TriangleNCT02988817 · OUTCOME
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Day 1 through Day 1130 (maximum observed duration)
What was measured
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.
Analysis population: 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.
Groups in this outcome
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
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.
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
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.
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
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.
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
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.
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
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.
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
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.
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
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.
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
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.
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
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.
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
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.
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
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.
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W
Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
| Group | Source count |
|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | 1 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | 10 |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 11 |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | 3 |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 6 |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | 3 |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 22 |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 16 |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 25 |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 25 |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 44 |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 25 |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 56 |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | 20 |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 26 |
Reported measurements
Any TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | 10 | Not reported | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 11 | Not reported | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | 3 | Not reported | Not reported | Not reported | Not reported |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 22 | Not reported | Not reported | Not reported | Not reported |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 16 | Not reported | Not reported | Not reported | Not reported |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 25 | Not reported | Not reported | Not reported | Not reported |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 25 | Not reported | Not reported | Not reported | Not reported |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 44 | Not reported | Not reported | Not reported | Not reported |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 25 | Not reported | Not reported | Not reported | Not reported |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 56 | Not reported | Not reported | Not reported | Not reported |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | 20 | Not reported | Not reported | Not reported | Not reported |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 26 | Not reported | Not reported | Not reported | Not reported |
Any TESAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W | 7 | Not reported | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W | 3 | Not reported | Not reported | Not reported | Not reported |
| Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 15 | Not reported | Not reported | Not reported | Not reported |
| Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 5 | Not reported | Not reported | Not reported | Not reported |
| Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 16 | Not reported | Not reported | Not reported | Not reported |
| Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 10 | Not reported | Not reported | Not reported | Not reported |
| Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 16 | Not reported | Not reported | Not reported | Not reported |
| Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 12 | Not reported | Not reported | Not reported | Not reported |
| Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W | 33 | Not reported | Not reported | Not reported | Not reported |
| Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W | 7 | Not reported | Not reported | Not reported | Not reported |
| Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W | 14 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 22
- title
- Any TEAE
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 15
- title
- Any TESAE
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 6
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 22
- units
- Participants
- description
- 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.
- groups
- description
- 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.
- id
- OG000
- title
- Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
- description
- 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.
- id
- OG001
- title
- Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
- description
- 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.
- id
- OG002
- title
- Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
- description
- 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.
- id
- OG003
- title
- Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
- description
- 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.
- id
- OG004
- title
- Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
- description
- 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.
- id
- OG005
- title
- Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
- description
- 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.
- id
- OG006
- title
- Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
- description
- 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.
- id
- OG007
- title
- Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
- description
- 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.
- id
- OG008
- title
- Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
- description
- 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.
- id
- OG009
- title
- Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
- description
- 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.
- id
- OG010
- title
- Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
- description
- Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
- id
- OG011
- title
- Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- 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.
- reporting Status
- POSTED
- time Frame
- Day 1 through Day 1130 (maximum observed duration)
- title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice