GalenOps prod · 0.1.0

Adverse events

8

Serious AEs

0

Open data queries

1

Luna dropout signal

—

not on Luna

Adverse events 8

mild assessed 2025-12-08

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-06-03 (study day 59); relationship: not assessed

mild assessed 2025-12-02

Grade 1 Neutropenia — outcome: RECOVERED/RESOLVED; onset 2022-05-28 (study day 53); relationship: NOT RELATED

moderate assessed 2025-11-25

Grade 2 Constipation — outcome: RECOVERED/RESOLVED; onset 2022-05-21 (study day 46); relationship: not assessed

mild assessed 2025-11-14

Grade 1 Fatigue — outcome: RECOVERED/RESOLVED; onset 2022-05-10 (study day 35); relationship: not assessed

moderate assessed 2025-10-31

Grade 2 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-04-26 (study day 21); relationship: RELATED

moderate assessed 2025-10-30

Grade 2 Nausea — outcome: RECOVERED/RESOLVED; onset 2022-04-25 (study day 20); relationship: not assessed

mild assessed 2025-10-29

Grade 1 Anaemia — outcome: RECOVERED/RESOLVED; onset 2022-04-24 (study day 19); relationship: not assessed

moderate assessed 2025-10-13

Grade 2 Alopecia — outcome: RECOVERED/RESOLVED; onset 2022-04-08 (study day 3); relationship: not assessed

Data queries 1

F.VS.SYSBP (Systolic blood pressure) open

EDC value 113 differs from the EHR: 131 mmHg (Observation/vs-7d2882169021-8480-6-20251011, 2025-10-11; EHR stated 131 mm[Hg]). Confirm against source and correct or explain.

Luna engagement

This participant doesn't use Luna

Invite them from the site to track mood, adherence and check-ins.