TriangleNCT03621982 · OUTCOME
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
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
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy, whichever is earlier. Any clinically significant changes from baseline in the safety laboratory values, vital signs, 12-lead electrocardiogram (ECG), and Eastern Cooperative Oncology Group (ECOG) performance status were reported as TEAEs.
Analysis population: Safety Analysis Set: The Safety analysis set consists of all participants who received study drug.
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 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 100 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).
| 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
Source class 1
| 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 | 5 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 45 µg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 60 µg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 80 µg/kg | 8 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 100 µg/kg | 7 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 125 µg/kg | 8 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Monotherapy 150 µg/kg | 3 | 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 | 4 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 45 µg/kg + Pemb | 10 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 60 µg/kg + Pemb | 9 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 80 µg/kg + Pemb | 4 | Not reported | Not reported | Not reported | Not reported |
| ADCT-301 Combination Therapy 100 µg/kg + Pemb | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- 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
- 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
- An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy, whichever is earlier. Any clinically significant changes from baseline in the safety laboratory values, vital signs, 12-lead electrocardiogram (ECG), and Eastern Cooperative Oncology Group (ECOG) performance status were reported as TEAEs.
- 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.
- reporting Status
- POSTED
- time Frame
- Up to 3 years
- title
- Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice