TriangleNCT02460224 · OUTCOME
Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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
- From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 4.5 years.
What was measured
Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The number of participants in each category (Rest of the World (ROW) patients, Japanese patients) with AEs and SAEs are reported in this record.
Analysis population: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
Groups in this outcome
Phase 1: LAG525 1 mg/kg Q2W
Single-agent LAG525 1 mg/kg Q2W
Phase 1: LAG525 3 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
Phase 1: LAG525 5 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
| Group | Source count |
|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | 17 |
| Phase 1: LAG525 3 mg/kg Q2W | 12 |
| Phase 1: LAG525 5 mg/kg Q2W | 6 |
| Phase 1: LAG525 10 mg/kg Q2W | 6 |
| Phase 1: LAG525 15 mg/kg Q2W | 6 |
| Phase 1: LAG525 240 mg Q2W | 30 |
| Phase 1: LAG525 400 mg Q2W | 30 |
| Phase 1: LAG525 3 mg/kg Q4W | 5 |
| Phase 1: LAG525 5 mg/kg Q4W | 6 |
| Phase 1: LAG525 10 mg/kg Q4W | 11 |
| Phase 1: LAG525 400 mg Q4W | 5 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | 6 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | 5 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | 6 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | 20 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | 6 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | 12 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | 7 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | 6 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | 12 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | 11 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | 6 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | 6 |
Reported measurements
AEs, ROW patients
| Group | Source count |
|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | 13 |
| Phase 1: LAG525 3 mg/kg Q2W | 12 |
| Phase 1: LAG525 5 mg/kg Q2W | 6 |
| Phase 1: LAG525 10 mg/kg Q2W | 6 |
| Phase 1: LAG525 15 mg/kg Q2W | 6 |
| Phase 1: LAG525 240 mg Q2W | 25 |
| Phase 1: LAG525 400 mg Q2W | 24 |
| Phase 1: LAG525 3 mg/kg Q4W | 5 |
| Phase 1: LAG525 5 mg/kg Q4W | 6 |
| Phase 1: LAG525 10 mg/kg Q4W | 11 |
| Phase 1: LAG525 400 mg Q4W | 5 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | 6 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | 5 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | 6 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | 20 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | 6 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | 12 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | 7 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | 6 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | 12 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | 11 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | 6 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | 13 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 3 mg/kg Q2W | 11 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 5 mg/kg Q2W | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 10 mg/kg Q2W | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 15 mg/kg Q2W | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q2W | 24 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q2W | 24 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 3 mg/kg Q4W | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 5 mg/kg Q4W | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 10 mg/kg Q4W | 11 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q4W | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | 19 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | 12 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | 12 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | 11 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | 6 | Not reported | Not reported | Not reported | Not reported |
SAEs, ROW patients
| Group | Source count |
|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | 13 |
| Phase 1: LAG525 3 mg/kg Q2W | 12 |
| Phase 1: LAG525 5 mg/kg Q2W | 6 |
| Phase 1: LAG525 10 mg/kg Q2W | 6 |
| Phase 1: LAG525 15 mg/kg Q2W | 6 |
| Phase 1: LAG525 240 mg Q2W | 25 |
| Phase 1: LAG525 400 mg Q2W | 24 |
| Phase 1: LAG525 3 mg/kg Q4W | 5 |
| Phase 1: LAG525 5 mg/kg Q4W | 6 |
| Phase 1: LAG525 10 mg/kg Q4W | 11 |
| Phase 1: LAG525 400 mg Q4W | 5 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | 6 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | 5 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | 6 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | 20 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | 6 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | 12 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | 7 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | 6 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | 12 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | 11 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | 6 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 3 mg/kg Q2W | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 5 mg/kg Q2W | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 10 mg/kg Q2W | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 15 mg/kg Q2W | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q2W | 10 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q2W | 11 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 3 mg/kg Q4W | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 5 mg/kg Q4W | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 10 mg/kg Q4W | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q4W | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | 9 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | 4 | Not reported | Not reported | Not reported | Not reported |
