Cycle 1 · Activities
Patient study milestones — select a step to open its sheet
Screening05-Jul-2026
C1D119-Jul-2026Active
C1D826-Jul-2026
C1D1502-Aug-2026
Cycle 2 · RECIST16-Aug-2026
Safety Labs · Pre-dose Validation
Hematology & chemistry · CTCAE v5.0 grading
Automated Safety Flag — Grade 2 Neutropenia CTCAE Grade 2
ANC 1.1 K/µL is below the protocol dosing threshold (≥ 1.5 K/µL) required for C1D1 administration. Protocol PS-2041 §6.3 requires a dose modification or dosing delay before study drug is given. Investigator decision required.
| Parameter | Result | Units | Reference | CTCAE | Status |
|---|---|---|---|---|---|
| Hemoglobin | 12.8 | g/dL | 12.0–16.0 | — | Within range |
| WBC | 4.6 | K/µL | 4.0–11.0 | — | Within range |
| ANC (Absolute Neutrophil Count) | 1.1 | K/µL | 1.5–8.0 | G2 | Below threshold |
| Platelets | 176 | K/µL | 150–400 | — | Within range |
| Creatinine | 0.9 | mg/dL | 0.6–1.3 | — | Within range |
| ALT | 28 | U/L | 7–56 | — | Within range |
Investigator clinical decision
Record the rationale for managing the Grade 2 neutropenia per protocol §6.3.
Decision recorded:
eCOA · Clinical Outcome Assessments
Point-of-care performance status & patient-reported outcomes
ECOG Performance Status clinician-rated
0Grade 0Fully active, no restriction
1Grade 1Ambulatory, light work restriction
2Grade 2Ambulatory, self-care, no work
Patient Symptom Tracker logged on tablet
FatigueGr 1 · Mild
DyspneaGr 1 · Mild
NauseaGr 0 · None
NeuropathyGr 1 · Mild
Patient Sign-Off validatedSubject 2041-0017 · signed on tablet 07:52 EDT
Cryptographic
e-signature ✓
e-signature ✓
Infusion & Serial PK Protocol
Study drug administration & pharmacokinetic sampling
Infusion Tracking PS-2041 study drug · 40 mg/m²
Infusion start19-Jul 10:05:12
Infusion stop19-Jul 11:35:40
Duration90 min 28 s
Rate250 mL/hr
Administered byRN M. Alvarez
Serial PK Draws relative to infusion end
Pre-doseCollected 09:50:04 · aliquot A-01 loggedCompleted
1 h post-infusionCollected 12:35:22 · aliquot A-02 loggedCompleted
2 h post-infusionScheduled window 13:35 (± 10 min)Due in 14 min
Next draw window opens at 13:35 EDT — the nurse is alerted automatically.
Audit Trail & Electronic Signature
21 CFR Part 11 · attributable, time-stamped, tamper-evident
Immutable Audit Ledger every action recorded
audit-stream · subject 2041-0017 · C1D1
Investigator Sign-Off secure credentials
Record electronically signed