NCT03581786 · OUTCOME

Number of Participants Experiencing an Adverse Event(AE)

The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer · Source last updated 2025-09-02

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 date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years

What was measured

Incidence of adverse events(AE) as assessed by CTCAE version 5.0

Groups in this outcome

Placebo Combine With Chemotherapy

Gemcitabine 1000 mg/m² IV are given on Days 1 \& 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，placebo will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and placebo for up to 2 years

TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy

Gemcitabine 1000 mg/m² IV are given on Days 1 \& 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，JS001 will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and JS001 for up to2years

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
Placebo Combine With Chemotherapy	143
TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy	146

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo Combine With Chemotherapy	143	Not reported	Not reported	Not reported	Not reported
TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy	146	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
143
group Id
OG001
value
146

denoms

counts
group Id
OG000
value
143
group Id
OG001
value
146
units
Participants

description

Incidence of adverse events(AE) as assessed by CTCAE version 5.0

groups

description
Gemcitabine 1000 mg/m² IV are given on Days 1 \& 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，placebo will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and placebo for up to 2 years
id
OG000
title
Placebo Combine With Chemotherapy
description
Gemcitabine 1000 mg/m² IV are given on Days 1 \& 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，JS001 will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and JS001 for up to2years
id
OG001
title
TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years

title

Number of Participants Experiencing an Adverse Event(AE)

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice