Review queue

SAE — SAE Narrative Subject SITE001-0066 (58-year-old male) experienced a serious adverse event graded as Grade 3 in severity. The event term has not yet been coded; system organ class is [PENDING — human input]. Source information: Participant-reported via Luna chat: "severe shortness of breath and chest pain since this morning." This is a solicited symptom report and requires clinical characterization. Onset date: [PENDING — human input]. Treatment arm: withheld, as the study remains blinded. Action taken with study treatment: [narrative drafted by claude-sonnet-5; verify against source fields]

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

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

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

Milestone invoice of 23,500 USD from SITE001 (USA) (cycle-3 visit completions) is due in 30 days. Finance must approve release.

IND annual report for CTX-NSCLC-301 compiled by regulatory affairs (enrollment, safety summary, protocol changes). Sign-off required before submission to FDA.

Protocol v0.1-auto (pending_review) for study "A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer" needs medical review. 61 SPIRIT items checked, 42 gaps: 2 critical, 18 major, 22 minor; amendment risk 1.0 (heuristic weights 0.04/0.08/0.15). Critical: data monitoring committee or safety review committee (SPIRIT 21a) — left as placeholder; harms plan: harm stopping criteria / formal stopping rules (SPIRIT 21b / Phillips 2019) — left as placeholder. The reviewer decides whether the draft is approved, revised or rejected.

Escalated by protocol_agent claude-sonnet-5 · 20 d ago

Screening plan for "A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer": 60 candidates to screen over the next 30 days across 15 open sites (Pace: pace ratio 1.02 vs pro-rata plan (317/450 accrued, ~309 expected by now); projected last-patient-in 2027-03-14 at the trailing-3-month pace (23.0/month). eligibility yield Y=0.4850). Per site — SITE001 (USA): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4) · SITE002 (USA): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4) · SITE003 (CAN): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4) · SITE004 (DEU): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4) · SITE005 (FRA): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4) · SITE006 (GBR): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4; 19 consents vs site median 21.0) · SITE007 (JPN): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4; 19 consents vs site median 21.0) · SITE008 (KOR): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4; 19 consents vs site median 21.0) · SITE009 (AUS): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4; 20 consents vs site median 21.0) · SITE010 (ESP): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4; 20 consents vs site median 21.0) · SITE011 (ITA): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4) · SITE012 (BRA): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4) · SITE013 (USA): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4) · SITE014 (NLD): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4; 19 consents vs site median 21.0) · SITE015 (POL): 4 (share 8.9 of 133 remaining ÷ Y 0.485 ÷ 5.9 months = 4). Source: partner:ehr-matching (planning estimate). Approve import for screening — matching never auto-enrolls.

Escalated by recruitment_agent claude-sonnet-5 · 20 d ago

Site "SITE006 (GBR)" is a statistical outlier among the 15 sites of "A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer" (risk score 0.459; withdrawal rate 11% vs study mean 2%, z=3.01; SAE rate 0.68 vs study mean 0.31, z=2.29; enrollment per open month 1.46 vs study mean 1.71, z=-1.64). An on-site visit is proposed for 2026-10-03; the other sites stay on remote/centralized monitoring.

Escalated by monitoring_agent claude-sonnet-5 · 20 d ago

Site "SITE009 (AUS)" is a statistical outlier among the 15 sites of "A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer" (risk score 0.399; lab flags per patient 24.05 vs study mean 16.95, z=2.64). An on-site visit is proposed for 2026-10-03; the other sites stay on remote/centralized monitoring.

4 data queries are open past the 14-day SLA on "A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer" (4 past 30 days, 0 safety-critical P1). JSCDM benchmark: ≥80% reviewed within 2 weeks, target 95%. Oldest: [AE-001 · 285 d] AE Fatigue (grade 1) for SITE002-0071 has onset 2025-12-08, 1 d before first dose on 2025-12-09. Confirm onset; [AE-001 · 251 d] AE Asthenia (grade 1) for SITE012-0100 has onset 2026-01-11, 1 d before first dose on 2026-01-12. Confirm onse; [AE-001 · 106 d] AE Anaemia (grade 1) for SITE010-0221 has onset 2026-06-05, 1 d before first dose on 2026-06-06. Confirm onset; [AE-001 · 31 d] AE Diarrhoea (grade 2) for SITE014-0280 has onset 2026-08-19, 1 d before first dose on 2026-08-20. Confirm ons

Escalated by cdm_agent claude-sonnet-5 · 20 d ago

OVERDUE SAE — SAE Narrative Subject SITE012-0012 (58-year-old male) experienced a serious adverse event of Grade 3 Diarrhoea (System Organ Class: Gastrointestinal disorders), meeting seriousness criteria of hospitalization. Onset date: 2026-08-20. Resolution date: 2026-08-30. Outcome: RECOVERED/RESOLVED. Study treatment arm: withheld — study is blinded. Action taken with study treatment: DRUG WITHDRAWN. Causality assessment: Investigator causality assessment has not been completed. [PENDING — human input] Expectedness: Reported as expected for the anti-PD-1 class per the pembrolizumab label. Expedited reporting: Expedited due date on record is 2026-09-04. This deadline appears to be OVERDUE based on the data provided. Although the event is described as label-listed, confirmation is required from the physician as to whether expedited reporting still applies. [PENDING — human input] Death within 30 days: No. Additional source description on file: Grade 3 Diarrhoea — outcome: RECOVERED/RESOLVED; onset 2023-02-13 ( Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78. [narrative drafted by claude-sonnet-5; verify against source fields]

Escalated by safety_agent claude-sonnet-5 · 20 d ago

OVERDUE SAE — Subject SITE013-0278 (64-year-old F) experienced Grade 3 Asthenia (General disorders and administration site conditions), serious (hospitalization). Onset 2026-08-30; ongoing. Outcome: NOT RECOVERED/NOT RESOLVED. Action taken with study treatment: DOSE REDUCED. Investigator causality NOT RELATED (not suspected). Expectedness: expected for anti-PD-1 class per pembrolizumab label. Existing expedited deadline 2026-09-14 kept although the term is label-listed — physician to confirm whether expedited reporting still applies — OVERDUE. Arm withheld: study is blinded. Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78.

OVERDUE SAE — Subject SITE015-0227 (61-year-old M) experienced Grade 3 Neutropenia (Blood and lymphatic system disorders), serious (hospitalization). Onset 2026-09-01; ongoing. Outcome: NOT RECOVERED/NOT RESOLVED. Action taken with study treatment: DRUG WITHDRAWN. Investigator causality NOT RELATED (not suspected). Expectedness: expected for anti-PD-1 class per pembrolizumab label. Existing expedited deadline 2026-09-16 kept although the term is label-listed — physician to confirm whether expedited reporting still applies — OVERDUE. Arm withheld: study is blinded. Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78.

OVERDUE SAE — Subject SITE007-0138 (59-year-old F) experienced Grade 4 Fatigue (General disorders and administration site conditions), serious (life-threatening). Onset 2026-09-02, resolved 2026-09-13 (11 days). Outcome: RECOVERED/RESOLVED. Action taken with study treatment: DOSE REDUCED. Investigator causality RELATED (suspected). Expectedness: expected for anti-PD-1 class per pembrolizumab label. Existing expedited deadline 2026-09-17 kept although the term is label-listed — physician to confirm whether expedited reporting still applies — OVERDUE. Arm withheld: study is blinded. Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78.

SAE — SAE Narrative Subject SITE012-0203 (60-year-old male) experienced a serious adverse event of Diarrhoea (Grade 3, System Organ Class: Gastrointestinal disorders). The event met serious Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78. [narrative drafted by claude-sonnet-5; verify against source fields]

SAE — Subject SITE005-0273 (79-year-old F) experienced Grade 3 Thrombocytopenia (Blood and lymphatic system disorders), serious (hospitalization). Onset 2026-09-05; ongoing. Outcome: NOT RECOVERED/NOT RESOLVED. Action taken with study treatment: DOSE REDUCED. Investigator causality not assessed — investigator assessment required. Expectedness: expected for anti-PD-1 class per pembrolizumab label. Existing expedited deadline 2026-09-20 kept although the term is label-listed — physician to confirm whether expedited reporting still applies. Arm withheld: study is blinded. Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78.

SAE — Subject SITE006-0258 (61-year-old M) experienced Grade 3 Nausea (Gastrointestinal disorders), serious (hospitalization). Onset 2026-09-05, resolved 2026-09-10 (5 days). Outcome: RECOVERED/RESOLVED. Action taken with study treatment: DOSE REDUCED. Investigator causality NOT RELATED (not suspected). Expectedness: expected for anti-PD-1 class per pembrolizumab label. Existing expedited deadline 2026-09-20 kept although the term is label-listed — physician to confirm whether expedited reporting still applies. Arm withheld: study is blinded. Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78.

SAE — SAE Narrative Subject SITE007-0231 (46-year-old male) experienced a Grade 3 serious adverse event of Adrenal insufficiency (System Organ Class: Endocrine disorders). The event met seriousness criteria due to hosp Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78. [narrative drafted by claude-sonnet-5; verify against source fields]

SAE — SAE Narrative Subject SITE015-0186 (50-year-old male) experienced a serious adverse event of Constipation (Gastrointestinal disorders), Grade 4, assessed as serious due to life-threatening criteria. Onset: 2026-09-10. Outcome at time of reporting: NOT RECOVERED/NOT RESOLVED. Note: The source description associated with this event records onset as 2023-03-06 (study day 134) and outcome as RECOVERED/RESOLVED, which conflicts with the onset and outcome fields above. This discrepancy has not been resolved in the Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78. [narrative drafted by claude-sonnet-5; verify against source fields]

SAE — Subject SITE001-0119 (62-year-old M) experienced Grade 4 Neutropenia (Blood and lymphatic system disorders), serious (life-threatening). Onset 2026-09-13; ongoing. Outcome: NOT RECOVERED/NOT RESOLVED. Action taken with study treatment: DOSE NOT CHANGED. Investigator causality NOT RELATED (not suspected). Expectedness: expected for anti-PD-1 class per pembrolizumab label. Existing expedited deadline 2026-09-28 kept although the term is label-listed — physician to confirm whether expedited reporting still applies. Arm withheld: study is blinded. Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78.

SAE — SAE Narrative Subject SITE011-0239 (49-year-old female) experienced a serious adverse event of Anaemia (System Organ Class: Blood and lymphatic system disorders), Grade 3, meeting seriousness criteria of hospitalization. Per the structured event data, onset occurred on 2026-09-13 and the event is ongoing, with an outcome of NOT RECOVERED/N Aggregate review over 1043 events: FAERS class disproportionality flags (screening only): Neutropenia PRR 2.64; Anaemia PRR 2.56; Thrombocytopenia PRR 3.02; Peripheral neuropathy PRR 3.01; Decreased appetite PRR 2.78. [narrative drafted by claude-sonnet-5; verify against source fields]

27 patient(s) at elevated dropout risk on "A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer": SITE013-0226 @ SITE013 (USA) p=0.472 (1 grade ≥3 AE(s), 1 serious AE(s) in last 60 d, treatment stopped 40 d ago); SITE013-0257 @ SITE013 (USA) p=0.472 (1 grade ≥3 AE(s), 1 serious AE(s) in last 60 d, treatment stopped 46 d ago); SITE006-0064 @ SITE006 (GBR) p=0.428 (2 grade ≥3 AE(s), treatment stopped 106 d ago, site withdrawal rate 10.5%); SITE002-0062 @ SITE002 (USA) p=0.401 (1 planned visit(s) missed, 1 grade ≥3 AE(s), treatment stopped 230 d ago); SITE005-0047 @ SITE005 (FRA) p=0.4 (2 grade ≥3 AE(s), treatment stopped 145 d ago, site withdrawal rate 4.8%); SITE005-0139 @ SITE005 (FRA) p=0.4 (2 grade ≥3 AE(s), treatment stopped 59 d ago, site withdrawal rate 4.8%); SITE006-0211 @ SITE006 (GBR) p=0.38 (3 grade ≥3 AE(s), 1 serious AE(s) in last 60 d, site withdrawal rate 10.5%); SITE001-0092 @ SITE001 (USA) p=0.378 (2 grade ≥3 AE(s), treatment stopped 152 d ago); SITE003-0051 @ SITE003 (CAN) p=0.378 (2 grade ≥3 AE(s), treatment stopped 245 d ago); SITE007-0085 @ SITE007 (JPN) p=0.378 (3 grade ≥3 AE(s), treatment stopped 188 d ago); SITE008-0067 @ SITE008 (KOR) p=0.378 (2 grade ≥3 AE(s), treatment stopped 163 d ago); SITE015-0117 @ SITE015 (POL) p=0.378 (2 grade ≥3 AE(s), treatment stopped 149 d ago); SITE005-0273 @ SITE005 (FRA) p=0.353 (4 grade ≥3 AE(s), 1 serious AE(s) in last 60 d, site withdrawal rate 4.8%); SITE011-0239 @ SITE011 (ITA) p=0.351 (2 grade ≥3 AE(s), 2 serious AE(s) in last 60 d, site withdrawal rate 4.2%); SITE013-0173 @ SITE013 (USA) p=0.351 (3 grade ≥3 AE(s), 1 serious AE(s) in last 60 d, site withdrawal rate 4.3%) … +12 more in the run evidence. Approve proactive site outreach before disengagement — no participant is contacted without this approval.

Escalated by retention_agent claude-sonnet-5 · 20 d ago

1 early-termination risk flag(s) on "A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer": Serious-AE density 30.9% (98 serious AEs / 317 enrolled; threshold 30.0%, escalation-pressure proxy). Accrued 317 of 450 — pace ratio 102.5% of the pro-rata plan (~309 expected by month 14), trailing 3-month pace 22.72/month; projected last patient in 2027-03-16, 0.1 months ahead of plan (trailing 3-month pace). Implied early-termination probability 16.7% (base rate 23.5% from ClinicalTrials.gov Non-Small Cell Lung Cancer phase 3 (118/501 closed trials terminated; snapshot 2026-09-19T08:06:16Z); footprint 13 countries OR 0.65; Zhang & DuBois 2023, Cancer Med 12:5517–5525). ClinicalTrials.gov comparator Non-Small Cell Lung Cancer phase 3: 118 of 1025 registered trials terminated (11.5%; 23.5% of closed trials), 32 for accrual (27.1% of terminations); median enrollment 153.5 terminated vs 438 completed; e.g. NCT00003803, NCT00032084, NCT00091156. Termination is a human decision — only efficacy, safety, or feasibility justify it (Lièvre et al. 2001, BMJ 322:603–605).

Escalated by termination_watch_agent claude-sonnet-5 · 20 d ago

7 auto-generated TLF outputs (ICH E3 Section 14, batch 476ab4f205a31270) for "A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer" await double-programming-equivalent validation.

Escalated by biostats_agent claude-sonnet-5 · 10 d ago

Interim Safety and Status Report (draft) for "A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer" needs medical writing review and sign-off.

Escalated by medical_writing_agent claude-sonnet-5 · 20 d ago

TMF for "A Phase III, Randomized, Double-Blind Study of Torivumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Previously Untreated Advanced Non-Small Cell Lung Cancer" is 65% complete against the DIA TMF Reference Model v3.2.1 (conduct stage); 8 auditable artifact(s) missing or incomplete — top gaps: 07.02.01 Expedited Safety Report, 02.01.02 Protocol, 03.01.01 Regulatory Submission. Confirm the filed TMF findings and assign owners.

Escalated by tmf_agent claude-sonnet-5 · 20 d ago

Site "Royal Perth Hospital (Perth, Australia)" is a statistical outlier among the 34 sites of "A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma" (risk score 0.496; visit-window compliance 50% vs study mean 88%, z=-2.92; missed-visit rate 12% vs study mean 3%, z=2.73). An on-site visit is proposed for 2026-10-13; the other sites stay on remote/centralized monitoring.

Escalated by monitoring_agent claude-sonnet-5 · 10 d ago

Site "State Health Centre Oncology Department (Budapest, Hungary)" is a statistical outlier among the 34 sites of "A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma" (risk score 0.359; enrollment per open month 2.11 vs study mean 0.67, z=3.36). An on-site visit is proposed for 2026-10-13; the other sites stay on remote/centralized monitoring.

Site "Lviv State Oncological Regional Treatment - Diagnostics Center, Chemotherapy Department (Lviv, Ukraine)" is a statistical outlier among the 34 sites of "A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma" (risk score 0.34; lab flags per patient 18.00 vs study mean 9.74, z=2.54). An on-site visit is proposed for 2026-10-13; the other sites stay on remote/centralized monitoring.

86 data queries are open past the 14-day SLA on "A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma" (86 past 30 days, 16 safety-critical P1). JSCDM benchmark: ≥80% reviewed within 2 weeks, target 95%. Oldest: [AE-006 · 5298 d] AE Anaemia (grade 4) for P2B-001 (onset 2012-03-28) is CTCAE grade 4 but not flagged serious. Confirm seriousn; [AE-006 · 5292 d] AE Neutropenia (grade 4) for P2B-003 (onset 2012-04-03) is CTCAE grade 4 but not flagged serious. Confirm seri; [VS-001 · 5230 d] Visit Cycle 2 Day 1: infusion (V3) for P2B-005 occurred on 2012-06-04, 5 d late against planned day 22 (2012-0; [VS-001 · 5210 d] Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-005 occurred on 2012-06-; [VS-001 · 5208 d] Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-003 occurred on 2012-06

Escalated by cdm_agent claude-sonnet-5 · 10 d ago

OVERDUE SAE — SAE Narrative Subject P2B-132 (46-year-old male), enrolled in the Aldoxorubicin (INNO-206) 350 mg/m2 treatment arm, experienced a serious adverse event of Cholecystitis (System Organ Class: Hepatobiliary disorders), assessed as Grade 3 in severity. The event met the criterion of seriousness due to hospitalization. Onset occurred on 2013-09-29, with resolution on 2013-10-13, for a total duration of 14 days. The outcome was reported as RECOVERED/RESOLVED. The investigator's causality assessment was UNLIKELY (not suspected as related to study treatment). No dose adjustment was made as a result of this event (action taken with study treatment: DOSE NOT CHANGED). This event was classified as unexpected, as it is not listed on the doxorubicin hydrochloride label (doxorubicin class proxy). As an unexpected serious adverse event assessed as not related to study drug, expedited reporting was required within 15 days per ICH E2A guidelines, with a due date of 2013-10-14. This report is OVERDUE. Death within 30 days of the event: No. Additional Aggregate review over 608 events: potential new signal(s) not on the class label with ≥3 serious cases: Anaemia (9 patients, 9 serious events); Febrile neutropenia (16 patients, 16 serious events); Pyrexia (3 patients, 3 serious events); Cellulitis (3 patients, 3 serious events). FAERS class disproportionality flags (screening only): Anaemia PRR 4.8; Neutropenia PRR 11.37; Alopecia PRR 3.19; Febrile neutropenia PRR 36.86; Thrombocytopenia PRR 8.12; Pyrexia PRR 2.79. [narrative drafted by claude-sonnet-5; verify against source fields]

Escalated by safety_agent claude-sonnet-5 · 10 d ago

OVERDUE SAE — SAE Narrative – Subject P2B-130 Subject P2B-130 is a 51-year-old female enrolled in the study arm Aldoxorubicin (INNO-206) 350 mg/m2. The subject experienced a serious adverse event of Anaemia (Grade 3), System Organ Class: Blood and lymphatic system disorders, classified as serious due to hospitalization. Onset of the event occurred on 2013-10-17, with resolution documented on 2013-11-10, corresponding to a duration of 24 days. The outcome was reported as RECOVERED/RESOLVED. Following the onset of the event, the action taken with study treatment was DRUG INTERRUPTED. The investigator's assessment of causality was PROBABLE, and the event was categorized as suspected (related to study drug). The event was assessed as unexpected — not listed on the doxorubicin hydrochloride label (doxorubicin class proxy). Per ICH E2A expedited reporting requirements, this event triggered a 15-day reporting clock, with an expedited report due on 2013-11-01. This report is OVERDUE. Death within 30 days of the event: No. Additional source description: Grade 3 Aggregate review over 608 events: potential new signal(s) not on the class label with ≥3 serious cases: Anaemia (9 patients, 9 serious events); Febrile neutropenia (16 patients, 16 serious events); Pyrexia (3 patients, 3 serious events); Cellulitis (3 patients, 3 serious events). FAERS class disproportionality flags (screening only): Anaemia PRR 4.8; Neutropenia PRR 11.37; Alopecia PRR 3.19; Febrile neutropenia PRR 36.86; Thrombocytopenia PRR 8.12; Pyrexia PRR 2.79. [narrative drafted by claude-sonnet-5; verify against source fields]

OVERDUE SAE — SAE Narrative Subject P2B-134 is a 66-year-old female enrolled in the study arm Aldoxorubicin (INNO-206) 350 mg/m2. The subject experienced a serious adverse event of Anaemia (System Organ Class: Blood and lymphatic system disorders), Grade 3, classified as serious due to hospitalization. Onset of the event occurred on 2013-10-22. The event resolved on 2013-11-26, with an event duration of 35 days. The outcome was reported as RECOVERED/RESOLVED. As a result of the event, the following action was taken with study treatment: DOSE REDUCED. The investigator's assessment of causality was PROBABLE, and the event was categorized as suspected in relation to study treatment. Expectedness assessment: unexpected — not listed on the doxorubicin hydrochloride label (doxorubicin class proxy). Death within 30 days of the event: No. Regulatory reporting: This event met criteria for expedited reporting under a 15-day timeline (ICH E2A). The expedited report was due on 2013-11-06. Based on the information provided, this report is OVERDUE. Additional narrative detail from source Aggregate review over 608 events: potential new signal(s) not on the class label with ≥3 serious cases: Anaemia (9 patients, 9 serious events); Febrile neutropenia (16 patients, 16 serious events); Pyrexia (3 patients, 3 serious events); Cellulitis (3 patients, 3 serious events). FAERS class disproportionality flags (screening only): Anaemia PRR 4.8; Neutropenia PRR 11.37; Alopecia PRR 3.19; Febrile neutropenia PRR 36.86; Thrombocytopenia PRR 8.12; Pyrexia PRR 2.79. [narrative drafted by claude-sonnet-5; verify against source fields]

OVERDUE SAE — Serious Adverse Event Narrative Subject P2B-134 is a 66-year-old female enrolled in the study, assigned to the Aldoxorubicin (INNO-206) 350 mg/m2 treatment arm. The subject experienced a serious adverse event of Febrile neutropenia (System Organ Class: Blood and lymphatic system disorders), graded as Grade 4 in severity. The event met seriousness criteria on the basis of hospitalization. Onset of the event occurred on 2013-10-29, with resolution documented on 2013-11-04, for a total event duration of 6 days. The outcome was reported as RECOVERED/RESOLVED. In response to the event, study treatment action taken was DRUG INTERRUPTED. The investigator's assessment of causality was PROBABLE, and the event was categorized as suspected in relation to study treatment. The event was assessed as unexpected, as it is not listed on the doxorubicin hydrochloride label (used as a doxorubicin class proxy reference). Regulatory reporting: Per the applicable expedited reporting clock (15 days, consistent with ICH E2A for other serious unexpected suspected adverse reactions), the exp Aggregate review over 608 events: potential new signal(s) not on the class label with ≥3 serious cases: Anaemia (9 patients, 9 serious events); Febrile neutropenia (16 patients, 16 serious events); Pyrexia (3 patients, 3 serious events); Cellulitis (3 patients, 3 serious events). FAERS class disproportionality flags (screening only): Anaemia PRR 4.8; Neutropenia PRR 11.37; Alopecia PRR 3.19; Febrile neutropenia PRR 36.86; Thrombocytopenia PRR 8.12; Pyrexia PRR 2.79. [narrative drafted by claude-sonnet-5; verify against source fields]

OVERDUE SAE — Serious Adverse Event Narrative Subject P2B-129 is a 64-year-old female enrolled in the study arm receiving Doxorubicin 75 mg/m2. The subject experienced a serious adverse event of Anaemia (System Organ Class: Blood and lymphatic system disorders), Grade 3, classified as serious due to hospitalization. Onset occurred on 2013-10-30, with cycle 5 onset noted in the source description. The event resolved on 2013-12-02, resulting in an event duration of 33 days. As a result of the event, study treatment action taken was: drug interrupted. The event outcome was recorded as RECOVERED/RESOLVED. The investigator's causality assessment was PROBABLE, and the causality category was classified as suspected (related to study drug). The event was assessed as unexpected — not listed on the doxorubicin hydrochloride label (doxorubicin class proxy). Death within 30 days of the event: No. Regulatory Reporting Status: Per ICH E2A guidelines, this event met criteria for expedited reporting under the 15-day serious unexpected reaction timeline. The expedited report was due on 2013-11-14. This report is Aggregate review over 608 events: potential new signal(s) not on the class label with ≥3 serious cases: Anaemia (9 patients, 9 serious events); Febrile neutropenia (16 patients, 16 serious events); Pyrexia (3 patients, 3 serious events); Cellulitis (3 patients, 3 serious events). FAERS class disproportionality flags (screening only): Anaemia PRR 4.8; Neutropenia PRR 11.37; Alopecia PRR 3.19; Febrile neutropenia PRR 36.86; Thrombocytopenia PRR 8.12; Pyrexia PRR 2.79. [narrative drafted by claude-sonnet-5; verify against source fields]

12 auto-generated TLF outputs (ICH E3 Section 14, batch 8b11fd774ddf26c5) for "A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma" await double-programming-equivalent validation.

Escalated by biostats_agent claude-sonnet-5 · 10 d ago

Clinical Study Report (draft) for "A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma" needs medical writing review and sign-off.

Escalated by medical_writing_agent claude-sonnet-5 · 10 d ago

TMF for "A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma" is 60% complete against the DIA TMF Reference Model v3.2.1 (closeout stage); 10 auditable artifact(s) missing or incomplete — top gaps: 03.01.01 Regulatory Submission, 07.02.01 Expedited Safety Report, 02.03.01 Clinical Study Report. Confirm the filed TMF findings and assign owners.

Escalated by tmf_agent claude-sonnet-5 · 10 d ago

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)

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]

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]

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)

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

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

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)

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)

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)

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)

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)

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)

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)

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)

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)

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

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

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)

SAE — SAE Narrative Subject: NCT05642455-P02 Age/Sex: 15-year-old female Study arm: [PENDING — human input] Event: Adverse event, not yet coded (System Organ Class: [PENDING — human input]) Seriousness: Serious Severity grade: Grade 3 Onset date: [PENDING — human input] Outcome: [PENDING — human input] Resolution date: [PENDING — human input] Action taken: [PENDING — human input] Source information: Participant-reported via Luna chat: "I've had a high fever since last night." This is a solicited symptom report and requires clinical characterization. Causality ass [narrative drafted by claude-sonnet-5; verify against source fields]

SAE — SAE Narrative Subject: NCT05642455-P02 Age/Sex: 15-year-old female Treatment Arm: [PENDING — human input] Event Description: Adverse event, not yet coded (System Organ Class: [PENDING — human input]). The event was reported as serious and graded as Grade 3 in severity. Source of Report: Participant-reported via Luna chat: "high fever." This is a solicited symptom report and requires clinical characterization. Onset Date: [PENDING — human input] Outcome: [PENDING — human input] [narrative drafted by claude-sonnet-5; verify against source fields]

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)

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)

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)

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)

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)

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)

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)

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

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

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)

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)

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)

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)

SAE — SAE Narrative Subject: NCT06975293-P02 Sex: F Age: 31 Treatment arm: STC-15 monotherapy (sarcoma) Event: Adverse event (uncoded; system organ class not yet assigned: [PENDING — human input]) Seriousness: Serious Grade (severity): Grade 3 Onset date: [PENDING — human input] Source/description: Participant-reported via Luna chat: "I've had a high fever since last night." 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] Causality assessment (investigator): [PENDING — human [narrative drafted by claude-sonnet-5; verify against source fields]

SAE — SAE Narrative Subject: NCT06975293-P02 (31-year-old female), enrolled in the STC-15 monotherapy (sarcoma) treatment arm. Event: The subject experienced an adverse event, currently uncoded, graded as Grade 3 and classified as serious. System organ class: [PENDING — human input]. Source: Event was participant-reported via Luna chat, described as "high fever." This is a solicited symptom report that requires clinical characterization. [PENDING — human input] Onset: Onset date not recorded. [PENDING — human input] Causality: Investigator causality assessment has not been completed. Causality category: unassessed. [PEND [narrative drafted by claude-sonnet-5; verify against source fields]

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)

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)

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)

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)

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

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

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)

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)

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)

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)

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)

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)

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)

SAE — SAE Narrative Subject NCT07705334-P02 is a 57-year-old female enrolled in study NCT07705334, treatment arm: [PENDING — human input]. The subject experienced a serious adverse event (Grade 3), currently uncoded, as reported via participant-reported source: Luna chat message, "I've had a high fever since last night." This was a solicited symptom report and requires clinical characterization. Onset date: [PENDING — human input] System organ class: [PENDING — human input] Action taken with study treatment: [PENDING — human input] Outcome: [PENDING — human input] Date of resolution (if applicable): [PENDING — human input] Death within 30 days of event: No Causality: Investigator causality assessment has not yet been recorded. [PENDING — human input] Expectedness: Expectedness undetermined — event not yet coded. [PENDING — human input] Regulatory Reporting: This event has been classified as serious. Per ICH E2A requirements, an expedited report is due on 2026-10-23, consistent with the 15-day reporting clock applicable to other serious unexpected events. This narrative will be updated upon receipt of additional clinical information, including invest [narrative drafted by claude-sonnet-5; verify against source fields]

SAE — SAE Narrative Subject NCT07705334-P02 (57-year-old female; treatment arm: [PENDING — human input]) experienced a serious adverse event, Grade 3 in severity. The event has not yet been coded; the uncoded term is based on participant-reported information via Luna chat ("high fever"), a solicited symptom report that requires clinical characterization. Onset date: [PENDING — human input] System organ class: [PENDING — human input] Action taken with study treatment: [PENDING — human input] Outcome: [PENDING — human input] Resolution date: [PENDING — human input] Investigator causality assessment: not assessed — investigator assessment required. Expectedness: expectedness undetermined — event not yet coded. Seriousness: serious. Death within 30 days of event: no. Regulatory reporting: This event falls under the 15-day expedited reporting timeline (other serious, unexpected) per ICH E2A. The expedited report is due on 2026-10-23. Additional clinical details, including a fully characterized diagnosis, SOC/coded term, and investigator causality assessment, are pending and required prior to finalization of this narrative. [narrative drafted by claude-sonnet-5; verify against source fields]

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)

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

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

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)

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)

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)

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)

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)

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)

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)

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)

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)

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

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