SITE012 (BRA)

Sites / BRA

SITE012 (BRA)

BRA · PI Dr. Kowalski · activated

KRI 0.384

Patients

26

Active

21

Serious AEs

7

Open QA

2

Aged queries

1

Luna users

0

Studies & contracts

1

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

26

SITE012-0006

enrolled

SITE012-0012

enrolled

SITE012-0015

completed

SITE012-0019

enrolled

SITE012-0053

completed

SITE012-0061

enrolled

SITE012-0076

enrolled

SITE012-0093

enrolled

SITE012-0096

enrolled

SITE012-0100

completed

SITE012-0110

enrolled

SITE012-0149

enrolled

SITE012-0164

enrolled

SITE012-0169

enrolled

SITE012-0172

enrolled

SITE012-0195

enrolled

SITE012-0203

enrolled

SITE012-0213

completed

SITE012-0252

enrolled

SITE012-0264

enrolled

SITE012-0266

enrolled

SITE012-0272

enrolled

SITE012-0277

completed

SITE012-0282

enrolled

SITE012-0306

enrolled

SITE012-0312

enrolled

Safety

81 AEs · 7 serious

Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-02-28 (study day 114); relationship: not assessed; serious criteria: hospitalization

serious SITE012-0203

Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-02-13 (study day 336); relationship: not assessed; serious criteria: hospitalization

serious SITE012-0012

Grade 3 Asthenia — outcome: UNKNOWN; onset 2022-12-31 (study day 60); relationship: not assessed; serious criteria: hospitalization

serious SITE012-0195

Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-07-27 (study day 22); relationship: not assessed; serious criteria: hospitalization

serious SITE012-0100

Grade 4 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-06-20 (study day 94); relationship: NOT RELATED; serious criteria: life-threatening

serious SITE012-0015

Grade 3 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-05-14 (study day 2); relationship: NOT RELATED; serious criteria: hospitalization

serious SITE012-0053

Grade 3 Pneumonitis — outcome: RECOVERED/RESOLVED; onset 2022-04-12 (study day 39); relationship: not assessed; serious criteria: hospitalization

serious SITE012-0006

QA findings

2 open

LATE ASSESSMENT: Tumour assessment performed >7 days late (subject SITE012-0169, 2026-08-30)

resolved minor

PROHIBITED CONCOMITANT MEDICATION: Subject received systemic corticosteroid > 10 mg/d prednisone equivalent (subject SITE012-0277, 2026-08-17)

open major

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE012-0093, 2026-08-04)

resolved minor

LATE ASSESSMENT: Safety assessment delayed (subject SITE012-0110, 2026-07-05)

resolved minor

PROHIBITED CONCOMITANT MEDICATION: Subject received live attenuated vaccine during treatment period (subject SITE012-0213, 2026-07-03)

open major

MISSED ROUTINE ASSESSMENT: Vital signs not recorded at scheduled visit (subject SITE012-0169, 2026-04-19)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE012-0015, 2026-02-23)

resolved minor

MISSED ROUTINE ASSESSMENT: Chemistry panel incomplete (subject SITE012-0053, 2025-12-15)

resolved minor

MISSED ROUTINE ASSESSMENT: Haematology missed at scheduled visit (subject SITE012-0053, 2025-12-10)

resolved minor

Visits & payments

0

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

Luna participants

0

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

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