SITE007-0269

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 2023-01-10

AEs
11
Serious
0
Dropout signal

Adverse events

moderate assessed

Grade 2 Constipation — outcome: UNKNOWN; onset 2023-02-06 (study day 12); relationship: N

mild assessed

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-02-17 (study day 23); relationship: N

mild assessed

Grade 1 Decreased appetite — outcome: RECOVERED/RESOLVED; onset 2023-04-05 (study day 70); relationship: Y

moderate assessed

Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-04-05 (study day 70); relationship: not assessed

severe assessed

Grade 3 Pruritus — outcome: RECOVERED/RESOLVED; onset 2023-04-12 (study day 77); relationship: not assessed

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2023-05-05 (study day 100); relationship: N

severe assessed

Grade 3 Colitis — outcome: RECOVERED/RESOLVED; onset 2023-05-09 (study day 104); relationship: not assessed

mild assessed

Grade 1 Hepatitis — outcome: RECOVERED/RESOLVED; onset 2023-05-22 (study day 117); relationship: not assessed

mild assessed

Grade 1 Stomatitis — outcome: RECOVERED/RESOLVED; onset 2023-05-29 (study day 124); relationship: not assessed

mild assessed

Grade 1 Alopecia — outcome: RECOVERED/RESOLVED; onset 2023-06-02 (study day 128); relationship: N

moderate assessed

Grade 2 Thrombocytopenia — outcome: RECOVERED/RESOLVED; onset 2023-07-07 (study day 163); relationship: Y

Data queries

No data queries.