SITE007-0378

withdrawn

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 2023-05-13

AEs
8
Serious
2
Dropout signal

Adverse events

mild assessed

Grade 1 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-06-11 (study day 11); relationship: not assessed

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-06-20 (study day 20); relationship: Y

severe assessed

Grade 3 Constipation — outcome: RECOVERED/RESOLVED; onset 2023-06-29 (study day 29); relationship: not assessed

moderate assessed

Grade 2 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-07-07 (study day 37); relationship: not assessed

severe serious assessed

Grade 4 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-06 (study day 98); relationship: not assessed; serious criteria: life-threatening

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-09-12 (study day 104); relationship: not assessed

moderate assessed

Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-10-07 (study day 129); relationship: not assessed

severe serious assessed

Grade 3 Asthenia — outcome: RECOVERED/RESOLVED; onset 2023-10-17 (study day 139); relationship: Y; serious criteria: hospitalization

Data queries

No data queries.