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 — 188 AEs, 17 serious
Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-04-27 (study day 56); relationship: not assessed; serious criteria: life-threatening
Grade 4 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-09-05 (study day 162); relationship: not assessed; serious criteria: life-threatening
Grade 3 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-11-08 (study day 226); relationship: Y; serious criteria: hospitalization
Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-06-12 (study day 54); relationship: not assessed; serious criteria: hospitalization
Grade 4 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-09-26 (study day 114); relationship: not assessed; serious criteria: life-threatening
Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-01-09 (study day 208); relationship: not assessed; serious criteria: hospitalization
Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-09 (study day 359); relationship: not assessed; serious criteria: hospitalization
Grade 4 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2024-03-04 (study day 627); relationship: N; serious criteria: life-threatening
QA findings (6 open)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE015-0009, 2022-08-30)
OTHER: Randomisation stratum mis-assigned (subject SITE015-0009, 2022-09-22)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE015-0102, 2022-08-19)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE015-0117, 2022-09-08)
MISSED ROUTINE ASSESSMENT: Vital signs not recorded at scheduled visit (subject SITE015-0117, 2023-03-01)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE015-0117, 2023-06-20)
MISSED ROUTINE ASSESSMENT: Chemistry panel incomplete (subject SITE015-0148, 2023-04-28)
OTHER: Pharmacist did not document drug accountability per SOP (subject SITE015-0186, 2022-11-13)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE015-0186, 2022-12-13)
MISSED REQUIRED EFFICACY ASSESSMENT: Two consecutive scheduled tumour assessments missed (subject SITE015-0186, 2023-05-05)
PROHIBITED CONCOMITANT MEDICATION: Subject received live attenuated vaccine during treatment period (subject SITE015-0186, 2023-05-23)
MISSED ROUTINE ASSESSMENT: Haematology missed at scheduled visit (subject SITE015-0198, 2023-03-09)
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