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SITE007-0236

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
SITE007 (JPN) · Dr. Dubois
consented 2022-12-06

AEs
8
Serious
1
Dropout signal
–

Adverse events

mild assessed

Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2022-12-30 (study day 14); relationship: N

moderate assessed

Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-02-16 (study day 62); relationship: not assessed

severe serious assessed

Grade 4 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-10-10 (study day 298); relationship: not assessed; serious criteria: life-threatening

moderate assessed

Grade 2 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-10-13 (study day 301); relationship: not assessed

moderate assessed

Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-11-10 (study day 329); relationship: N

mild assessed

Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2024-02-12 (study day 423); relationship: not assessed

mild assessed

Grade 1 Diarrhoea — outcome: UNKNOWN; onset 2024-02-17 (study day 428); relationship: not assessed

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-03-15 (study day 455); relationship: not assessed

Data queries

No data queries.