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SITE003 (CAN)

KRI 0.37
CAN · PI Dr. Okafor · activated
Patients
30
Active
0
Serious AEs
17
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)

SITE003-0008 › completed SITE003-0013 › completed SITE003-0043 › completed SITE003-0051 › withdrawn SITE003-0106 › completed SITE003-0109 › completed SITE003-0112 › completed SITE003-0121 › completed SITE003-0130 › completed SITE003-0154 › completed SITE003-0158 › completed SITE003-0163 › completed SITE003-0179 › completed SITE003-0210 › completed SITE003-0222 › completed SITE003-0224 › completed SITE003-0225 › completed SITE003-0242 › completed SITE003-0249 › completed SITE003-0291 › completed SITE003-0293 › completed SITE003-0301 › completed SITE003-0329 › completed SITE003-0368 › completed SITE003-0384 › completed SITE003-0393 › completed SITE003-0403 › completed SITE003-0406 › withdrawn SITE003-0407 › completed SITE003-0434 › completed

Safety — 198 AEs, 17 serious

serious SITE003-0013

Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-01-04 (study day 296); relationship: not assessed; serious criteria: hospitalization

serious SITE003-0154

Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-04-23 (study day 224); relationship: N; serious criteria: life-threatening

serious SITE003-0154

Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-11-01 (study day 416); relationship: N; serious criteria: hospitalization

serious SITE003-0154

Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2024-03-18 (study day 554); relationship: N; serious criteria: life-threatening

serious SITE003-0210

Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-03-24 (study day 133); relationship: N; serious criteria: life-threatening

serious SITE003-0222

Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-12-13 (study day 15); relationship: not assessed; serious criteria: life-threatening

serious SITE003-0291

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-01-03 (study day 315); relationship: not assessed; serious criteria: hospitalization

serious SITE003-0291

Grade 4 Constipation — outcome: RECOVERED/RESOLVED; onset 2024-09-18 (study day 574); relationship: not assessed; serious criteria: life-threatening

QA findings (2 open)

resolved minor

MISSED ROUTINE ASSESSMENT: Haematology missed at scheduled visit (subject SITE003-0112, 2023-04-29)

open major

ENROLLMENT/ELIGIBILITY CRITERIA NOT MET: Baseline PD-L1 TPS < 50% — eligibility criterion violated (subject SITE003-0130, 2022-11-21)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE003-0130, 2023-01-31)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE003-0130, 2023-01-31)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE003-0130, 2023-12-06)

open major

OTHER: Wrong study drug dispensed at site (corrected next cycle) (subject SITE003-0210, 2024-01-07)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE003-0222, 2023-01-01)

resolved minor

MISSED ROUTINE ASSESSMENT: Chemistry panel incomplete (subject SITE003-0222, 2023-06-03)

resolved minor

LATE ASSESSMENT: ECOG performance status assessment missed (subject SITE003-0222, 2023-07-06)

resolved minor

LATE ASSESSMENT: Tumour assessment performed >7 days late (subject SITE003-0222, 2023-11-05)

resolved minor

MISSED ROUTINE ASSESSMENT: Chemistry panel incomplete (subject SITE003-0222, 2024-01-21)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE003-0224, 2024-04-04)

Visits & payments

Nothing scheduled.

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