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SITE010 (ESP)

KRI 0.4
ESP · PI Dr. Silva · activated
Patients
30
Active
0
Serious AEs
10
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)

SITE010-0039 › completed SITE010-0046 › withdrawn SITE010-0094 › completed SITE010-0095 › completed SITE010-0101 › completed SITE010-0111 › completed SITE010-0127 › completed SITE010-0152 › completed SITE010-0181 › completed SITE010-0190 › completed SITE010-0205 › completed SITE010-0206 › completed SITE010-0207 › completed SITE010-0221 › completed SITE010-0238 › completed SITE010-0248 › completed SITE010-0275 › completed SITE010-0279 › completed SITE010-0294 › completed SITE010-0296 › completed SITE010-0318 › completed SITE010-0319 › completed SITE010-0377 › withdrawn SITE010-0381 › completed SITE010-0395 › completed SITE010-0411 › withdrawn SITE010-0429 › completed SITE010-0441 › completed SITE010-0446 › completed SITE010-0449 › completed

Safety — 194 AEs, 10 serious

serious SITE010-0095

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-09-03 (study day 64); relationship: N; serious criteria: life-threatening

serious SITE010-0181

Grade 4 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-05-10 (study day 577); relationship: Y; serious criteria: life-threatening

serious SITE010-0205

Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-05-20 (study day 195); relationship: N; serious criteria: hospitalization

serious SITE010-0206

Grade 3 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2022-11-13 (study day 5); relationship: not assessed; serious criteria: hospitalization

serious SITE010-0248

Grade 4 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-01-02 (study day 8); relationship: Y; serious criteria: life-threatening

serious SITE010-0279

Grade 4 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-04-25 (study day 440); relationship: not assessed; serious criteria: life-threatening

serious SITE010-0294

Grade 4 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-04-21 (study day 53); relationship: N; serious criteria: life-threatening

serious SITE010-0429

Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-12-30 (study day 125); relationship: not assessed; serious criteria: hospitalization

QA findings (3 open)

open major

MISSED REQUIRED EFFICACY ASSESSMENT: Scan window exceeded by >2 weeks for ≥2 cycles (subject SITE010-0039, 2022-10-09)

open major

ENROLLMENT/ELIGIBILITY CRITERIA NOT MET: Subject enrolled despite failing inclusion criterion 4 (ECOG PS) (subject SITE010-0039, 2023-03-16)

resolved minor

LATE ASSESSMENT: Safety assessment delayed (subject SITE010-0046, 2024-12-22)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE010-0094, 2022-09-25)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE010-0094, 2022-11-29)

resolved minor

LATE ASSESSMENT: Tumour assessment performed >7 days late (subject SITE010-0094, 2022-12-01)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE010-0101, 2023-01-21)

open major

PROHIBITED CONCOMITANT MEDICATION: Subject received live attenuated vaccine during treatment period (subject SITE010-0111, 2023-02-12)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE010-0111, 2023-03-28)

resolved minor

LATE ASSESSMENT: ECOG performance status assessment missed (subject SITE010-0127, 2022-10-13)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Cycle administered >7 days late (subject SITE010-0127, 2023-02-22)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE010-0127, 2023-07-03)

Visits & payments

Nothing scheduled.

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