Forms
22
Visits
15
Fields
71
Subjects
1
Audit Events
110
Completion
68%
Study Information
| Study ID | 7c221213-642b-4df0-b33d-bfa0c84fc28e |
| Short Name | FLAURA2 |
| Phase | Phase III |
| Status | Active |
| Sponsor | AstraZeneca |
| Indication | EGFR-mutated advanced NSCLC |
| Intervention | Osimertinib 80mg QD ± Carboplatin/Pemetrexed |
| Created | 2025-01-10 |
Completion by Visit
Form Categories
Safety (Hematology, Chemistry, AEs)72%
Efficacy (Response, PRO)61%
Demographics & Eligibility100%
Drug Administration55%
Study Description
FLAURA2 is a randomised, double-blind, placebo-controlled Phase III study evaluating the efficacy and safety of osimertinib in combination with platinum-based chemotherapy versus osimertinib alone as first-line treatment in patients with EGFR-mutated (Ex19del or L858R) advanced non-small cell lung cancer. Primary endpoint is progression-free survival (PFS) by investigator assessment per RECIST 1.1.
| # | Form Name | Category | Fields | Required at Visit | Status |
|---|---|---|---|---|---|
| 1 | Demographics | Baseline | 6 | Screening | Complete |
| 2 | Inclusion / Exclusion Criteria | Eligibility | 5 | Screening | Complete |
| 3 | Medical History | Baseline | 4 | Screening | Complete |
| 4 | Prior / Concomitant Medications | Medications | 4 | All Visits | In Progress |
| 5 | Hematology Panel | Lab | 6 | All Cycles | In Progress |
| 6 | Chemistry Panel | Lab | 7 | All Cycles | In Progress |
| 7 | Urinalysis | Lab | 4 | Screening, C3D1 | Complete |
| 8 | Coagulation Panel | Lab | 3 | Screening, C1D1 | Complete |
| 9 | Pregnancy Test | Lab | 2 | Screening | Complete |
| 10 | Vital Signs | Assessments | 5 | All Visits | In Progress |
| 11 | Physical Examination | Assessments | 3 | Screening, C3D1, C7D1 | In Progress |
| 12 | ECG | Assessments | 4 | Screening, C1D1 | Complete |
| 13 | Performance Status (ECOG) | Assessments | 2 | All Cycles | In Progress |
| 14 | Adverse Events | Safety | 4 | All Visits | In Progress |
| 15 | Serious Adverse Events | Safety | 3 | All Visits | Not Started |
| 16 | Efficacy Assessments | Efficacy | 3 | C3D1, C5D1, C7D1 | In Progress |
| 17 | PRO Questionnaires | Efficacy | 3 | All Cycles | In Progress |
| 18 | Drug Dispensation | Drug | 2 | C1D1 – C7D1 | In Progress |
| 19 | Drug Administration | Drug | 3 | C1D1 – C7D1 | In Progress |
| 20 | Compliance | Drug | 2 | All Cycles | In Progress |
| 21 | Study Completion | Admin | 2 | EOS | Not Started |
| 22 | Disposition | Admin | 2 | EOS | Not Started |
Total: 71 fields across 22 forms
| # | Visit Name | Window | Mandatory Forms | Status |
|---|---|---|---|---|
| 1 | Screening | Day -28 to -1 | Demographics, I/E Criteria, Medical History, Labs, ECG, VS | Complete |
| 2 | Treatment Allocation | Day 1 | Randomisation, Drug Dispensation | Complete |
| 3 | Cycle 1 Day 1 | Day 1 ±3 | VS, Hematology, Chemistry, AEs, Drug Admin | Complete |
| 4 | Cycle 2 Day 1 | Day 22 ±3 | VS, Hematology, Chemistry, AEs, PRO, Drug Admin | Complete |
| 5 | Cycle 3 Day 1 | Day 43 ±3 | VS, Phys Exam, Labs, AEs, Efficacy, PRO, Drug Admin | In Progress |
| 6 | Cycle 4 Day 1 | Day 64 ±3 | VS, Hematology, Chemistry, AEs, PRO, Drug Admin | In Progress |
| 7 | Cycle 5 Day 1 | Day 85 ±3 | VS, Labs, Efficacy, AEs, PRO, Drug Admin | Scheduled |
| 8 | Cycle 6 Day 1 | Day 106 ±3 | VS, Hematology, Chemistry, AEs, PRO, Drug Admin | Scheduled |
| 9 | Cycle 7 Day 1 | Day 127 ±3 | VS, Phys Exam, Labs, Efficacy, AEs, PRO, Drug Admin | Scheduled |
| 10 | Cycle 8 Day 1 | Day 148 ±3 | VS, Hematology, Chemistry, AEs, PRO, Drug Admin | Scheduled |
| 11 | Cycle 9 Day 1 | Day 169 ±3 | VS, Labs, AEs, PRO, Drug Admin | Scheduled |
| 12 | Treatment Discontinuation | Within 7d of last dose | VS, Labs, AEs, SAEs, Disposition | Scheduled |
| 13 | 28-Day Follow-up | Day 28 ±7 post-disc | VS, AEs, SAEs, Concomitant Meds | Scheduled |
| 14 | Progression Follow-up | Every 6 weeks | Efficacy, PRO, AEs | Scheduled |
| 15 | Survival Follow-up | Every 12 weeks | Study Completion, Survival Status | Scheduled |
Enrolled Subjects
| Subject ID | Site | Arm | Status | Enrolled | Last Visit | Completion |
|---|---|---|---|---|---|---|
| TEST-001 | Site 001 — London | Osimertinib + Chemo | Active | 2025-01-10 | Cycle 3 Day 1 |
68%
|
Subject TEST-001 — Visit Schedule
| Visit | Date | Forms Completed | Forms Total | Queries | Status |
|---|---|---|---|---|---|
| Screening | 2025-01-10 | 10 | 10 | 0 | Complete |
| Treatment Allocation | 2025-01-17 | 5 | 5 | 0 | Complete |
| Cycle 1 Day 1 | 2025-01-17 | 8 | 8 | 1 | Complete |
| Cycle 2 Day 1 | 2025-02-07 | 7 | 8 | 0 | In Progress |
| Cycle 3 Day 1 | 2025-03-01 | 3 | 10 | 0 | In Progress |
| Cycle 4 Day 1 | — | 0 | 8 | 0 | Scheduled |
Audit Trail — 21 CFR Part 11 Compliant
110 immutable entries · Last updated 2025-03-01 14:32 UTC
| Timestamp (UTC) | Action | Table | Record | Field | Old Value | New Value | User |
|---|---|---|---|---|---|---|---|
| 2025-03-01 14:32:10 | INSERT | form_data | TEST-001 / Demographics | weight_kg | — | 72.4 | system |
| 2025-03-01 14:31:55 | UPDATE | form_data | TEST-001 / Vital Signs | systolic_bp | 118 | 122 | system |
| 2025-03-01 14:30:12 | INSERT | form_data | TEST-001 / Hematology | wbc_10e9_l | — | 6.8 | system |
| 2025-02-28 09:15:44 | INSERT | form_data | TEST-001 / Chemistry | creatinine_umol_l | — | 82.0 | system |
| 2025-02-28 09:14:22 | INSERT | form_data | TEST-001 / Hematology | hemoglobin_g_dl | — | 13.2 | system |
| 2025-02-27 16:44:01 | UPDATE | subjects | TEST-001 | current_visit | Cycle 2 Day 1 | Cycle 3 Day 1 | system |
| 2025-02-15 11:20:33 | INSERT | form_data | TEST-001 / Adverse Events | ae_term | — | Nausea Grade 1 | system |
| 2025-02-15 11:19:50 | INSERT | form_data | TEST-001 / Adverse Events | ae_grade | — | 1 | system |
| 2025-02-14 08:30:11 | INSERT | visit_data | TEST-001 / Cycle 2 Day 1 | visit_date | — | 2025-02-07 | system |
| 2025-02-07 10:05:22 | INSERT | form_data | TEST-001 / PRO Questionnaire | eortc_qlq_c30 | — | 72 | system |
| 2025-02-07 10:03:44 | INSERT | form_data | TEST-001 / Drug Admin | osimertinib_dose_mg | — | 80 | system |
| 2025-01-30 14:18:09 | UPDATE | form_data | TEST-001 / Chemistry | alt_u_l | 28 | 35 | system |
| 2025-01-22 13:55:30 | INSERT | form_data | TEST-001 / ECG | qtcf_ms | — | 412 | system |
| 2025-01-22 13:54:11 | INSERT | form_data | TEST-001 / ECG | pr_interval_ms | — | 164 | system |
| 2025-01-20 09:00:05 | INSERT | form_data | TEST-001 / Performance Status | ecog_score | — | 1 | system |
| 2025-01-17 08:45:22 | INSERT | visit_data | TEST-001 / Cycle 1 Day 1 | visit_date | — | 2025-01-17 | system |
| 2025-01-17 08:44:10 | INSERT | form_data | TEST-001 / Drug Dispensation | lot_number | — | LOT-2024-OSI-0042 | system |
| 2025-01-17 08:43:01 | INSERT | form_data | TEST-001 / Drug Dispensation | quantity_dispensed | — | 28 tablets | system |
| 2025-01-10 11:30:00 | INSERT | subjects | TEST-001 | subject_id | — | TEST-001 | system |
| 2025-01-10 11:29:44 | INSERT | form_data | TEST-001 / Demographics | date_of_birth | — | 1968-04-15 | system |
Showing 20 of 110 entries. All records are immutable per 21 CFR Part 11 / ICH E6(R3).
Export Study Data
Excel / XLSX
Full dataset with separate sheets per form. Compatible with SAS, R, and SPSS.
CSV Export
Flat CSV files per form — one row per subject per visit.
CDISC ODM-XML
FDA-compliant ODM export for SDTM / regulatory submissions.
Audit Trail PDF
Full 110-entry immutable audit log — 21 CFR Part 11 compliant PDF.
SAS Transport (XPT)
SAS dataset files ready for FDA NDA/BLA submission.
JSON Export
Full study JSON including schema, data and audit trail.
Data Preview — Hematology Panel (TEST-001)
| Visit | WBC (×10⁹/L) | RBC (×10¹²/L) | Hgb (g/dL) | Hct (%) | Platelets (×10⁹/L) | Neutrophils (%) |
|---|---|---|---|---|---|---|
| Screening | 7.2 | 4.55 | 13.8 | 41.2 | 224 | 62.4 |
| Cycle 1 Day 1 | 6.8 | 4.48 | 13.2 | 40.1 | 198 | 58.7 |
| Cycle 2 Day 1 | 5.9 | 4.31 | 12.8 | 38.6 | 176 | 54.1 |
| Cycle 3 Day 1 | 6.1 | 4.38 | 13.0 | 39.2 | 189 | 56.3 |