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SITE005 (FRA)

KRI 0.4
FRA · PI Dr. Muller · activated
Patients
30
Active
0
Serious AEs
20
Open QA
2
Aged queries
0
Luna users
0

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 completed · contract executed · 330000 USD

Patients (30)

SITE005-0001 › completed SITE005-0014 › withdrawn SITE005-0020 › completed SITE005-0045 › completed SITE005-0047 › withdrawn SITE005-0074 › completed SITE005-0090 › withdrawn SITE005-0104 › withdrawn SITE005-0131 › completed SITE005-0139 › completed SITE005-0150 › completed SITE005-0212 › completed SITE005-0219 › completed SITE005-0240 › completed SITE005-0246 › completed SITE005-0262 › completed SITE005-0273 › completed SITE005-0287 › completed SITE005-0305 › completed SITE005-0307 › withdrawn SITE005-0317 › completed SITE005-0321 › completed SITE005-0324 › completed SITE005-0327 › completed SITE005-0342 › completed SITE005-0355 › completed SITE005-0365 › completed SITE005-0383 › completed SITE005-0396 › completed SITE005-0400 › completed

Safety — 183 AEs, 20 serious

serious SITE005-0014

Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-05-28 (study day 72); relationship: N; serious criteria: life-threatening

serious SITE005-0014

Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-06-05 (study day 80); relationship: not assessed; serious criteria: life-threatening

serious SITE005-0047

Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-06-06 (study day 33); relationship: N; serious criteria: hospitalization

serious SITE005-0047

Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-07-05 (study day 62); relationship: N; serious criteria: hospitalization

serious SITE005-0047

Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-12-17 (study day 592); relationship: not assessed; serious criteria: hospitalization

serious SITE005-0104

Grade 3 Pruritus — outcome: RECOVERED/RESOLVED; onset 2022-08-24 (study day 40); relationship: not assessed; serious criteria: hospitalization

serious SITE005-0104

Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-03-26 (study day 620); relationship: N; serious criteria: hospitalization

serious SITE005-0150

Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-09-17 (study day 11); relationship: N; serious criteria: hospitalization

QA findings (2 open)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE005-0001, 2022-09-04)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE005-0001, 2023-03-17)

resolved minor

LATE ASSESSMENT: ECOG performance status assessment missed (subject SITE005-0020, 2023-03-26)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE005-0074, 2023-04-07)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE005-0074, 2023-09-19)

open major

MISSED REQUIRED EFFICACY ASSESSMENT: Two consecutive scheduled tumour assessments missed (subject SITE005-0090, 2023-09-20)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE005-0090, 2023-11-07)

resolved minor

OTHER: ePRO not completed at scheduled visit (subject SITE005-0131, 2022-11-22)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE005-0212, 2023-03-01)

resolved minor

MISSED ROUTINE ASSESSMENT: Chemistry panel incomplete (subject SITE005-0212, 2023-09-01)

open major

MISSED REQUIRED EFFICACY ASSESSMENT: Three consecutive scheduled tumour assessments missed (subject SITE005-0212, 2023-09-27)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE005-0212, 2023-12-06)

Visits & payments

Nothing scheduled.

☾ Luna participants

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