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)
Safety — 171 AEs, 23 serious
Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-10-16 (study day 593); relationship: not assessed; serious criteria: life-threatening
Grade 3 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2022-05-07 (study day 40); relationship: N; serious criteria: hospitalization
Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-05-22 (study day 55); relationship: Y; serious criteria: hospitalization
Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-05-27 (study day 60); relationship: not assessed; serious criteria: life-threatening
Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-05-18 (study day 14); relationship: not assessed; serious criteria: hospitalization
Grade 4 Adrenal insufficiency — outcome: RECOVERED/RESOLVED; onset 2022-07-01 (study day 47); relationship: not assessed; serious criteria: life-threatening
Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-10-29 (study day 529); relationship: N; serious criteria: hospitalization
Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-08-26 (study day 94); relationship: not assessed; serious criteria: hospitalization
QA findings (4 open)
MISSED ROUTINE ASSESSMENT: Vital signs not recorded at scheduled visit (subject SITE006-0024, 2022-04-09)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE006-0060, 2023-10-18)
OTHER: ePRO not completed at scheduled visit (subject SITE006-0105, 2022-08-11)
OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE006-0105, 2022-10-28)
MISSED ROUTINE ASSESSMENT: Vital signs not recorded at scheduled visit (subject SITE006-0178, 2022-11-12)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE006-0178, 2022-12-10)
MISSED REQUIRED EFFICACY ASSESSMENT: Three consecutive scheduled tumour assessments missed (subject SITE006-0211, 2022-11-25)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE006-0258, 2024-01-16)
MISSED ROUTINE ASSESSMENT: Vital signs not recorded at scheduled visit (subject SITE006-0314, 2023-10-21)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE006-0314, 2025-01-11)
PROHIBITED CONCOMITANT MEDICATION: Subject received live attenuated vaccine during treatment period (subject SITE006-0333, 2023-07-26)
LATE ASSESSMENT: Safety assessment delayed (subject SITE006-0364, 2023-05-30)
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