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 — 196 AEs, 18 serious
Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-04-12 (study day 3); relationship: N; serious criteria: hospitalization
Grade 3 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-08-04 (study day 60); relationship: not assessed; serious criteria: hospitalization
Grade 4 Decreased appetite — outcome: UNKNOWN; onset 2022-07-26 (study day 14); relationship: not assessed; serious criteria: life-threatening
Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2024-01-23 (study day 539); relationship: not assessed; serious criteria: life-threatening
Grade 4 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-02-26 (study day 189); relationship: Y; serious criteria: life-threatening
Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-12-22 (study day 475); relationship: not assessed; serious criteria: life-threatening
Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-11-10 (study day 42); relationship: N; serious criteria: hospitalization
Grade 3 Adrenal insufficiency — outcome: RECOVERED/RESOLVED; onset 2023-03-02 (study day 85); relationship: not assessed; serious criteria: hospitalization
QA findings (2 open)
MISSED REQUIRED EFFICACY ASSESSMENT: Two consecutive scheduled tumour assessments missed (subject SITE007-0077, 2023-03-11)
OTHER: Pharmacist did not document drug accountability per SOP (subject SITE007-0122, 2024-01-01)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE007-0147, 2023-12-22)
LATE ASSESSMENT: ECOG performance status assessment missed (subject SITE007-0250, 2023-03-07)
OTHER: ePRO not completed at scheduled visit (subject SITE007-0250, 2023-04-03)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE007-0283, 2024-01-26)
PROHIBITED CONCOMITANT MEDICATION: Subject received immunosuppressive therapy during treatment (subject SITE007-0335, 2024-11-14)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE007-0338, 2023-04-16)
LATE ASSESSMENT: Safety assessment delayed (subject SITE007-0378, 2023-08-03)
OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE007-0397, 2023-08-13)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE007-0397, 2024-06-28)
OTHER: Pharmacist did not document drug accountability per SOP (subject SITE007-0399, 2023-10-05)
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