NCT03037385 · OUTCOME

Phase 1 and Phase 2: Number of Participants With AEs and Serious AEs (SAEs)

Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors · Source last updated 2025-05-31

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: From Cycle 1 Day 1 up to 30 days after the final dose of study drug (up to approximately 6.7 years)

What was measured

An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. A 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 or birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.

Analysis population: Safety Population included all participants who have received at least 1 dose of the study drug regardless of starting dose levels. As pre-specified in the SAP, safety data was to be analyzed and reported as per the pre-planned grouped dose level II (SAP section 3.6.5.2). Hence, per dose safety data is not presented for this study.

Groups in this outcome

Pralsetinib ≤ 300 mg QD

Participants received pralsetinib, 300 mg or less, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.

Pralsetinib 400 mg QD

Participants received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.

Pralsetinib BID Dosing Schedule

Participants received pralsetinib, 100 mg, orally, BID or 200 mg in the morning and then 100 mg in the evening, orally, until discontinuation due to toxicity, disease progression, or other reasons.

Pralsetinib All Doses

Participants received pralsetinib at varying doses at the QD and BID schedule until discontinuation due to toxicity, disease progression, or other reasons.

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
Pralsetinib ≤ 300 mg QD	37
Pralsetinib 400 mg QD	540
Pralsetinib BID Dosing Schedule	9
Pralsetinib All Doses	590

Reported measurements

AEs

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Pralsetinib ≤ 300 mg QD	37	Not reported	Not reported	Not reported	Not reported
Pralsetinib 400 mg QD	540	Not reported	Not reported	Not reported	Not reported
Pralsetinib BID Dosing Schedule	9	Not reported	Not reported	Not reported	Not reported
Pralsetinib All Doses	590	Not reported	Not reported	Not reported	Not reported

SAEs

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Pralsetinib ≤ 300 mg QD	26	Not reported	Not reported	Not reported	Not reported
Pralsetinib 400 mg QD	381	Not reported	Not reported	Not reported	Not reported
Pralsetinib BID Dosing Schedule	7	Not reported	Not reported	Not reported	Not reported
Pralsetinib All Doses	416	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
37
group Id
OG001
value
540
group Id
OG002
value
9
group Id
OG003
value
590
title
AEs
categories
measurements
group Id
OG000
value
26
group Id
OG001
value
381
group Id
OG002
value
7
group Id
OG003
value
416
title
SAEs

denoms

counts
group Id
OG000
value
37
group Id
OG001
value
540
group Id
OG002
value
9
group Id
OG003
value
590
units
Participants

description

groups

description
Participants received pralsetinib, 300 mg or less, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
id
OG000
title
Pralsetinib ≤ 300 mg QD
description
Participants received pralsetinib, 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
id
OG001
title
Pralsetinib 400 mg QD
description
Participants received pralsetinib, 100 mg, orally, BID or 200 mg in the morning and then 100 mg in the evening, orally, until discontinuation due to toxicity, disease progression, or other reasons.
id
OG002
title
Pralsetinib BID Dosing Schedule
description
Participants received pralsetinib at varying doses at the QD and BID schedule until discontinuation due to toxicity, disease progression, or other reasons.
id
OG003
title
Pralsetinib All Doses

param Type

NUMBER

population Description

Safety Population included all participants who have received at least 1 dose of the study drug regardless of starting dose levels. As pre-specified in the SAP, safety data was to be analyzed and reported as per the pre-planned grouped dose level II (SAP section 3.6.5.2). Hence, per dose safety data is not presented for this study.

reporting Status

POSTED

time Frame

From Cycle 1 Day 1 up to 30 days after the final dose of study drug (up to approximately 6.7 years)

title

Phase 1 and Phase 2: Number of Participants With AEs and Serious AEs (SAEs)

type

PRIMARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice