SITE001-0066

SITE001 (USA) › SITE001-0066

SITE001-0066

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 2025-11-22

enrolled

AEs

6

Serious

1

Dropout signal

+0.25

Luna — Elif Demir

Consent

granted

Messages

4

Escalations

0 escalations

Mood (avg feeling)

ø 2.5

Meds adherence (7d)

0%

Adverse events

6

Participant-reported via Luna chat: "I've had some nausea since yesterday evening". Solicited symptom report logged for the next visit review.

mild assessed

Participant-reported via Luna chat: "severe shortness of breath and chest pain since this morning". Solicited symptom report; requires clinical characterization.

severe serious under_review

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2023-03-01 (study day 280); relationship: RELATED

mild assessed

Grade 2 Asthenia — outcome: RECOVERED/RESOLVED; onset 2022-11-17 (study day 176); relationship: NOT RELATED

moderate assessed

Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-11-01 (study day 160); relationship: NOT RELATED

moderate assessed

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-08-11 (study day 78); relationship: not assessed

moderate assessed

Data queries

1

AE Adverse event (serious) for SITE001-0066 (onset undated) is flagged serious but no seriousness criterion (death, life-threatening, hospitalization, disability, congenital anomaly, other) is recorded.

serious_criteria[AE undated] open