NCT02460224 · OUTCOME
Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. · Source last updated 2022-02-10
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 2.7 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 with AEs and SAEs is reported for each tumor type.
Analysis population: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
Groups in this outcome
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 121 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 21 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 93 |
|---|
Reported measurements
AEs, Non-small cell lung cancer (NSCLC)
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 20 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 22 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 22 | Not reported | Not reported | Not reported | Not reported |
|---|
SAEs, Non-small cell lung cancer (NSCLC)
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 20 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 22 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
AEs, Melanoma
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 20 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 22 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 22 | Not reported | Not reported | Not reported | Not reported |
|---|
SAEs, Melanoma
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 20 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 22 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
AEs, Renal cell cancer (RCC)
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 19 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 19 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
SAEs, Renal cell cancer (RCC)
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 19 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 19 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
AEs, Mesothelioma
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 41 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 16 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 41 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
SAEs, Mesothelioma
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 41 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 16 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
AEs, Triple negative breast cancer (TNBC)
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 21 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 21 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 14 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
SAEs, Triple negative breast cancer (TNBC)
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 21 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 21 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 14 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG002
- value
- 22
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 22
- units
- Participants
- title
- AEs, Non-small cell lung cancer (NSCLC)
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG002
- value
- 7
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 22
- units
- Participants
- title
- SAEs, Non-small cell lung cancer (NSCLC)
- categories
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG002
- value
- 22
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 22
- units
- Participants
- title
- AEs, Melanoma
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG002
- value
- 8
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 22
- units
- Participants
- title
- SAEs, Melanoma
- categories
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG002
- value
- 19
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 19
- units
- Participants
- title
- AEs, Renal cell cancer (RCC)
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG002
- value
- 5
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 19
- units
- Participants
- title
- SAEs, Renal cell cancer (RCC)
- categories
- measurements
- group Id
- OG000
- value
- 41
- group Id
- OG002
- value
- 16
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 16
- units
- Participants
- title
- AEs, Mesothelioma
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG002
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 16
- units
- Participants
- title
- SAEs, Mesothelioma
- categories
- measurements
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 14
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 14
- units
- Participants
- title
- AEs, Triple negative breast cancer (TNBC)
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 14
- units
- Participants
- title
- SAEs, Triple negative breast cancer (TNBC)
- denoms
- counts
- group Id
- OG000
- value
- 121
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 93
- 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 with AEs and SAEs is reported for each tumor type.
- groups
- description
- Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
- id
- OG000
- title
- Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W
- description
- Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
- id
- OG001
- title
- Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W
- description
- Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
- id
- OG002
- title
- Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All patients in phase 2 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 2.7 years.
- title
- Phase 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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