3
serious affected
11
serious at risk
32
other affected
29
other at risk
32
frequency threshold
5
collection period
Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
event definition
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
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-rhabdoid-tumor
nct id
NCT02601950
harm key
EG003
source section id
NCT02601950-ae
event group key
EG003
event group label
RMC: Cohort 4
serious affected
8
serious at risk
14
other affected
12
other at risk
14
frequency threshold
5
collection period
Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
event definition
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
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-rhabdoid-tumor
nct id
NCT02601950
harm key
EG004
source section id
NCT02601950-ae
event group key
EG004
event group label
ES: Cohort 5
serious affected
25
serious at risk
62
other affected
58
other at risk
62
frequency threshold
5
collection period
Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
event definition
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
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-rhabdoid-tumor
nct id
NCT02601950
harm key
EG005
source section id
NCT02601950-ae
event group key
EG005
event group label
ES Paired Biopsy: Cohort 6
serious affected
19
serious at risk
69
other affected
65
other at risk
69
frequency threshold
5
collection period
Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
event definition
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
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-rhabdoid-tumor
nct id
NCT02601950
harm key
EG006
source section id
NCT02601950-ae
event group key
EG006
event group label
Chordoma: Cohort 7
serious affected
7
serious at risk
18
other affected
16
other at risk
18
frequency threshold
5
collection period
Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
event definition
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
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-rhabdoid-tumor
nct id
NCT02601950
harm key
EG007
source section id
NCT02601950-ae
event group key
EG007
event group label
ES 1600 mg: Cohort 8
serious affected
2
serious at risk
7
other affected
6
other at risk
7
frequency threshold
5
collection period
Treatment-emergent adverse events (TEAEs) were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 88 weeks (Cohort 1), 55 weeks (Cohort 2), 148 weeks (Cohorts 3 and 8), 48 weeks (Cohort 4), 304 weeks (Cohort 5), 270 weeks (Cohort 6) and 183 weeks (Cohort 7). All-cause mortality (deaths) were collected from first dose of study treatment (Day 1) up to 5.75 years.
event definition
Safety population included all participants in the ITT population who had at least 1 post-dose safety observation recorded.
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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