Table 2.

Examples of new grading criteria developed to supplement CTCAE v4.03

ConditionRationale for addition/changeNew grading criteriaGrading source
AmputationCTCAE does not include this adverse event.
  1. Partial ostectomy or other bone repair

  2. Amputation below ankle or below elbow/revision of amputation

  3. Total ostectomy/upper extremity amputation above elbow or higher/lower extremity amputation above ankle or higher

  4. Not applicable

  5. Not applicable

ICD-9-CM diagnosis and procedure codes
Bone mineral density deficitCTCAE does not have pediatric-specific criteria for bone mineral density deficits.
  1. Radiologic evidence of low BMD with z-score of ≤−2.0 and no history of significant fractures

  2. Low BMD (z-score ≤−2.0) and significant fracture history (defined as a long bone fracture of the lower extremity, vertebral compression, 2 or more long bone fracture of the upper extremities); therapy to improve BMD indicated or initiated

  3. Limiting self-care ADL

  4. Not applicable

  5. Not applicable

International Society of Clinical Densitometry
Overweight ObesityCTCAE categories do not provide pediatric-specific reference ranges.

For age 2–<20 years

  1. Not applicable

  2. BMI ≥85th percentile <95th percentile

  3. BMI ≥95th percentile

  4. Not applicable

  5. Not applicable

Centers for Disease Control and Prevention
SeizuresCTCAE categories are more appropriate for acute event versus chronic seizure disorder/epilepsy.
  1. Seizures not requiring medication

  2. Seizures requiring 1 non-PRN medication

  3. Seizures requiring 2 or more non-PRN medications; poorly controlled seizures with prescribed medications

  4. Seizures requiring evaluation for surgical intervention

  5. Death

Multidisciplinary team consensus
Executive function deficitCTCAE does not include this adverse event.
  1. Performance on a task is >1 but <2 SD below the mean and no functional impairment

  2. Performance on a task is >2 but <3 SD below the mean or performance on a task is >1 but <2 SD below the mean and functional impact on instrumental activities. Examples include, but are not limited to, special education services at school (IEP, 504 plan, not self-contained), unable to reach educational/occupational goals secondary to cognitive impairment, assistance needed completing tasks at home, scheduling/attending appointments

  3. Performance on a task is >3 SD below the mean or performance on a task is >1 but <3 SD below the mean and functional impact in self-care activities. Examples include, but are not limited to, unable to live independently, unable to work, self-contained classroom

  4. Not applicable

  5. Not applicable

Performance on neuropsychologic testing of executive functions, including measures of cognitive flexibility/shifting, verbal fluency/initiation, working memory, and self-monitoring
Posttraumatic stressaCTCAE does not include this adverse event.
  1. Meet criterion for >2 but <4 PTSD symptom clusters (intrusion, avoidance, cognition and mood, arousal and reactivity); mental health intervention not indicated

  2. One cluster B symptom (intrusion) rated as “moderately” or higher, 2 cluster C symptoms (avoidance) rated as “moderately” or higher, 2 cluster D symptoms (cognition and mood) rated as “moderately” or higher, 2 cluster E symptoms (arousal and reactivity) rated as “moderately” or higher and treatment limited to 1 initiated or indicated mental health intervention; symptoms interfere with social or occupational functioning

  3. One cluster B symptom (avoidance) rated as “moderately” or higher, 2 cluster C symptoms (avoidance) rated as “moderately” or higher, 2 cluster D symptoms (cognition and mood) rated as “moderately” or higher, 2 cluster E symptoms (arousal and reactivity) rated as “moderately” or higher and >1 mental health intervention initiated or indicated; symptoms interfere with self-care

  4. Hospitalization indicated due to extreme symptoms of posttraumatic stress

  5. Death

Validated patient reported outcome measure. Threshold of clinical intervention and impact on ADL
  • Abbreviation: ADL, activities of daily living; BMI, body mass index; PTSD, posttraumatic stress disorder.

  • aAll grades require exposure to a traumatic event.