TriangleNCT02669017 · OUTCOME
Number of Participants Reporting at Least One Treatment Emergent Serious Adverse Event (SAE)
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 to End of Study (a maximum of 18 months)
What was measured
An adverse event (AE) is defined as any untoward medical occurrence in a participant enrolled into this study regardless of its causal relationship to study drug. A treatment emergent AE (TEAE) is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug. An SAE is defined as any event that results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Analysis population: All participants who received at least one dose of study 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 2: 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 2: 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 | 4 |
| Part 1: 90 μg/kg Q3W | 5 |
| Part 1: 120 μg/kg Q3W | 16 |
| Part 2: 120 μg/kg Q3W | 26 |
| Part 1: 150 μg/kg Q3W | 19 |
| Part 2: 150 μg/kg Q3W | 69 |
| Part 1: 200 μg/kg Q3W and Q6W | 36 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: 15 μg/kg Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: 30 μg/kg Q3W | 1 | 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 | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: 120 μg/kg Q3W | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 2: 120 μg/kg Q3W | 14 | Not reported | Not reported | Not reported | Not reported |
| Part 1: 150 μg/kg Q3W | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 2: 150 μg/kg Q3W | 40 | Not reported | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q3W and Q6W | 15 | 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
- 0
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 14
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 40
- group Id
- OG008
- value
- 15
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 16
- group Id
- OG005
- value
- 26
- group Id
- OG006
- value
- 19
- group Id
- OG007
- value
- 69
- group Id
- OG008
- value
- 36
- units
- Participants
- description
- An adverse event (AE) is defined as any untoward medical occurrence in a participant enrolled into this study regardless of its causal relationship to study drug. A treatment emergent AE (TEAE) is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug. An SAE is defined as any event that results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
- 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 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG005
- title
- Part 2: 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
- OG006
- title
- Part 1: 150 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
- OG007
- title
- Part 2: 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
- OG008
- title
- Part 1: 200 μg/kg Q3W and Q6W
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants who received at least one dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Day 1 to End of Study (a maximum of 18 months)
- title
- Number of Participants Reporting at Least One Treatment Emergent Serious Adverse Event (SAE)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice