﻿# HAD Digital - CTCAE Term Prioritization

**Version:** 1.0.0  
**Date:** 5 September 2026  
**Clinical Owner:** Dr Kais Aldabbagh, Polyclinique St Come - Medical Oncology

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## Overview

This document defines the prioritized subset of CTCAE v5.0 terms for the MVP. These terms are clinically relevant to the patient population treated in HAD (Hospitalisation a Domicile) and are implemented in the toxicity grading engine.

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## Prioritization Criteria

1. **Clinical relevance:** Terms relevant to chemotherapy toxicity in HAD patients
2. **Frequency:** Commonly observed adverse events in home-care settings
3. **Actionability:** Terms that require clinical intervention when grade >= 2
4. **Patient reportability:** Terms that patients can self-report reliably
5. **Clinician observability:** Terms that can be assessed during home visits

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## Domain 1: Gastrointestinal

| CTCAE Term | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Priority |
|------------|---------|---------|---------|---------|----------|
| Nausea | Loss of appetite without alteration in eating habits | Decreased oral intake without significant weight loss, dehydration, or malnutrition | Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated | Life-threatening consequences; urgent intervention indicated | HIGH |
| Vomiting | 1-2 episodes per 24 hrs | 3-5 episodes per 24 hrs; IV fluids indicated | >= 6 episodes per 24 hrs; tube feeding, TPN, or hospitalization indicated | Life-threatening consequences; urgent intervention indicated | HIGH |
| Diarrhea | Increase of <4 stools per day over baseline | Increase of 4-6 stools per day over baseline; IV fluids indicated | Increase of >= 7 stools per day over baseline; incontinence; hospitalization indicated | Life-threatening consequences; urgent intervention indicated | HIGH |
| Stomatitis | Erythema of the mucosa | Patchy ulcerations or pseudomats; can eat solids | Confluent ulcerations; cannot eat solids; tube feeding indicated | Life-threatening consequences; urgent intervention indicated | MEDIUM |
| Constipation | Occasional or intermittent symptoms | Persistent symptoms with regular use of laxatives indicated | Symptoms requiring manual evacuation; hospitalization indicated | Life-threatening consequences; urgent intervention indicated | MEDIUM |

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## Domain 2: Hematologic

| CTCAE Term | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Priority |
|------------|---------|---------|---------|---------|----------|
| Anemia | Hemoglobin <LLN - 10.0 g/dL | Hemoglobin <10.0 - 8.0 g/dL | Hemoglobin <8.0 g/dL; transfusion indicated | Life-threatening consequences; urgent intervention indicated | HIGH |
| Neutrophil count decreased | <LLN - 1500/mm3 | <1500 - 1000/mm3 | <1000 - 500/mm3 | <500/mm3 | HIGH |
| Platelet count decreased | <LLN - 75,000/mm3 | <75,000 - 50,000/mm3 | <50,000 - 25,000/mm3 | <25,000/mm3 | HIGH |
| Febrile neutropenia | N/A | N/A | ANC <1000/mm3 with a single temperature >38.3C or sustained temperature >=38C for more than one hour | Life-threatening consequences; urgent intervention indicated | HIGH |
| White blood cell decreased | <LLN - 3000/mm3 | <3000 - 2000/mm3 | <2000 - 1000/mm3 | <1000/mm3 | MEDIUM |

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## Domain 3: Dermatologic

| CTCAE Term | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Priority |
|------------|---------|---------|---------|---------|----------|
| Rash maculo-papular | Macules/papules covering <10% BSA with or without symptoms | Macules/papules covering 10-30% BSA with or without symptoms; limiting instrumental ADL | Macules/papules covering >30% BSA with or without symptoms; limiting self-care ADL | N/A | MEDIUM |
| Palmar-plantar erythrodysesthesia syndrome | Minimal skin changes or dermatitis without pain | Skin changes with pain; limiting instrumental ADL | Severe skin changes with pain; limiting self-care ADL | N/A | MEDIUM |
| Alopecia | Thinning or patchy hair loss | Complete hair loss | N/A | N/A | LOW |
| Pruritus | Mild or localized | Intense or widespread; limiting instrumental ADL | Intense or widespread; limiting self-care ADL | N/A | LOW |
| Dry skin | covering <10% BSA without erythema | covering 10-30% BSA with erythema | covering >30% BSA with erythema | N/A | LOW |

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## Domain 4: Neurologic

| CTCAE Term | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Priority |
|------------|---------|---------|---------|---------|----------|
| Peripheral sensory neuropathy | Mild paresthesia | Moderate paresis; limiting instrumental ADL | Severe paresthesias; limiting self-care ADL | Life-threatening consequences; urgent intervention indicated | HIGH |
| Peripheral motor neuropathy | Mild weakness | Moderate weakness; limiting instrumental ADL | Severe weakness; limiting self-care ADL | Life-threatening consequences; urgent intervention indicated | HIGH |
| Headache | Mild pain | Moderate pain; limiting instrumental ADL | Severe pain; limiting self-care ADL | N/A | MEDIUM |
| Dizziness | Mild, intermittent | Moderate, persistent | Severe; limiting self-care ADL | N/A | LOW |
| Dysgeusia | Altered taste but no change in diet | Altered taste with change in diet; no nutritional support needed | N/A | N/A | LOW |

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## Domain 5: Constitutional

| CTCAE Term | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Priority |
|------------|---------|---------|---------|---------|----------|
| Fatigue | Mild fatigue over baseline | Moderate fatigue; limiting instrumental ADL | Severe fatigue; limiting self-care ADL | N/A | HIGH |
| Fever | 38.0-39.0C | 39.0-40.0C | >40.0C for <=24 hrs | >40.0C for >24 hrs | HIGH |
| Weight loss | 5-10% from baseline | 10-20% from baseline | >20% from baseline; tube feeding indicated | N/A | MEDIUM |
| Anorexia | Loss of appetite without alteration in eating habits | Decreased oral intake without significant weight loss | Inadequate oral caloric or fluid intake | Life-threatening consequences | MEDIUM |
| Chills | Mild; no intervention indicated | Moderate; intervention indicated | N/A | N/A | LOW |

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## Domain 6: Metabolic

| CTCAE Term | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Priority |
|------------|---------|---------|---------|---------|----------|
| Hyperglycemia | Fasting glucose >ULN - 160 mg/dL | Fasting glucose >160 - 250 mg/dL | Fasting glucose >250 - 500 mg/dL | Fasting glucose >500 mg/dL | MEDIUM |
| Hypokalemia | <LLN - 3.0 mEq/L | <3.0 - 2.5 mEq/L | <2.5 mEq/L; hospitalization indicated | Life-threatening consequences | MEDIUM |
| Hypomagnesemia | <LLN - 1.2 mg/dL | <1.2 - 0.9 mg/dL | <0.9 mg/dL; hospitalization indicated | Life-threatening consequences | MEDIUM |
| Hypocalcemia | <LLN - 8.0 mg/dL | <8.0 - 7.0 mg/dL | <7.0 mg/dL; hospitalization indicated | Life-threatening consequences | MEDIUM |

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## Domain 7: Hepatobiliary

| CTCAE Term | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Priority |
|------------|---------|---------|---------|---------|----------|
| ALT increased | >ULN - 3.0 x ULN | >3.0 - 5.0 x ULN | >5.0 - 20.0 x ULN | >20.0 x ULN | MEDIUM |
| AST increased | >ULN - 3.0 x ULN | >3.0 - 5.0 x ULN | >5.0 - 20.0 x ULN | >20.0 x ULN | MEDIUM |
| Bilirubin increased | >ULN - 1.5 x ULN | >1.5 - 3.0 x ULN | >3.0 - 10.0 x ULN | >10.0 x ULN | MEDIUM |

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## Domain 8: Renal

| CTCAE Term | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Priority |
|------------|---------|---------|---------|---------|----------|
| Creatinine increased | >ULN - 1.5 x baseline | >1.5 - 3.0 x baseline | >3.0 - 6.0 x baseline; hospitalization indicated | >6.0 x baseline; dialysis indicated | MEDIUM |
| Proteinuria | 1+ or 0.15-1.0 g/24 hrs | 2+ or 1.0-3.5 g/24 hrs | 3+ or >3.5 g/24 hrs | N/A | LOW |

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## Summary: MVP Priority Terms

### HIGH Priority (Implemented in MVP)

| # | Term | Domain | Patient Reportable | Clinician Observable |
|---|------|--------|-------------------|---------------------|
| 1 | Nausea | Gastrointestinal | ✓ | ✓ |
| 2 | Vomiting | Gastrointestinal | ✓ | ✓ |
| 3 | Diarrhea | Gastrointestinal | ✓ | ✓ |
| 4 | Fatigue | Constitutional | ✓ | ✓ |
| 5 | Fever | Constitutional | ✓ | ✓ |
| 6 | Peripheral sensory neuropathy | Neurologic | ✓ | ✓ |
| 7 | Peripheral motor neuropathy | Neurologic | ✓ | ✓ |
| 8 | Anemia | Hematologic | ✓ | ✓ |
| 9 | Neutrophil count decreased | Hematologic | ✗ | ✓ |
| 10 | Platelet count decreased | Hematologic | ✗ | ✓ |
| 11 | Febrile neutropenia | Hematologic | ✓ | ✓ |

### MEDIUM Priority (Partial implementation in MVP)

| # | Term | Domain | Patient Reportable | Clinician Observable |
|---|------|--------|-------------------|---------------------|
| 12 | Stomatitis | Gastrointestinal | ✓ | ✓ |
| 13 | Constipation | Gastrointestinal | ✓ | ✓ |
| 14 | Rash maculo-papular | Dermatologic | ✓ | ✓ |
| 15 | Palmar-plantar erythrodysesthesia | Dermatologic | ✓ | ✓ |
| 16 | Headache | Neurologic | ✓ | ✓ |
| 17 | Weight loss | Constitutional | ✓ | ✓ |
| 18 | Anorexia | Constitutional | ✓ | ✓ |
| 19 | Hyperglycemia | Metabolic | ✗ | ✓ |
| 20 | Hypokalemia | Metabolic | ✗ | ✓ |
| 21 | ALT increased | Hepatobiliary | ✗ | ✓ |
| 22 | AST increased | Hepatobiliary | ✗ | ✓ |
| 23 | Creatinine increased | Renal | ✗ | ✓ |

### LOW Priority (Not implemented in MVP)

| # | Term | Domain | Patient Reportable | Clinician Observable |
|---|------|--------|-------------------|---------------------|
| 24 | Alopecia | Dermatologic | ✓ | ✓ |
| 25 | Pruritus | Dermatologic | ✓ | ✓ |
| 26 | Dry skin | Dermatologic | ✓ | ✓ |
| 27 | Dizziness | Neurologic | ✓ | ✓ |
| 28 | Dysgeusia | Neurologic | ✓ | ✓ |
| 29 | Chills | Constitutional | ✓ | ✓ |
| 30 | Hypomagnesemia | Metabolic | ✗ | ✓ |
| 31 | Hypocalcemia | Metabolic | ✗ | ✓ |
| 32 | Bilirubin increased | Hepatobiliary | ✗ | ✓ |
| 33 | Proteinuria | Renal | ✗ | ✓ |

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## Implementation Notes

### MVP Implementation

The MVP implements 12 HIGH-priority terms with 5 symptom domains:

1. **Gastrointestinal:** Nausea, Vomiting, Diarrhea (3 terms)
2. **Hematologic:** Fatigue, Bleeding/Bruising, Signs of Infection (3 terms)
3. **Dermatologic:** Rash, Skin Changes (2 terms)
4. **Neurologic:** Numbness/Tingling, Muscle Weakness (2 terms)
5. **Constitutional:** Fever, Weight Loss (2 terms)

### Grading Logic

The MVP uses a simplified grading logic:

1. **Patient reports symptom severity** (0-3 scale)
2. **Engine maps to CTCAE grade** (1-5 scale)
3. **Grade >= 2 flagged provisional** until clinician confirms
4. **Alert triggered** based on grade and symptom

### Future Enhancements

1. **Full CTCAE v5.0 implementation:** All 790+ terms
2. **Physician-configurable terms:** Per-patient term selection
3. **Lab value integration:** Automated grading from lab results
4. **Context-aware grading:** Adjust for patient baseline
5. **Machine learning:** Predictive risk scoring

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## References

- CTCAE v5.0 (November 27, 2017)
- U.S. Department of Health and Human Services
- National Institutes of Health
- National Cancer Institute