AEs, Japanese patients
| Group | Source count |
|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | 4 |
| Phase 1: LAG525 3 mg/kg Q2W | 0 |
| Phase 1: LAG525 5 mg/kg Q2W | 0 |
| Phase 1: LAG525 10 mg/kg Q2W | 0 |
| Phase 1: LAG525 15 mg/kg Q2W | 0 |
| Phase 1: LAG525 240 mg Q2W | 5 |
| Phase 1: LAG525 400 mg Q2W | 6 |
| Phase 1: LAG525 3 mg/kg Q4W | 0 |
| Phase 1: LAG525 5 mg/kg Q4W | 0 |
| Phase 1: LAG525 10 mg/kg Q4W | 0 |
| Phase 1: LAG525 400 mg Q4W | 0 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | 0 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | 0 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 0 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | 0 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | 0 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | 0 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | 0 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | 0 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | 0 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | 0 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | 0 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 0 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | 0 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | 0 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q2W | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q2W | 6 | Not reported | Not reported | Not reported | Not reported |
SAEs, Japanese patients
| Group | Source count |
|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | 4 |
| Phase 1: LAG525 3 mg/kg Q2W | 0 |
| Phase 1: LAG525 5 mg/kg Q2W | 0 |
| Phase 1: LAG525 10 mg/kg Q2W | 0 |
| Phase 1: LAG525 15 mg/kg Q2W | 0 |
| Phase 1: LAG525 240 mg Q2W | 5 |
| Phase 1: LAG525 400 mg Q2W | 6 |
| Phase 1: LAG525 3 mg/kg Q4W | 0 |
| Phase 1: LAG525 5 mg/kg Q4W | 0 |
| Phase 1: LAG525 10 mg/kg Q4W | 0 |
| Phase 1: LAG525 400 mg Q4W | 0 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | 0 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | 0 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 0 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | 0 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | 0 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | 0 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | 0 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | 0 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | 0 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | 0 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | 0 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 0 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | 0 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | 0 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q2W | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q2W | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 24
- group Id
- OG006
- value
- 24
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 11
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 6
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 25
- group Id
- OG006
- value
- 24
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 11
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 6
- units
- Participants
- title
- AEs, ROW patients
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 5
- group Id
- OG010
- value
- 2
- group Id
- OG011
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 25
- group Id
- OG006
- value
- 24
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 11
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 6
- units
- Participants
- title
- SAEs, ROW patients
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 6
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 6
- 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
- units
- Participants
- title
- AEs, Japanese patients
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 6
- 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
- units
- Participants
- title
- SAEs, Japanese patients
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 30
- group Id
- OG006
- value
- 30
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 11
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 6
- units
- Participants
- description
- Number of participants with AEs and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs. The number of participants in each category (Rest of the World (ROW) patients, Japanese patients) with AEs and SAEs are reported in this record.
- groups
- description
- Single-agent LAG525 1 mg/kg Q2W
- id
- OG000
- title
- Phase 1: LAG525 1 mg/kg Q2W
- description
- Single-agent LAG525 3 mg/kg Q2W
- id
- OG001
- title
- Phase 1: LAG525 3 mg/kg Q2W
- description
- Single-agent LAG525 5 mg/kg Q2W
- id
- OG002
- title
- Phase 1: LAG525 5 mg/kg Q2W
- description
- Single-agent LAG525 10 mg/kg Q2W
- id
- OG003
- title
- Phase 1: LAG525 10 mg/kg Q2W
- description
- Single-agent LAG525 15 mg/kg Q2W
- id
- OG004
- title
- Phase 1: LAG525 15 mg/kg Q2W
- description
- Single-agent LAG525 240 mg Q2W
- id
- OG005
- title
- Phase 1: LAG525 240 mg Q2W
- description
- Single-agent LAG525 400 mg Q2W
- id
- OG006
- title
- Phase 1: LAG525 400 mg Q2W
- description
- Single-agent LAG525 3 mg/kg Q4W
- id
- OG007
- title
- Phase 1: LAG525 3 mg/kg Q4W
- description
- Single-agent LAG525 5 mg/kg Q4W
- id
- OG008
- title
- Phase 1: LAG525 5 mg/kg Q4W
- description
- Single-agent LAG525 10 mg/kg Q4W
- id
- OG009
- title
- Phase 1: LAG525 10 mg/kg Q4W
- description
- Single-agent LAG525 400 mg Q4W
- id
- OG010
- title
- Phase 1: LAG525 400 mg Q4W
- description
- Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
- id
- OG011
- title
- Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001.
- reporting Status
- POSTED
- time Frame
- From first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed up to 4.5 years.
- title
- Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice