NCT02988817 · STUDY IN CONTEXT

Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With 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

The DLTs were defined as Grade (G) 4 neutropenia or G4 thrombocytopenia for a minimal duration of 7 days, G3 and G4 febrile neutropenia, \>=G3 hemorrhage associated with \>=G3 thrombocytopenia, G4 anemia; Stevens Johnson syndrome, toxic epidermal necrolysis, \>=G3 cutaneous vasculitis; G3 neuropathy (not improved to G1 within 3 weeks following pausing of dosing) and G4 neuropathy; G3 infusion-related reactions (IRR) that did not resolve to G1 or baseline within 24 hours; G4 IRR or G4 anaphylaxis events; \>= G3 diarrhoea and/or vomiting persisting \>48 hours or G3 nausea lasting 7 days (both despite optimal medical management); or any \>=G3 related non-hematological AEs, which occurred during the Cycle 1 and regarded as medically important as assessed by the Data Monitoring Committee (excluding Grade 3 fatigue or non-hematological laboratory abnormalities as specified in protocol).

Dose-determining set included all participants from the Safety Set (participants who received at least 1 dose of enapotamab vedotin, had at least one valid post-baseline safety assessment, and were classified according to first dose received) who either met the minimum exposure criterion and completed the DLT observation period, or who experienced a DLT during Cycle 1.

→

primary · POSTED

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is defined as an AE that meets one of the following criteria: requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, is a congenital anomaly/birth defect, is medically important, results in death, or is life-threatening. In this trial, a TEAE was defined as an AE occurring or worsening between the first dose of enapotamab vedotin and 30 days after the last dose received.

The safety set included all participants who received at least 1 dose of enapotamab vedotin and had at least one valid post-baseline safety assessment. Participants were classified according to first dose received.

→

primary · POSTED

Number of participants with treatment-emergent infusion-related AEs and TEAEs related to enapotamab vedotin is reported.

→

primary · POSTED

Number of participants with TEAEs of \>= Grade 3 as assessed by NCI-CTCAE v4.03 is reported. The NCI-CTCAE is a descriptive terminology is used for AE reporting. The NCI-CTCAE v4.03 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE, based on this general guideline: Grade 1 as mild AE, Grade 2 as moderate AE, Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death. If a participant reported multiple severity grades for an AE, only the maximum grade was used.

→

secondary · POSTED

The AUC0-inf of conjugated enapotamab vedotin for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.

Pharmacokinetic (PK) analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.

→

secondary · POSTED

The AUC0-last of conjugated enapotamab vedotin for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.

The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.

→

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-thyroid-cancer
nct id: NCT02988817
trial label: Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With 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: 20
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT02988817
outcome key
om-0000
source section id
NCT02988817-om-0000
source outcome index
0
endpoint
Number of Participants With Dose-limiting Toxicities (DLTs) for Dose-escalation Part
endpoint definition
The DLTs were defined as Grade (G) 4 neutropenia or G4 thrombocytopenia for a minimal duration of 7 days, G3 and G4 febrile neutropenia, \>=G3 hemorrhage associated with \>=G3 thrombocytopenia, G4 anemia; Stevens Johnson syndrome, toxic epidermal necrolysis, \>=G3 cutaneous vasculitis; G3 neuropathy (not improved to G1 within 3 weeks following pausing of dosing) and G4 neuropathy; G3 infusion-related reactions (IRR) that did not resolve to G1 or baseline within 24 hours; G4 IRR or G4 anaphylaxis events; \>= G3 diarrhoea and/or vomiting persisting \>48 hours or G3 nausea lasting 7 days (both despite optimal medical management); or any \>=G3 related non-hematological AEs, which occurred during the Cycle 1 and regarded as medically important as assessed by the Data Monitoring Committee (excluding Grade 3 fatigue or non-hematological laboratory abnormalities as specified in protocol).
time origin
From Day 1 to Day 21 of first cycle for 1Q3W dosing regimen and from Day 1 to Day 28 of first cycle for 3Q4W dosing regimen
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Dose-determining set included all participants from the Safety Set (participants who received at least 1 dose of enapotamab vedotin, had at least one valid post-baseline safety assessment, and were classified according to first dose received) who either met the minimum exposure criterion and completed the DLT observation period, or who experienced a DLT during Cycle 1.
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-thyroid-cancer
nct id
NCT02988817
outcome key
om-0001
source section id
NCT02988817-om-0001
source outcome index
1
endpoint
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
endpoint definition
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is defined as an AE that meets one of the following criteria: requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, is a congenital anomaly/birth defect, is medically important, results in death, or is life-threatening. In this trial, a TEAE was defined as an AE occurring or worsening between the first dose of enapotamab vedotin and 30 days after the last dose received.
time origin
Day 1 through Day 1130 (maximum observed duration)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The safety set included all participants who received at least 1 dose of enapotamab vedotin and had at least one valid post-baseline safety assessment. Participants were classified according to first dose received.
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-thyroid-cancer
nct id
NCT02988817
outcome key
om-0002
source section id
NCT02988817-om-0002
source outcome index
2
endpoint
Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin
endpoint definition
Number of participants with treatment-emergent infusion-related AEs and TEAEs related to enapotamab vedotin is reported.
time origin
Day 1 through Day 1130 (maximum observed duration)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The safety set included all participants who received at least 1 dose of enapotamab vedotin and had at least one valid post-baseline safety assessment. Participants were classified according to first dose received.
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-thyroid-cancer
nct id
NCT02988817
outcome key
om-0003
source section id
NCT02988817-om-0003
source outcome index
3
endpoint
Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03
endpoint definition
Number of participants with TEAEs of \>= Grade 3 as assessed by NCI-CTCAE v4.03 is reported. The NCI-CTCAE is a descriptive terminology is used for AE reporting. The NCI-CTCAE v4.03 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE, based on this general guideline: Grade 1 as mild AE, Grade 2 as moderate AE, Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death. If a participant reported multiple severity grades for an AE, only the maximum grade was used.
time origin
Day 1 through Day 1130 (maximum observed duration)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The safety set included all participants who received at least 1 dose of enapotamab vedotin and had at least one valid post-baseline safety assessment. Participants were classified according to first dose received.
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-thyroid-cancer
nct id
NCT02988817
outcome key
om-0004
source section id
NCT02988817-om-0004
source outcome index
4
endpoint
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part
endpoint definition
The AUC0-inf of conjugated enapotamab vedotin for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
time origin
Predose, end of infusion (EOI), and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Pharmacokinetic (PK) analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
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-thyroid-cancer
nct id
NCT02988817
outcome key
om-0005
source section id
NCT02988817-om-0005
source outcome index
5
endpoint
Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part
endpoint definition
The AUC0-last of conjugated enapotamab vedotin for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.
time origin
Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The PK analysis set included all participants who were exposed to at least 1 dose of enapotamab vedotin and who had at least 1 postdose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
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-thyroid-cancer
nct id
NCT02988817
outcome key
om-0000
arm key
OG000
arm label
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
regimen
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02988817-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT02988817
outcome key
om-0000
arm key
OG001
arm label
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
regimen
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02988817-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT02988817
outcome key
om-0000
arm key
OG002
arm label
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
regimen
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02988817-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT02988817
outcome key
om-0000
arm key
OG003
arm label
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
regimen
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02988817-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT02988817
outcome key
om-0000
arm key
OG004
arm label
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
regimen
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02988817-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT02988817
outcome key
om-0000
arm key
OG005
arm label
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
regimen
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02988817-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT02988817
outcome key
om-0000
arm key
OG006
arm label
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
regimen
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02988817-om-0000#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT02988817
outcome key
om-0000
arm key
OG007
arm label
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
regimen
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02988817-om-0000#groups/OG007
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT02988817
outcome key
om-0000
arm key
OG008
arm label
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
regimen
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02988817-om-0000#groups/OG008
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT02988817
outcome key
om-0000
arm key
OG009
arm label
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
regimen
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02988817-om-0000#groups/OG009
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT02988817
outcome key
om-0000
arm key
OG010
arm label
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
regimen
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02988817-om-0000#groups/OG010
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT02988817
outcome key
om-0001
arm key
OG000
arm label
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
regimen
Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02988817-om-0001#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT02988817
harm key
EG000
source section id
NCT02988817-ae
event group key
EG000
event group label
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
serious affected
0
serious at risk
1
other affected
1
other at risk
1
frequency threshold
0
collection period
For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
event definition
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
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-thyroid-cancer
nct id
NCT02988817
harm key
EG001
source section id
NCT02988817-ae
event group key
EG001
event group label
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
serious affected
0
serious at risk
1
other affected
1
other at risk
1
frequency threshold
0
collection period
For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
event definition
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
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-thyroid-cancer
nct id
NCT02988817
harm key
EG002
source section id
NCT02988817-ae
event group key
EG002
event group label
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
event definition
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
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-thyroid-cancer
nct id
NCT02988817
harm key
EG003
source section id
NCT02988817-ae
event group key
EG003
event group label
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
event definition
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
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-thyroid-cancer
nct id
NCT02988817
harm key
EG004
source section id
NCT02988817-ae
event group key
EG004
event group label
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
serious affected
7
serious at risk
10
other affected
10
other at risk
10
frequency threshold
0
collection period
For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
event definition
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
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-thyroid-cancer
nct id
NCT02988817
harm key
EG005
source section id
NCT02988817-ae
event group key
EG005
event group label
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
serious affected
6
serious at risk
11
other affected
11
other at risk
11
frequency threshold
0
collection period
For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
event definition
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
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-thyroid-cancer
nct id
NCT02988817
harm key
EG006
source section id
NCT02988817-ae
event group key
EG006
event group label
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
event definition
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
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-thyroid-cancer
nct id
NCT02988817
harm key
EG007
source section id
NCT02988817-ae
event group key
EG007
event group label
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
event definition
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
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-thyroid-cancer
nct id
NCT02988817
harm key
EG008
source section id
NCT02988817-ae
event group key
EG008
event group label
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
event definition
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
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-thyroid-cancer
nct id
NCT02988817
harm key
EG009
source section id
NCT02988817-ae
event group key
EG009
event group label
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
serious affected
2
serious at risk
6
other affected
6
other at risk
6
frequency threshold
0
collection period
For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
event definition
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
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-thyroid-cancer
nct id
NCT02988817
harm key
EG010
source section id
NCT02988817-ae
event group key
EG010
event group label
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
serious affected
3
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
event definition
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
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-thyroid-cancer
nct id
NCT02988817
harm key
EG011
source section id
NCT02988817-ae
event group key
EG011
event group label
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
serious affected
15
serious at risk
22
other affected
22
other at risk
22
frequency threshold
0
collection period
For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
event definition
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
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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