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SITE002-0241

completed

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
SITE002 (USA) · Dr. Nolan
consented 2022-12-04

AEs
10
Serious
2
Dropout signal
–

Adverse events

mild assessed

Grade 1 Adrenal insufficiency — outcome: RECOVERED/RESOLVED; onset 2023-01-18 (study day 28); relationship: not assessed

moderate assessed

Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-01-26 (study day 36); relationship: not assessed

mild assessed

Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-06-03 (study day 164); relationship: not assessed

moderate assessed

Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-06-21 (study day 182); relationship: N

severe serious assessed

Grade 4 Fatigue — outcome: RECOVERED/RESOLVED; onset 2023-10-16 (study day 299); relationship: N; serious criteria: life-threatening

moderate assessed

Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-11-21 (study day 335); relationship: N

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-04-12 (study day 478); relationship: Y

moderate assessed

Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2024-05-02 (study day 498); relationship: Y

severe serious assessed

Grade 3 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-06-10 (study day 537); relationship: not assessed; serious criteria: hospitalization

moderate assessed

Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-06-12 (study day 539); relationship: N

Data queries

No data queries.