SITE011-0297

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
SITE011 (ITA) · Dr. Jansen

consented 2023-02-21

AEs
11
Serious
1
Dropout signal

Adverse events

moderate assessed

Grade 2 Rash — outcome: RECOVERED/RESOLVED; onset 2023-04-02 (study day 32); relationship: not assessed

mild assessed

Grade 1 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-05-13 (study day 73); relationship: not assessed

moderate assessed

Grade 2 Adrenal insufficiency — outcome: RECOVERED/RESOLVED; onset 2023-05-28 (study day 88); relationship: not assessed

severe assessed

Grade 3 Pruritus — outcome: RECOVERED/RESOLVED; onset 2023-06-17 (study day 108); relationship: not assessed

moderate assessed

Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-11-25 (study day 269); relationship: N

moderate assessed

Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-03-15 (study day 380); relationship: Y

severe serious assessed

Grade 3 Anaemia — outcome: RECOVERED/RESOLVED; onset 2024-05-07 (study day 433); relationship: not assessed; serious criteria: hospitalization

moderate assessed

Grade 2 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2024-08-26 (study day 544); relationship: N

moderate assessed

Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-09-10 (study day 559); relationship: not assessed

moderate assessed

Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2024-11-29 (study day 639); relationship: not assessed

mild assessed

Grade 1 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2024-12-19 (study day 659); relationship: N

Data queries

No data queries.