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NCT02460224 · OUTCOME

Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001

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 start of treatment until end of treatment, assessed up to 4.4 years.

What was measured

Number of participants with at least one dose reduction of LAG525, at least one dose interruption of LAG525, at least one dose reduction of PDR001 and at least one dose interruption of PDR001. Japanese patients were not treated with PDR001 and therefore the dose reductions and dose interruptions of this study drug are not applicable.

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 1: LAG525 1 mg/kg Q2W17
Phase 1: LAG525 3 mg/kg Q2W12
Phase 1: LAG525 5 mg/kg Q2W6
Phase 1: LAG525 10 mg/kg Q2W6
Phase 1: LAG525 15 mg/kg Q2W6
Phase 1: LAG525 240 mg Q2W30
Phase 1: LAG525 400 mg Q2W30
Phase 1: LAG525 3 mg/kg Q4W5
Phase 1: LAG525 5 mg/kg Q4W6
Phase 1: LAG525 10 mg/kg Q4W11
Phase 1: LAG525 400 mg Q4W5
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W6
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W6
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W6
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W5
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W6
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W20
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W6
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W12
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W7
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W6
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W12
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W6
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W11
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W6
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W6

Reported measurements

LAG525 dose reduction, ROW patients

Analysis denominator · Participants

GroupSource count
Phase 1: LAG525 1 mg/kg Q2W13
Phase 1: LAG525 3 mg/kg Q2W12
Phase 1: LAG525 5 mg/kg Q2W6
Phase 1: LAG525 10 mg/kg Q2W6
Phase 1: LAG525 15 mg/kg Q2W6
Phase 1: LAG525 240 mg Q2W25
Phase 1: LAG525 400 mg Q2W24
Phase 1: LAG525 3 mg/kg Q4W5
Phase 1: LAG525 5 mg/kg Q4W6
Phase 1: LAG525 10 mg/kg Q4W11
Phase 1: LAG525 400 mg Q4W5
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W6
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W6
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W6
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W5
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W6
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W20
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W6
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W12
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W7
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W6
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W12
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W6
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W11
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W6
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W6
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: LAG525 1 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 3 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 5 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 10 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 15 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 240 mg Q2W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 400 mg Q2W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 3 mg/kg Q4W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 5 mg/kg Q4W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 10 mg/kg Q4W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 400 mg Q4W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W1Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W1Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W0Not reportedNot reportedNot reportedNot reported
LAG525 dose interruption, ROW patients

Analysis denominator · Participants

GroupSource count
Phase 1: LAG525 1 mg/kg Q2W13
Phase 1: LAG525 3 mg/kg Q2W12
Phase 1: LAG525 5 mg/kg Q2W6
Phase 1: LAG525 10 mg/kg Q2W6
Phase 1: LAG525 15 mg/kg Q2W6
Phase 1: LAG525 240 mg Q2W25
Phase 1: LAG525 400 mg Q2W24
Phase 1: LAG525 3 mg/kg Q4W5
Phase 1: LAG525 5 mg/kg Q4W6
Phase 1: LAG525 10 mg/kg Q4W11
Phase 1: LAG525 400 mg Q4W5
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W6
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W6
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W6
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W5
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W6
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W20
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W6
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W12
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W7
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W6
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W12
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W6
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W11
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W6
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W6
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: LAG525 1 mg/kg Q2W2Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 3 mg/kg Q2W2Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 5 mg/kg Q2W1Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 10 mg/kg Q2W1Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 15 mg/kg Q2W1Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 240 mg Q2W1Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 400 mg Q2W1Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 3 mg/kg Q4W1Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 5 mg/kg Q4W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 10 mg/kg Q4W2Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 400 mg Q4W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W4Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W1Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W2Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W1Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W1Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W6Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W2Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W2Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W1Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W2Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W3Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W4Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W1Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W1Not reportedNot reportedNot reportedNot reported
PDR001 dose reduction, ROW patients

