Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03409614 · OUTCOME

Part 2: Number of Participants With Serious TEAEs

Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer · Source last updated 2026-05-18

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 drug in Part 2, up to approximately 69 months

What was measured

Serious TEAEs were defined as medically significant but not immediately life-threatening AEs that developed or worsened during the on-treatment period and any treatment-related AEs that occurred during the post-treatment period but prior to start of another anti-cancer systemic therapy.

Analysis population: Randomized and treated Part 2 participants only

Groups in this outcome

Part 2: Cemiplimab + Chemotherapy

Participants received cemiplimab plus platinum-based doublet chemotherapy

Part 2: Placebo + Chemotherapy

Placebo matching cemiplimab plus platinum-based doublet chemotherapy

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

Analysis denominator · Participants

GroupSource count
Part 2: Cemiplimab + Chemotherapy312
Part 2: Placebo + Chemotherapy153

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: Cemiplimab + Chemotherapy95Not reportedNot reportedNot reportedNot reported
Part 2: Placebo + Chemotherapy37Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        37
denoms
  1. counts
    1. group Id
      OG000
      value
      312
    2. group Id
      OG001
      value
      153
    units
    Participants
description
Serious TEAEs were defined as medically significant but not immediately life-threatening AEs that developed or worsened during the on-treatment period and any treatment-related AEs that occurred during the post-treatment period but prior to start of another anti-cancer systemic therapy.
groups
  1. description
    Participants received cemiplimab plus platinum-based doublet chemotherapy
    id
    OG000
    title
    Part 2: Cemiplimab + Chemotherapy
  2. description
    Placebo matching cemiplimab plus platinum-based doublet chemotherapy
    id
    OG001
    title
    Part 2: Placebo + Chemotherapy
param Type
COUNT_OF_PARTICIPANTS
population Description
Randomized and treated Part 2 participants only
reporting Status
POSTED
time Frame
From first dose of study drug in Part 2, up to approximately 69 months
title
Part 2: Number of Participants With Serious TEAEs
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice