Adverse Event/Toxicity Assessment Note (Pediatric Oncology)

Date/Time: [Encounter date and time]

Location: [Clinic / Infusion center / ED / Inpatient / Telehealth]

Patient: [Patient full name]

DOB: [Date of birth]

Diagnosis: [Primary oncology diagnosis]

Protocol/Regimen: [Protocol name/number or regimen]

Cycle/Day: [Cycle and day]

Last Treatment Date: [Date]

Source of History: [Patient / Caregiver / Patient and Caregiver / Medical record] (Note interpreter use and language if applicable.)

Chief Concern

[Brief reason for visit or protocol-driven toxicity check] (Use patient/caregiver wording when symptom-driven; one to two sentences maximum.)

Interval History

[Focused narrative on the clinical trigger and toxicity-relevant details] (Include symptom timeline, severity, functional impact, fever/infectious symptoms, hydration/nutrition tolerance, pain control, adherence concerns, and any hospital/ED visits since last contact. Include relevant negatives only when they justify proceeding with therapy. Do not include a full ROS unless protocol-mandated.)

Adverse Events/Toxicity Assessment

(List each adverse event since last assessment. Use standardized AE terms. Do not infer attribution without documented reasoning. Do not mark events as resolved unless explicitly confirmed.)

• AE term: [Standardized adverse event term]

  Grade (CTCAE): [1 / 2 / 3 / 4 / 5] — [Brief supporting evidence: symptom descriptor or lab value with date]

  Attribution: [Unrelated / Unlikely / Possible / Probable / Definite] (Include when on protocol or trial; provide brief rationale.)

  Onset/Status: [Onset date] — [resolved / ongoing / improving / worsening]

  Action taken: [Supportive care / Dose held / Dose modified / Hospitalization / Transfusion / Other]

  Trial reporting (if applicable): [SAE criteria: Yes/No] • [Expected / Unexpected] • [Reporting status]

• (Repeat AE block as needed.)

(If no new adverse events, state explicitly: "No new adverse events identified." Note monitoring reviewed that supports proceeding.)

Objective

Vitals/Growth: [Temp, HR, RR, BP, SpO2, weight, pain score as relevant]

Performance Status: [Lansky/Karnofsky score if used]

Exam: [Pertinent focused findings relevant to current AEs] (If exam limited, document reason.)

Labs/Diagnostics: [Key results with collection date; note trends; list pending studies]

Assessment and Plan

(Problem-oriented, ordered by severity. For each toxicity problem: current status with grade, supporting evidence, differential if uncertain, and explicit decision.)

[Problem: AE or clinical issue]

[Assessment summary with CTCAE grade if applicable; key data and clinical reasoning]

Decision: [Proceed / Delay / Hold / Modify / Escalate] — [Rationale tied to grade and protocol thresholds]

Supportive care: [Interventions, monitoring plan, thresholds for action]

Dose modification: [Original dose/schedule] → [New dose/schedule or hold]; [Protocol-specified / Clinician judgment] (Include only if dose change made.)

(Repeat problem blocks as needed.)

Protocol eligibility: [Meets / Does not meet criteria for therapy continuation] (Reference protocol thresholds. If required information is missing, state what is pending and whether therapy is held.)

Return Precautions

[Individualized safety instructions provided] (Document specific precautions discussed: fever threshold, bleeding, dehydration, respiratory or neurologic changes, line concerns. Note contact pathways: clinic, after-hours, ED. Document who received instructions and interpreter use if applicable.)

Follow-up

Next visit: [Timing and location]

Pending: [Labs, diagnostics, results to review, referrals as applicable]