TriangleNCT03621982 · OUTCOME
Number of Participants Who Experienced a SAE by CTCAE Grade
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
- Up to 3 years
What was measured
AEs were graded according to CTCAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE was graded on a scale of 1 is mild or asymptomatic, 2 is moderate, 3 is severe, 4 is Life-threatening and 5 is death related to an AE.
Analysis population: Safety Analysis Set: The Safety analysis set consists of all participants who received study drug. Analysis only included participants with SAEs.
Groups in this outcome
ADCT-301 Monotherapy 20 µg/kg
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
ADCT-301 Monotherapy 30 µg/kg
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
ADCT-301 Monotherapy 45 µg/kg
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
ADCT-301 Monotherapy 60 µg/kg
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
ADCT-301 Monotherapy 80 µg/kg
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
ADCT-301 Monotherapy 100 µg/kg
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
ADCT-301 Monotherapy 125 µg/kg
Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
ADCT-301 Monotherapy 150 µg/kg
Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
ADCT-301 Combination Therapy 20 µg/kg + Pemb
Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
ADCT-301 Combination Therapy 30 µg/kg + Pemb
Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
ADCT-301 Combination Therapy 45 µg/kg + Pemb
Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
ADCT-301 Combination Therapy 60 µg/kg + Pemb
Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
ADCT-301 Combination Therapy 80 µg/kg + Pemb
Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
ADCT-301 Combination Therapy 100 µg/kg + Pemb
Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
| Group | Source count |
|---|---|
| ADCT-301 Monotherapy 20 µg/kg | 2 |
| ADCT-301 Monotherapy 30 µg/kg | 1 |
| ADCT-301 Monotherapy 45 µg/kg | 2 |
| ADCT-301 Monotherapy 60 µg/kg | 3 |
| ADCT-301 Monotherapy 80 µg/kg | 3 |
| ADCT-301 Monotherapy 100 µg/kg | 1 |
| ADCT-301 Monotherapy 125 µg/kg | 3 |
| ADCT-301 Monotherapy 150 µg/kg | 3 |
| ADCT-301 Combination Therapy 20 µg/kg + Pemb | 1 |
| ADCT-301 Combination Therapy 30 µg/kg + Pemb | 3 |
| ADCT-301 Combination Therapy 45 µg/kg + Pemb | 5 |
| ADCT-301 Combination Therapy 60 µg/kg + Pemb | 8 |
| ADCT-301 Combination Therapy 80 µg/kg + Pemb | 2 |
| ADCT-301 Combination Therapy 100 µg/kg + Pemb | 5 |
Reported measurements
Grade 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ADCT-301 Monotherapy 20 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 30 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 45 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 60 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 80 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 100 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 125 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 150 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 20 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 30 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 45 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 60 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 80 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 100 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ADCT-301 Monotherapy 20 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 30 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 45 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 60 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 80 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 100 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 125 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 150 µg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 20 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 30 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 45 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 60 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 80 µg/kg + Pemb | 1 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 100 µg/kg + Pemb | 1 | Not reported | Not reported | Not reported | Not reported |
Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ADCT-301 Monotherapy 20 µg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 30 µg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 45 µg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 60 µg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 80 µg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 100 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 125 µg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 150 µg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 20 µg/kg + Pemb | 1 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 30 µg/kg + Pemb | 2 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 45 µg/kg + Pemb | 5 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 60 µg/kg + Pemb | 7 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 80 µg/kg + Pemb | 1 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 100 µg/kg + Pemb | 4 | Not reported | Not reported | Not reported | Not reported |
Grade 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ADCT-301 Monotherapy 20 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 30 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 45 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 60 µg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 80 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 100 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 125 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 150 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 20 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 30 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 45 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 60 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 80 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 100 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
Grade 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ADCT-301 Monotherapy 20 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 30 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 45 µg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 60 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 80 µg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 100 µg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 125 µg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 150 µg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 20 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 30 µg/kg + Pemb | 1 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 45 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 60 µg/kg + Pemb | 1 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 80 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 100 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
Missing
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ADCT-301 Monotherapy 20 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 30 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 45 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 60 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 80 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 100 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 125 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 150 µg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 20 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 30 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 45 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 60 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 80 µg/kg + Pemb | 0 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 100 µg/kg + Pemb | 0 | 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
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Grade 1
- 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
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Grade 2
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 7
- title
- Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Grade 4
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 1
- title
- Grade 5
- 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
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Missing
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 8
- units
- Participants
- description
- AEs were graded according to CTCAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE was graded on a scale of 1 is mild or asymptomatic, 2 is moderate, 3 is severe, 4 is Life-threatening and 5 is death related to an AE.
- groups
- description
- Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- id
- OG000
- title
- ADCT-301 Monotherapy 20 µg/kg
- description
- Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- id
- OG001
- title
- ADCT-301 Monotherapy 30 µg/kg
- description
- Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- id
- OG002
- title
- ADCT-301 Monotherapy 45 µg/kg
- description
- Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- id
- OG003
- title
- ADCT-301 Monotherapy 60 µg/kg
- description
- Participants received 80 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- id
- OG004
- title
- ADCT-301 Monotherapy 80 µg/kg
- description
- Participants received 100 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- id
- OG005
- title
- ADCT-301 Monotherapy 100 µg/kg
- description
- Participants received 125 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- id
- OG006
- title
- ADCT-301 Monotherapy 125 µg/kg
- description
- Participants received 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle.
- id
- OG007
- title
- ADCT-301 Monotherapy 150 µg/kg
- description
- Participants received 20 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
- id
- OG008
- title
- ADCT-301 Combination Therapy 20 µg/kg + Pemb
- description
- Participants received 30 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
- id
- OG009
- title
- ADCT-301 Combination Therapy 30 µg/kg + Pemb
- description
- Participants received 45 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
- id
- OG010
- title
- ADCT-301 Combination Therapy 45 µg/kg + Pemb
- description
- Participants received 60 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle and Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion).
- id
- OG011
- title
- ADCT-301 Combination Therapy 60 µg/kg + Pemb
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Analysis Set: The Safety analysis set consists of all participants who received study drug. Analysis only included participants with SAEs.
- reporting Status
- POSTED
- time Frame
- Up to 3 years
- title
- Number of Participants Who Experienced a SAE by CTCAE Grade
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice