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SITE009 (AUS)

KRI 0.84
AUS · PI Dr. Novak · activated
Patients
30
Active
0
Serious AEs
14
Open QA
7
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)

SITE009-0016 › withdrawn SITE009-0036 › completed SITE009-0040 › completed SITE009-0055 › withdrawn SITE009-0070 › withdrawn SITE009-0073 › completed SITE009-0081 › completed SITE009-0089 › completed SITE009-0091 › completed SITE009-0098 › completed SITE009-0120 › completed SITE009-0143 › completed SITE009-0145 › withdrawn SITE009-0162 › completed SITE009-0168 › completed SITE009-0182 › completed SITE009-0191 › completed SITE009-0255 › completed SITE009-0259 › completed SITE009-0268 › completed SITE009-0351 › completed SITE009-0353 › completed SITE009-0354 › completed SITE009-0373 › completed SITE009-0413 › completed SITE009-0414 › completed SITE009-0415 › completed SITE009-0428 › completed SITE009-0439 › completed SITE009-0442 › completed

Safety — 177 AEs, 14 serious

serious SITE009-0016

Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-10-09 (study day 204); relationship: not assessed; serious criteria: life-threatening

serious SITE009-0040

Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-05-25 (study day 29); relationship: not assessed; serious criteria: hospitalization

serious SITE009-0070

Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-12-27 (study day 574); relationship: not assessed; serious criteria: hospitalization

serious SITE009-0089

Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-03-31 (study day 645); relationship: not assessed; serious criteria: life-threatening

serious SITE009-0089

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-07-06 (study day 742); relationship: not assessed; serious criteria: hospitalization

serious SITE009-0091

Grade 3 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2024-02-27 (study day 611); relationship: not assessed; serious criteria: hospitalization

serious SITE009-0351

Grade 4 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-12-26 (study day 242); relationship: not assessed; serious criteria: life-threatening

serious SITE009-0353

Grade 3 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-10-22 (study day 174); relationship: Y; serious criteria: hospitalization

QA findings (7 open)

resolved minor

OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE009-0016, 2022-05-12)

open major

OTHER: Randomisation stratum mis-assigned (subject SITE009-0036, 2022-12-01)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE009-0070, 2023-07-22)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE009-0089, 2025-01-25)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE009-0145, 2022-08-30)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE009-0168, 2022-10-23)

resolved minor

OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE009-0168, 2024-05-02)

resolved minor

LATE ASSESSMENT: Safety assessment delayed (subject SITE009-0182, 2022-11-12)

open major

MISSED REQUIRED EFFICACY ASSESSMENT: Two consecutive scheduled tumour assessments missed (subject SITE009-0182, 2025-01-05)

open major

PROHIBITED CONCOMITANT MEDICATION: Subject received live attenuated vaccine during treatment period (subject SITE009-0268, 2023-02-06)

open major

DOSE MODIFICATION ERROR: Dose held longer than protocol-permitted 6 weeks (subject SITE009-0268, 2023-05-07)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE009-0268, 2023-05-09)

Visits & payments

on_site 2026-09-01 risk

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