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SITE001-0216

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
SITE001 (USA) · Dr. Reyes
consented 2022-11-06

AEs
10
Serious
1
Dropout signal
–

Adverse events

moderate assessed

Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2022-12-27 (study day 39); relationship: not assessed

moderate assessed

Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-01-08 (study day 51); relationship: N

mild assessed

Grade 1 Vomiting — outcome: RECOVERED/RESOLVED; onset 2023-01-29 (study day 72); relationship: Y

severe serious assessed

Grade 3 Rash — outcome: RECOVERED/RESOLVED; onset 2023-02-03 (study day 77); relationship: Y; serious criteria: hospitalization

mild assessed

Grade 1 Pneumonitis — outcome: RECOVERED/RESOLVED; onset 2023-02-17 (study day 91); relationship: not assessed

mild assessed

Grade 1 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2023-09-27 (study day 313); relationship: N

moderate assessed

Grade 2 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2023-10-29 (study day 345); relationship: not assessed

moderate assessed

Grade 2 Dyspnoea — outcome: RECOVERED/RESOLVED; onset 2024-01-15 (study day 423); relationship: not assessed

moderate assessed

Grade 2 Fatigue — outcome: RECOVERED/RESOLVED; onset 2024-05-11 (study day 540); relationship: Y

mild assessed

Grade 1 Nausea — outcome: RECOVERED/RESOLVED; onset 2024-07-13 (study day 603); relationship: N

Data queries

No data queries.