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SITE001 (USA)

KRI 0.39
USA · PI Dr. Reyes · activated
Patients
30
Active
0
Serious AEs
19
Open QA
2
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)

SITE001-0026 › completed SITE001-0029 › completed SITE001-0034 › completed SITE001-0057 › completed SITE001-0066 › completed SITE001-0068 › completed SITE001-0078 › completed SITE001-0092 › completed SITE001-0099 › completed SITE001-0119 › completed SITE001-0134 › completed SITE001-0140 › completed SITE001-0157 › completed SITE001-0165 › completed SITE001-0208 › completed SITE001-0216 › completed SITE001-0251 › completed SITE001-0263 › completed SITE001-0267 › completed SITE001-0271 › completed SITE001-0303 › completed SITE001-0330 › completed SITE001-0334 › withdrawn SITE001-0346 › completed SITE001-0349 › withdrawn SITE001-0366 › completed SITE001-0376 › completed SITE001-0423 › completed SITE001-0427 › completed SITE001-0436 › completed

Safety — 170 AEs, 19 serious

serious SITE001-0026

Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-04-11 (study day 12); relationship: not assessed; serious criteria: hospitalization

serious SITE001-0057

Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-18 (study day 250); relationship: N; serious criteria: hospitalization

serious SITE001-0068

Grade 4 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-10-03 (study day 129); relationship: N; serious criteria: life-threatening

serious SITE001-0092

Grade 3 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-08-02 (study day 35); relationship: not assessed; serious criteria: hospitalization

serious SITE001-0092

Grade 4 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-10-21 (study day 115); relationship: not assessed; serious criteria: life-threatening

serious SITE001-0099

Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-11-24 (study day 508); relationship: not assessed; serious criteria: hospitalization

serious SITE001-0119

Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-03-09 (study day 221); relationship: N; serious criteria: life-threatening

serious SITE001-0157

Grade 3 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-12-03 (study day 443); relationship: not assessed; serious criteria: hospitalization

QA findings (2 open)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE001-0029, 2022-05-15)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE001-0034, 2023-04-04)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE001-0034, 2023-07-19)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE001-0034, 2023-10-21)

resolved minor

OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE001-0057, 2022-10-04)

resolved minor

OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE001-0066, 2022-08-19)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE001-0066, 2022-11-12)

resolved minor

MISSED ROUTINE ASSESSMENT: Chemistry panel incomplete (subject SITE001-0066, 2024-01-24)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE001-0068, 2022-11-02)

resolved minor

LATE ASSESSMENT: Safety assessment delayed (subject SITE001-0068, 2022-11-14)

resolved minor

MISSED ROUTINE ASSESSMENT: Vital signs not recorded at scheduled visit (subject SITE001-0068, 2023-04-24)

open major

DOSE MODIFICATION ERROR: Dose held longer than protocol-permitted 6 weeks (subject SITE001-0078, 2024-08-11)

Visits & payments

Nothing scheduled.

☾ Luna participants

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