SITE011-0115

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 2022-07-17

AEs
8
Serious
0
Dropout signal

Adverse events

mild assessed

Grade 1 Colitis — outcome: RECOVERED/RESOLVED; onset 2022-10-01 (study day 70); relationship: not assessed

moderate assessed

Grade 2 Pneumonitis — outcome: RECOVERED/RESOLVED; onset 2022-10-16 (study day 85); relationship: not assessed

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-10-22 (study day 91); relationship: not assessed

moderate assessed

Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-10-28 (study day 97); relationship: not assessed

mild assessed

Grade 1 Hypothyroidism — outcome: RECOVERED/RESOLVED; onset 2022-11-08 (study day 108); relationship: Y

severe assessed

Grade 3 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-01-06 (study day 167); relationship: N

mild assessed

Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-07-02 (study day 344); relationship: N

mild assessed

Grade 1 Peripheral neuropathy — outcome: RECOVERED/RESOLVED; onset 2023-12-14 (study day 509); relationship: not assessed

Data queries

No data queries.