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SITE011 (ITA)

KRI 0.45
ITA · PI Dr. Jansen · activated
Patients
30
Active
0
Serious AEs
15
Open QA
3
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)

SITE011-0007 › completed SITE011-0011 › completed SITE011-0035 › completed SITE011-0038 › completed SITE011-0049 › completed SITE011-0075 › completed SITE011-0083 › completed SITE011-0107 › completed SITE011-0114 › withdrawn SITE011-0115 › completed SITE011-0146 › completed SITE011-0175 › completed SITE011-0176 › completed SITE011-0177 › completed SITE011-0204 › completed SITE011-0218 › completed SITE011-0239 › completed SITE011-0261 › withdrawn SITE011-0281 › completed SITE011-0289 › completed SITE011-0297 › completed SITE011-0299 › completed SITE011-0310 › completed SITE011-0316 › completed SITE011-0332 › completed SITE011-0347 › completed SITE011-0352 › completed SITE011-0357 › completed SITE011-0367 › completed SITE011-0410 › completed

Safety — 207 AEs, 15 serious

serious SITE011-0107

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-07-29 (study day 12); relationship: not assessed; serious criteria: hospitalization

serious SITE011-0107

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-08-20 (study day 34); relationship: N; serious criteria: life-threatening

serious SITE011-0107

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-09-14 (study day 59); relationship: Y; serious criteria: life-threatening

serious SITE011-0175

Grade 3 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-10-05 (study day 363); relationship: N; serious criteria: hospitalization

serious SITE011-0176

Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-05-18 (study day 222); relationship: not assessed; serious criteria: hospitalization

serious SITE011-0239

Grade 4 Pneumonitis — outcome: RECOVERED/RESOLVED; onset 2023-01-31 (study day 44); relationship: not assessed; serious criteria: life-threatening

serious SITE011-0239

Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-03-09 (study day 81); relationship: not assessed; serious criteria: hospitalization

serious SITE011-0261

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-02-24 (study day 409); relationship: not assessed; serious criteria: life-threatening

QA findings (3 open)

open major

MISSED REQUIRED EFFICACY ASSESSMENT: Three consecutive scheduled tumour assessments missed (subject SITE011-0035, 2023-01-16)

resolved minor

LATE ASSESSMENT: Tumour assessment performed >7 days late (subject SITE011-0038, 2022-09-23)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE011-0038, 2022-12-17)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE011-0038, 2023-04-22)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE011-0075, 2022-12-16)

open major

DOSE MODIFICATION ERROR: Treatment continued through Grade 3 AE without dose modification per protocol (subject SITE011-0114, 2022-09-09)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE011-0115, 2023-06-24)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE011-0115, 2023-07-12)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE011-0115, 2024-05-21)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE011-0175, 2023-01-10)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE011-0204, 2023-02-26)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE011-0239, 2023-03-12)

Visits & payments

Nothing scheduled.

☾ Luna participants

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