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SITE008 (KOR)

KRI 0.49
KOR · PI Dr. Kim · activated
Patients
30
Active
0
Serious AEs
19
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)

SITE008-0022 › completed SITE008-0050 › completed SITE008-0052 › completed SITE008-0058 › completed SITE008-0065 › completed SITE008-0067 › completed SITE008-0072 › withdrawn SITE008-0133 › completed SITE008-0136 › completed SITE008-0142 › completed SITE008-0159 › completed SITE008-0160 › withdrawn SITE008-0199 › completed SITE008-0201 › completed SITE008-0228 › completed SITE008-0247 › completed SITE008-0276 › withdrawn SITE008-0284 › completed SITE008-0290 › completed SITE008-0323 › completed SITE008-0326 › completed SITE008-0358 › completed SITE008-0386 › completed SITE008-0398 › completed SITE008-0402 › completed SITE008-0408 › withdrawn SITE008-0432 › completed SITE008-0447 › completed SITE008-0448 › completed SITE008-0450 › completed

Safety — 214 AEs, 19 serious

serious SITE008-0058

Grade 3 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-01-30 (study day 261); relationship: not assessed; serious criteria: hospitalization

serious SITE008-0058

Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-10-11 (study day 881); relationship: N; serious criteria: hospitalization

serious SITE008-0067

Grade 4 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-08-09 (study day 75); relationship: not assessed; serious criteria: life-threatening

serious SITE008-0142

Grade 3 Vomiting — outcome: RECOVERED/RESOLVED; onset 2022-12-03 (study day 102); relationship: N; serious criteria: hospitalization

serious SITE008-0199

Grade 4 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-12-21 (study day 47); relationship: not assessed; serious criteria: life-threatening

serious SITE008-0247

Grade 3 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-01-07 (study day 13); relationship: not assessed; serious criteria: hospitalization

serious SITE008-0247

Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-11-18 (study day 328); relationship: N; serious criteria: hospitalization

serious SITE008-0276

Grade 3 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-09-05 (study day 211); relationship: not assessed; serious criteria: hospitalization

QA findings (3 open)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE008-0022, 2022-04-14)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE008-0022, 2022-06-06)

resolved minor

MISSED ROUTINE ASSESSMENT: Vital signs not recorded at scheduled visit (subject SITE008-0022, 2023-07-23)

resolved minor

MISSED ROUTINE ASSESSMENT: Vital signs not recorded at scheduled visit (subject SITE008-0050, 2022-07-23)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±5 day window (subject SITE008-0050, 2022-08-26)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE008-0050, 2022-11-01)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE008-0050, 2022-11-12)

resolved minor

LATE ASSESSMENT: Safety assessment delayed (subject SITE008-0052, 2022-05-26)

resolved minor

ASSESSMENT OUTSIDE PROTOCOL WINDOW: Visit outside ±3 day window (subject SITE008-0052, 2022-07-10)

resolved minor

MISSED ROUTINE ASSESSMENT: Haematology missed at scheduled visit (subject SITE008-0052, 2022-07-18)

resolved minor

OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE008-0052, 2022-09-11)

resolved minor

OTHER: Sample not stored at correct temperature (excursion <2 hr) (subject SITE008-0065, 2023-08-12)

Visits & payments

Nothing scheduled.

☾ Luna participants

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