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SITE002 (USA)

KRI 0.48
USA · PI Dr. Nolan · activated
Patients
30
Active
0
Serious AEs
18
Open QA
3
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)

SITE002-0018 › completed SITE002-0025 › completed SITE002-0054 › completed SITE002-0062 › withdrawn SITE002-0069 › completed SITE002-0071 › completed SITE002-0132 › completed SITE002-0153 › completed SITE002-0171 › completed SITE002-0180 › completed SITE002-0187 › completed SITE002-0188 › completed SITE002-0193 › completed SITE002-0202 › completed SITE002-0209 › completed SITE002-0214 › completed SITE002-0235 › completed SITE002-0237 › completed SITE002-0241 › completed SITE002-0244 › completed SITE002-0270 › completed SITE002-0295 › completed SITE002-0328 › completed SITE002-0331 › completed SITE002-0341 › completed SITE002-0370 › completed SITE002-0401 › completed SITE002-0409 › completed SITE002-0412 › withdrawn SITE002-0416 › completed

Safety — 183 AEs, 18 serious

serious SITE002-0025

Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-07-27 (study day 119); relationship: N; serious criteria: hospitalization

serious SITE002-0062

Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-06-22 (study day 30); relationship: not assessed; serious criteria: life-threatening

serious SITE002-0171

Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-12-03 (study day 65); relationship: N; serious criteria: hospitalization

serious SITE002-0188

Grade 4 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-04-11 (study day 167); relationship: N; serious criteria: life-threatening

serious SITE002-0193

Grade 4 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2024-07-01 (study day 608); relationship: not assessed; serious criteria: life-threatening

serious SITE002-0237

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-01-20 (study day 399); relationship: not assessed; serious criteria: life-threatening

serious SITE002-0241

Grade 4 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-10-16 (study day 299); relationship: N; serious criteria: life-threatening

serious SITE002-0241

Grade 3 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-06-10 (study day 537); relationship: not assessed; serious criteria: hospitalization

QA findings (3 open)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE002-0025, 2023-02-18)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE002-0054, 2022-07-13)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE002-0054, 2023-04-29)

open major

OTHER: Informed consent form not signed prior to randomisation (subject SITE002-0062, 2022-09-14)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE002-0062, 2022-10-10)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE002-0071, 2022-08-05)

resolved minor

LATE ASSESSMENT: ECOG performance status assessment missed (subject SITE002-0071, 2022-11-22)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE002-0132, 2023-10-18)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE002-0188, 2023-10-08)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE002-0202, 2022-12-09)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE002-0209, 2023-05-30)

resolved minor

LATE ASSESSMENT: Tumour assessment performed >7 days late (subject SITE002-0209, 2024-02-17)

Visits & payments

Nothing scheduled.

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