Analysis denominator · Participants

GroupSource count
Phase 1: LAG525 1 mg/kg Q2W0
Phase 1: LAG525 3 mg/kg Q2W0
Phase 1: LAG525 5 mg/kg Q2W0
Phase 1: LAG525 10 mg/kg Q2W0
Phase 1: LAG525 15 mg/kg Q2W0
Phase 1: LAG525 240 mg Q2W0
Phase 1: LAG525 400 mg Q2W0
Phase 1: LAG525 3 mg/kg Q4W0
Phase 1: LAG525 5 mg/kg Q4W0
Phase 1: LAG525 10 mg/kg Q4W0
Phase 1: LAG525 400 mg Q4W0
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W6
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W6
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W6
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W5
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W6
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W20
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W6
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W12
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W7
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W6
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W12
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W6
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W11
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W6
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W6
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W1Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W0Not reportedNot reportedNot reportedNot reported
PDR001 dose interruption, ROW patients

Analysis denominator · Participants

GroupSource count
Phase 1: LAG525 1 mg/kg Q2W0
Phase 1: LAG525 3 mg/kg Q2W0
Phase 1: LAG525 5 mg/kg Q2W0
Phase 1: LAG525 10 mg/kg Q2W0
Phase 1: LAG525 15 mg/kg Q2W0
Phase 1: LAG525 240 mg Q2W0
Phase 1: LAG525 400 mg Q2W0
Phase 1: LAG525 3 mg/kg Q4W0
Phase 1: LAG525 5 mg/kg Q4W0
Phase 1: LAG525 10 mg/kg Q4W0
Phase 1: LAG525 400 mg Q4W0
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W6
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W6
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W6
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W5
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W6
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W20
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W6
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W12
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W7
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W6
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W12
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W6
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W11
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W6
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W6
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W4Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W1Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W2Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W1Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W6Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W2Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W2Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W1Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W2Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W3Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W3Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W1Not reportedNot reportedNot reportedNot reported
LAG525 dose reduction, Japanese patients

Analysis denominator · Participants

GroupSource count
Phase 1: LAG525 1 mg/kg Q2W4
Phase 1: LAG525 3 mg/kg Q2W0
Phase 1: LAG525 5 mg/kg Q2W0
Phase 1: LAG525 10 mg/kg Q2W0
Phase 1: LAG525 15 mg/kg Q2W0
Phase 1: LAG525 240 mg Q2W5
Phase 1: LAG525 400 mg Q2W6
Phase 1: LAG525 3 mg/kg Q4W0
Phase 1: LAG525 5 mg/kg Q4W0
Phase 1: LAG525 10 mg/kg Q4W0
Phase 1: LAG525 400 mg Q4W0
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W0
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W0
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W0
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W0
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W0
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W0
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W0
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W0
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W0
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W0
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W0
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W0
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W0
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W0
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: LAG525 1 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 240 mg Q2W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 400 mg Q2W0Not reportedNot reportedNot reportedNot reported
LAG525 dose interruption, Japanese patients

