APROMISS: catequentinib (AL3818) in ASPS, leiomyosarcoma and synovial sarcoma

assess serious event

Non-serious event needing physician assessment — Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)

assess serious event

SAE — SAE Narrative Subject NCT03016819-P02 is a 39-year-old female enrolled in treatment arm Placebo (LMS). The subject experienced an adverse event classified as Grade 3 and reported as serious. The event term has not yet been coded; system organ class is [PENDING — human input]. Source of information: Participant-reported via Luna chat: "I've had a high fever since last night". Solicited symptom report; requires clinical characterization. Onset date: [PENDING — human input] Outcome: [PENDING — human input] Date of resolution (if applicable): [PENDING — human input] Action taken with study treatment: [PENDING — human input] Causality: Investigator causality assessment has not been performed. Causality category is currently unassessed. Investigator causality assessment required before this narrative can be finalized. Expectedness: Expectedness undetermined — event has not yet been coded against the reference safety information. Death within 30 days of event: No. Regulatory reporting: This event has been identified as meeting criteria for expedited reporting under a 15-day timeline (ICH E2A, other serious unexpected event category). The expedited report is due on 2026-10-23. Additional clin [narrative drafted by claude-sonnet-5; verify against source fields]

assess serious event

SAE — SAE Narrative Subject NCT03016819-P02 is a 39-year-old female enrolled in the Placebo (LMS) arm who experienced a serious adverse event, Grade 3 in severity. Event term: [PENDING — human input] (event not yet coded). System organ class: [PENDING — human input]. Onset date: [PENDING — human input]. Source/reported description: Participant-reported via Luna chat: "high fever". Solicited symptom report; requires clinical characterization. Action taken with study treatment: [PENDING — human input]. Outcome: [PENDING — human input]. Date of resolution (if applicable): [PENDING — human input]. Investigator causality assessment: not assessed — investigator assessment required. Causality category on file: unassessed. Expectedness: expectedness undetermined — event not yet coded. Death within 30 days of event: No. Regulatory reporting: This event meets criteria for expedited reporting under ICH E2A as a serious, other unexpected event, subject to a 15-day reporting clock. Expedited report due on 2026-10-23. Narrative summary: A 39-year-old female subject in the Placebo (LMS) arm experienced a [narrative drafted by claude-sonnet-5; verify against source fields]

assess serious event

Non-serious event needing physician assessment — Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)

luna withdrawal signal

Participant Grace Nakamura voiced withdrawal intent to Luna. Site coordinator outreach requested — participation is voluntary; only support, never pressure.

luna low mood followup

Participant Grace Nakamura has reported feeling 2/5 then 2/5 in consecutive Luna check-ins. Proactive site outreach proposed.