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 — 204 AEs, 13 serious
Grade 3 Pneumonitis — outcome: RECOVERED/RESOLVED; onset 2022-04-12 (study day 39); relationship: not assessed; serious criteria: hospitalization
Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-03 (study day 761); relationship: not assessed; serious criteria: hospitalization
Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-02-13 (study day 336); relationship: not assessed; serious criteria: hospitalization
Grade 4 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2022-06-20 (study day 94); relationship: N; serious criteria: life-threatening
Grade 3 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-05-14 (study day 2); relationship: N; serious criteria: hospitalization
Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-07-27 (study day 22); relationship: not assessed; serious criteria: hospitalization
Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-11-13 (study day 848); relationship: not assessed; serious criteria: hospitalization
Grade 3 Asthenia — outcome: UNKNOWN; onset 2022-12-31 (study day 60); relationship: not assessed; serious criteria: hospitalization
QA findings (3 open)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE012-0015, 2022-08-19)
MISSED ROUTINE ASSESSMENT: Haematology missed at scheduled visit (subject SITE012-0053, 2022-06-05)
MISSED ROUTINE ASSESSMENT: Chemistry panel incomplete (subject SITE012-0053, 2022-06-10)
OTHER: ePRO not completed at scheduled visit (subject SITE012-0061, 2023-10-14)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE012-0093, 2023-01-28)
DOSE MODIFICATION ERROR: Dose reduction below protocol-permitted minimum (subject SITE012-0093, 2023-07-24)
MISSED ROUTINE ASSESSMENT: Haematology missed at scheduled visit (subject SITE012-0096, 2024-06-26)
LATE ASSESSMENT: Safety assessment delayed (subject SITE012-0110, 2022-12-29)
MISSED ROUTINE ASSESSMENT: Vital signs not recorded at scheduled visit (subject SITE012-0169, 2022-10-13)
LATE ASSESSMENT: Tumour assessment performed >7 days late (subject SITE012-0169, 2023-02-23)
PROHIBITED CONCOMITANT MEDICATION: Subject received live attenuated vaccine during treatment period (subject SITE012-0213, 2022-12-27)
ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE012-0252, 2023-05-19)
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