TriangleNCT03621982 · OUTCOME
Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (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 to 5, where 1 is asymptomatic or mild symptoms, 2 is moderate, 3 is severe, 4 is Life-threatening consequences 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 and experienced TEAEs only.
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 | 3 |
| ADCT-301 Monotherapy 30 µg/kg | 5 |
| ADCT-301 Monotherapy 45 µg/kg | 5 |
| ADCT-301 Monotherapy 60 µg/kg | 5 |
| ADCT-301 Monotherapy 80 µg/kg | 8 |
| ADCT-301 Monotherapy 100 µg/kg | 7 |
| ADCT-301 Monotherapy 125 µg/kg | 8 |
| ADCT-301 Monotherapy 150 µg/kg | 3 |
| ADCT-301 Combination Therapy 20 µg/kg + Pemb | 1 |
| ADCT-301 Combination Therapy 30 µg/kg + Pemb | 4 |
| ADCT-301 Combination Therapy 45 µg/kg + Pemb | 10 |
| ADCT-301 Combination Therapy 60 µg/kg + Pemb | 9 |
| ADCT-301 Combination Therapy 80 µg/kg + Pemb | 4 |
| ADCT-301 Combination Therapy 100 µg/kg + Pemb | 6 |
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 | 1 | 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 | 2 | 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 | 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 | 1 | 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 | 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 | 1 | 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 | 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 | 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 | 2 | 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 | 2 | 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 | 3 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 30 µg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 45 µg/kg | 3 | 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 | 5 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 100 µg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 125 µg/kg | 4 | 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 | 7 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 60 µg/kg + Pemb | 6 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 80 µg/kg + Pemb | 2 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 100 µg/kg + Pemb | 5 | 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 | 1 | 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 | 2 | 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
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 0
- title
- Grade 1
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 2
- group Id
- OG011
- value
- 0
- title
- Grade 2
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 7
- group Id
- OG011
- value
- 6
- 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
- 1
- 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
- 2
- 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
- 3
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 10
- group Id
- OG011
- value
- 9
- 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 to 5, where 1 is asymptomatic or mild symptoms, 2 is moderate, 3 is severe, 4 is Life-threatening consequences 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 and experienced TEAEs only.
- reporting Status
- POSTED
- time Frame
- Up to 3 years
- title
- Number of Participants Who Experienced TEAEs by Common Terminology Criteria for Adverse Events (CTCAE) Grade
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice