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NCT04222972 · OUTCOME

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2026-03-05

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 approximately 50 months

What was measured

An AE is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.

Analysis population: Safety-evaluable population included all participants who receive any amount of any study drug.

Groups in this outcome

Arm A: Treatment Period- SOC

Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.

Arm B: Treatment Period- Pralsetinib

Participants received pralsetinib, 400 mg, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).

Arm C: Crossover Period- Pralsetinib

Participants with confirmed PD as confirmed by blinded independent central review (BICR) in Arm A crossed over to receive pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity or death, whichever occurred first (cycle length=21 days).

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

Analysis denominator · Participants

GroupSource count
Arm A: Treatment Period- SOC104
Arm B: Treatment Period- Pralsetinib108
Arm C: Crossover Period- Pralsetinib38

Reported measurements

AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Treatment Period- SOC104Not reportedNot reportedNot reportedNot reported
Arm B: Treatment Period- Pralsetinib108Not reportedNot reportedNot reportedNot reported
Arm C: Crossover Period- Pralsetinib38Not reportedNot reportedNot reportedNot reported
SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Treatment Period- SOC38Not reportedNot reportedNot reportedNot reported
Arm B: Treatment Period- Pralsetinib67Not reportedNot reportedNot reportedNot reported
Arm C: Crossover Period- Pralsetinib22Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        104
      2. group Id
        OG001
        value
        108
      3. group Id
        OG002
        value
        38
    title
    AEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        67
      3. group Id
        OG002
        value
        22
    title
    SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      104
    2. group Id
      OG001
      value
      108
    3. group Id
      OG002
      value
      38
    units
    Participants
description
An AE is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
groups
  1. description
    Participants received platinum-containing anticancer treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating investigator based on NSCLC histology. Participants with NSCLC of non-squamous histology received carboplatin + pemetrexed or cisplatin + pemetrexed or pembrolizumab + carboplatin + pemetrexed or pembrolizumab + cisplatin + pemetrexed. Participants with NSCLC of squamous histology received carboplatin or cisplatin + gemcitabine or carboplatin + paclitaxel/nab-paclitaxel + pembrolizumab until PD or for up to a maximum of 2 years.
    id
    OG000
    title
    Arm A: Treatment Period- SOC
  2. description
    Participants received pralsetinib, 400 mg, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity, non-compliance, withdrawal of consent, closure of the study by the sponsor, or death, whichever occurred first (cycle length=21 days).
    id
    OG001
    title
    Arm B: Treatment Period- Pralsetinib
  3. description
    Participants with confirmed PD as confirmed by blinded independent central review (BICR) in Arm A crossed over to receive pralsetinib, 400 mg, orally, QD on Day 1 of each cycle until PD, PTAP, pralsetinib was no longer available, unacceptable toxicity or death, whichever occurred first (cycle length=21 days).
    id
    OG002
    title
    Arm C: Crossover Period- Pralsetinib
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety-evaluable population included all participants who receive any amount of any study drug.
reporting Status
POSTED
time Frame
Up to approximately 50 months
title
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-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice