Sites / DEU

SITE004 (DEU)

DEU · PI Dr. Tanaka · activated

KRI 0.139

Patients

Active

Serious AEs

Open QA

Aged queries

Luna users

Studies & contracts

A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer

Phase III · study active · 330000 USD

executed

Patients

SITE004-0017

SITE004-0031

SITE004-0041

SITE004-0080

SITE004-0084

SITE004-0088

SITE004-0097

SITE004-0128

SITE004-0144

SITE004-0156

SITE004-0166

SITE004-0167

SITE004-0194

SITE004-0220

SITE004-0229

SITE004-0243

SITE004-0265

SITE004-0286

SITE004-0288

SITE004-0304

SITE004-0309

Safety

77 AEs · 7 serious

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-02-04 (study day 142); relationship: not assessed; serious criteria: hospitalization

serious SITE004-0156

Grade 3 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-01-22 (study day 129); relationship: not assessed; serious criteria: hospitalization

serious SITE004-0156

Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-11-04 (study day 3); relationship: not assessed; serious criteria: hospitalization

serious SITE004-0194

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-01 (study day 54); relationship: not assessed; serious criteria: life-threatening

serious SITE004-0128

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-28 (study day 128); relationship: not assessed; serious criteria: life-threatening

serious SITE004-0017

Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-07-23 (study day 30); relationship: not assessed; serious criteria: life-threatening

serious SITE004-0088

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-04-30 (study day 24); relationship: NOT RELATED; serious criteria: life-threatening

serious SITE004-0031

QA findings

1 open

MISSED REQUIRED EFFICACY ASSESSMENT: Three consecutive scheduled tumour assessments missed (subject SITE004-0041, 2025-11-12)

open major

Visits & payments

Nothing scheduled. Re-score risk to let the pipeline propose a visit.

Luna participants

No Luna participants here yet. Participants join once invited by the site.

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