TriangleNCT02669017 · OUTCOME
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
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
- Q3W schedule: Day 1 to End of Cycle 1 (3 weeks); Q6W schedule: Day 1 to End of Cycle 1 (6 weeks)
What was measured
A DLT is defined as any of the following events, except those that are clearly due to underlying disease or extraneous causes: A hematologic DLT is defined as: * CTCAE Grade 3 or 4 febrile neutropenia or neutropenic infection. * CTCAE Grade 4 neutropenia lasting \>7 days. * CTCAE Grade 4 thrombocytopenia. * CTCAE Grade 3 thrombocytopenia with clinically significant bleeding, or Grade 3 thrombocytopenia requiring a platelet transfusion. * CTCAE Grade 4 anemia. A non-hematologic DLT is defined as: * CTCAE Grade 4 tumor lysis syndrome (TLS). Grade 3 TLS will not constitute DLT unless it leads to irreversible end-organ damage. * CTCAE Grade 3 or higher AE (including nausea, vomiting, diarrhea, and electrolyte imbalances lasting more than 48 hours despite optimal therapy; excluding all grades of alopecia). * CTCAE Grade 3 or higher hypersensitivity reaction (regardless of premedication). * CTCAE Grade 2 or higher skin ulceration.
Analysis population: All participants in Part 1 who completed at least one cycle of treatment.
Groups in this outcome
Part 1: 15 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Part 1: 30 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Part 1: 60 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Part 1: 90 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Part 1: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Part 1: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Part 1: 200 μg/kg Q3W and Q6W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
| Group | Source count |
|---|---|
| Part 1: 15 μg/kg Q3W | 4 |
| Part 1: 30 μg/kg Q3W | 4 |
| Part 1: 60 μg/kg Q3W | 3 |
| Part 1: 90 μg/kg Q3W | 5 |
| Part 1: 120 μg/kg Q3W | 16 |
| Part 1: 150 μg/kg Q3W | 16 |
| Part 1: 200 μg/kg Q3W and Q6W | 25 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: 15 μg/kg Q3W | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: 30 μg/kg Q3W | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: 60 μg/kg Q3W | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: 90 μg/kg Q3W | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: 120 μg/kg Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: 150 μg/kg Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q3W and Q6W | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 16
- group Id
- OG005
- value
- 16
- group Id
- OG006
- value
- 25
- units
- Participants
- description
- A DLT is defined as any of the following events, except those that are clearly due to underlying disease or extraneous causes: A hematologic DLT is defined as: * CTCAE Grade 3 or 4 febrile neutropenia or neutropenic infection. * CTCAE Grade 4 neutropenia lasting \>7 days. * CTCAE Grade 4 thrombocytopenia. * CTCAE Grade 3 thrombocytopenia with clinically significant bleeding, or Grade 3 thrombocytopenia requiring a platelet transfusion. * CTCAE Grade 4 anemia. A non-hematologic DLT is defined as: * CTCAE Grade 4 tumor lysis syndrome (TLS). Grade 3 TLS will not constitute DLT unless it leads to irreversible end-organ damage. * CTCAE Grade 3 or higher AE (including nausea, vomiting, diarrhea, and electrolyte imbalances lasting more than 48 hours despite optimal therapy; excluding all grades of alopecia). * CTCAE Grade 3 or higher hypersensitivity reaction (regardless of premedication). * CTCAE Grade 2 or higher skin ulceration.
- groups
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG000
- title
- Part 1: 15 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG001
- title
- Part 1: 30 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG002
- title
- Part 1: 60 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG003
- title
- Part 1: 90 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG004
- title
- Part 1: 120 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG005
- title
- Part 1: 150 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
- id
- OG006
- title
- Part 1: 200 μg/kg Q3W and Q6W
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants in Part 1 who completed at least one cycle of treatment.
- reporting Status
- POSTED
- time Frame
- Q3W schedule: Day 1 to End of Cycle 1 (3 weeks); Q6W schedule: Day 1 to End of Cycle 1 (6 weeks)
- title
- Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice