Forms
9
Visits
7
Fields
33
Subjects
1
Audit Events
42
Completion
54%
Study Information
| Study ID | 39d16fdf-7851-448a-8f23-d46757476647 |
| Short Name | PLANETTE |
| Phase | Phase II |
| Status | Active |
| Design | Open-label, multicentre |
| Indication | Advanced solid tumours |
| Intervention | Platinum-based chemotherapy |
| Created | 2025-01-08 |
Completion by Visit
Safety Summary
Adverse Events Reported3 events
Grade 1–23 (100%)
Grade 3–40
SAEs0
Study Description
PLANETTE is a multicentre, open-label Phase II study evaluating treatment response and tolerability of platinum-based chemotherapy regimens in patients with advanced solid tumours. The study assesses objective response rate (ORR) as the primary endpoint, with disease control rate (DCR), progression-free survival (PFS), and safety profile as secondary endpoints.
| # | Form Name | Fields | Required at Visit | Status |
|---|---|---|---|---|
| 1 | Demographics | 5 | Screening | Complete |
| 2 | Inclusion / Exclusion Criteria | 4 | Screening | Complete |
| 3 | Medical History | 3 | Screening | Complete |
| 4 | Concomitant Medications | 3 | All Visits | In Progress |
| 5 | Vital Signs | 4 | All Visits | In Progress |
| 6 | Physical Examination | 3 | Screening, C2D1, EoT | In Progress |
| 7 | Laboratory Tests | 5 | Screening, C1D1, C2D1 | In Progress |
| 8 | Adverse Events | 4 | All Visits | In Progress |
| 9 | Study Completion | 2 | EoT | Not Started |
Total: 33 fields across 9 forms
| # | Visit Name | Window | Key Forms | Status |
|---|---|---|---|---|
| 1 | Screening | Day -21 to -1 | Demographics, I/E, Medical History, Labs, VS | Complete |
| 2 | Baseline | Day 1 | VS, Physical Exam, Labs | Complete |
| 3 | Cycle 1 Day 1 | Day 1 ±2 | VS, Labs, AEs, Concomitant Meds | Complete |
| 4 | Cycle 1 Day 15 | Day 15 ±2 | VS, AEs, Concomitant Meds | In Progress |
| 5 | Cycle 2 Day 1 | Day 22 ±2 | VS, Physical Exam, Labs, AEs | In Progress |
| 6 | End of Treatment | Within 7d of last dose | VS, Physical Exam, Labs, AEs, Study Completion | Scheduled |
| 7 | Follow-up | 30 days post-EoT | VS, AEs, Concomitant Meds | Scheduled |
| Subject ID | Site | Status | Enrolled | Last Visit | Completion |
|---|---|---|---|---|---|
| TEST-001 | Site 001 — Paris | Active | 2025-01-08 | Cycle 1 Day 15 | 54% |
Subject TEST-001 — Visit Schedule
| Visit | Date | Forms Done | Forms Total | Status |
|---|---|---|---|---|
| Screening | 2025-01-08 | 5 | 5 | Complete |
| Baseline | 2025-01-15 | 3 | 3 | Complete |
| Cycle 1 Day 1 | 2025-01-15 | 4 | 4 | Complete |
| Cycle 1 Day 15 | 2025-01-29 | 2 | 3 | In Progress |
| Cycle 2 Day 1 | 2025-02-05 | 1 | 5 | In Progress |
| End of Treatment | — | 0 | 5 | Scheduled |
| Follow-up | — | 0 | 3 | Scheduled |
Audit Trail — 21 CFR Part 11 Compliant
42 immutable entries · Last updated 2025-02-05
| Timestamp (UTC) | Action | Table | Record | Field | Old Value | New Value | User |
|---|---|---|---|---|---|---|---|
| 2025-02-05 10:22:14 | INSERT | form_data | TEST-001 / Laboratory Tests | alt_u_l | — | 32 | system |
| 2025-02-05 10:21:08 | INSERT | form_data | TEST-001 / Vital Signs | systolic_bp | — | 126 | system |
| 2025-02-05 10:20:44 | UPDATE | subjects | TEST-001 | current_visit | Cycle 1 Day 15 | Cycle 2 Day 1 | system |
| 2025-01-29 14:15:30 | INSERT | form_data | TEST-001 / Adverse Events | ae_term | — | Fatigue Grade 1 | system |
| 2025-01-29 14:14:20 | INSERT | visit_data | TEST-001 / Cycle 1 Day 15 | visit_date | — | 2025-01-29 | system |
| 2025-01-29 14:13:05 | INSERT | form_data | TEST-001 / Concomitant Meds | drug_name | — | Ondansetron 8mg | system |
| 2025-01-15 09:30:00 | INSERT | form_data | TEST-001 / Laboratory Tests | wbc_10e9_l | — | 6.2 | system |
| 2025-01-15 09:28:44 | INSERT | visit_data | TEST-001 / Cycle 1 Day 1 | visit_date | — | 2025-01-15 | system |
| 2025-01-15 09:27:11 | INSERT | form_data | TEST-001 / Vital Signs | heart_rate | — | 74 | system |
| 2025-01-08 11:05:22 | INSERT | subjects | TEST-001 | subject_id | — | TEST-001 | system |
| 2025-01-08 11:04:10 | INSERT | form_data | TEST-001 / Demographics | date_of_birth | — | 1972-09-22 | system |
| 2025-01-08 11:03:55 | INSERT | form_data | TEST-001 / Demographics | sex | — | Female | system |
| 2025-01-08 11:03:40 | INSERT | form_data | TEST-001 / I/E Criteria | ie_001 | — | Yes | system |
| 2025-01-08 11:03:25 | INSERT | form_data | TEST-001 / Medical History | condition_name | — | Ovarian carcinoma | system |
Showing 14 of 42 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.
CSV Export
Flat CSV files per form.
CDISC ODM-XML
FDA-compliant ODM for regulatory submissions.
Audit Trail PDF
Full 42-entry immutable audit log PDF.
SAS Transport (XPT)
SAS dataset files for submission.
JSON Export
Full study JSON with audit trail.
Data Preview — Laboratory Tests (TEST-001)
| Visit | WBC (×10⁹/L) | Hgb (g/dL) | Platelets (×10⁹/L) | ALT (U/L) | Creatinine (μmol/L) |
|---|---|---|---|---|---|
| Screening | 6.2 | 12.9 | 215 | 28 | 74 |
| Cycle 1 Day 1 | 6.2 | 12.5 | 208 | 30 | 76 |
| Cycle 2 Day 1 | 5.8 | 11.8 | 192 | 32 | 79 |