Analysis denominator · Participants

GroupSource count
Phase 1: LAG525 1 mg/kg Q2W4
Phase 1: LAG525 3 mg/kg Q2W0
Phase 1: LAG525 5 mg/kg Q2W0
Phase 1: LAG525 10 mg/kg Q2W0
Phase 1: LAG525 15 mg/kg Q2W0
Phase 1: LAG525 240 mg Q2W5
Phase 1: LAG525 400 mg Q2W6
Phase 1: LAG525 3 mg/kg Q4W0
Phase 1: LAG525 5 mg/kg Q4W0
Phase 1: LAG525 10 mg/kg Q4W0
Phase 1: LAG525 400 mg Q4W0
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W0
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W0
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W0
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W0
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W0
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W0
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W0
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W0
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W0
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W0
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W0
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W0
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W0
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W0
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: LAG525 1 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 240 mg Q2W2Not reportedNot reportedNot reportedNot reported
Phase 1: LAG525 400 mg Q2W2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        6
      6. group Id
        OG005
        value
        25
      7. group Id
        OG006
        value
        24
      8. group Id
        OG007
        value
        5
      9. group Id
        OG008
        value
        6
      10. group Id
        OG009
        value
        11
      11. group Id
        OG010
        value
        5
      12. group Id
        OG011
        value
        6
      units
      Participants
    title
    LAG525 dose reduction, ROW patients
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        2
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        6
      6. group Id
        OG005
        value
        25
      7. group Id
        OG006
        value
        24
      8. group Id
        OG007
        value
        5
      9. group Id
        OG008
        value
        6
      10. group Id
        OG009
        value
        11
      11. group Id
        OG010
        value
        5
      12. group Id
        OG011
        value
        6
      units
      Participants
    title
    LAG525 dose interruption, ROW patients
  3. categories
    1. measurements
      1. group Id
        OG011
        value
        0
      2. group Id
        OG012
        value
        0
      3. group Id
        OG013
        value
        0
      4. group Id
        OG014
        value
        0
      5. group Id
        OG015
        value
        0
      6. group Id
        OG016
        value
        0
      7. group Id
        OG017
        value
        0
      8. group Id
        OG018
        value
        0
      9. group Id
        OG019
        value
        0
      10. group Id
        OG020
        value
        0
      11. group Id
        OG021
        value
        1
      12. group Id
        OG022
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        6
      units
      Participants
    title
    PDR001 dose reduction, ROW patients
  4. categories
    1. measurements
      1. group Id
        OG011
        value
        4
      2. group Id
        OG012
        value
        1
      3. group Id
        OG013
        value
        2
      4. group Id
        OG014
        value
        1
      5. group Id
        OG015
        value
        0
      6. group Id
        OG016
        value
        6
      7. group Id
        OG017
        value
        2
      8. group Id
        OG018
        value
        2
      9. group Id
        OG019
        value
        1
      10. group Id
        OG020
        value
        2
      11. group Id
        OG021
        value
        3
      12. group Id
        OG022
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        6
      units
      Participants
    title
    PDR001 dose interruption, ROW patients
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG005
        value
        0
      3. group Id
        OG006
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        6
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
      units
      Participants
    title
    LAG525 dose reduction, Japanese patients
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG005
        value
        2
      3. group Id
        OG006
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        5
      7. group Id
        OG006
        value
        6
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
      units
      Participants
    title
    LAG525 dose interruption, Japanese patients
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      30
    7. group Id
      OG006
      value
      30
    8. group Id
      OG007
      value
      5
    9. group Id
      OG008
      value
      6
    10. group Id
      OG009
      value
      11
    11. group Id
      OG010
      value
      5
    12. group Id
      OG011
      value
      6
    units
    Participants
description
Number of participants with at least one dose reduction of LAG525, at least one dose interruption of LAG525, at least one dose reduction of PDR001 and at least one dose interruption of PDR001. Japanese patients were not treated with PDR001 and therefore the dose reductions and dose interruptions of this study drug are not applicable.
groups
  1. description
    Single-agent LAG525 1 mg/kg Q2W
    id
    OG000
    title
    Phase 1: LAG525 1 mg/kg Q2W
  2. description
    Single-agent LAG525 3 mg/kg Q2W
    id
    OG001
    title
    Phase 1: LAG525 3 mg/kg Q2W
  3. description
    Single-agent LAG525 5 mg/kg Q2W
    id
    OG002
    title
    Phase 1: LAG525 5 mg/kg Q2W
  4. description
    Single-agent LAG525 10 mg/kg Q2W
    id
    OG003
    title
    Phase 1: LAG525 10 mg/kg Q2W
  5. description
    Single-agent LAG525 15 mg/kg Q2W
    id
    OG004
    title
    Phase 1: LAG525 15 mg/kg Q2W
  6. description
    Single-agent LAG525 240 mg Q2W
    id
    OG005
    title
    Phase 1: LAG525 240 mg Q2W
  7. description
    Single-agent LAG525 400 mg Q2W
    id
    OG006
    title
    Phase 1: LAG525 400 mg Q2W
  8. description
    Single-agent LAG525 3 mg/kg Q4W
    id
    OG007
    title
    Phase 1: LAG525 3 mg/kg Q4W
  9. description
    Single-agent LAG525 5 mg/kg Q4W
    id
    OG008
    title
    Phase 1: LAG525 5 mg/kg Q4W
  10. description
    Single-agent LAG525 10 mg/kg Q4W
    id
    OG009
    title
    Phase 1: LAG525 10 mg/kg Q4W
  11. description
    Single-agent LAG525 400 mg Q4W
    id
    OG010
    title
    Phase 1: LAG525 400 mg Q4W
  12. 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 start of treatment until end of treatment, assessed up to 4.4 years.
title
Phase 1: Number of Participants With Dose Reductions and Dose Interruptions of LAG525 and PDR001
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice