TABLE 3.
Variation in AE grading between CTC versions for the case vignette
| Symptom in clinical summary | AE identified by comprehensive AE assessment approach (per CTCAEv4.0) | Grade | |||
|---|---|---|---|---|---|
| CTCv1.0 | CTCv2.0 | CTCAEv3.0 | CTCAEv4.0 | ||
| Pain due to frequent bowel movements | Buttock pain | - | - | NG | NG |
| Rectal pain | - | NG | NG | NG | |
| Anal pain | - | - | NG | NG | |
| Diarrhea | Diarrheaa | 3 | 3 | 3 | 3 |
| Fecal incontinence | NG | NG | 3 | ||
| Proctitis | - | 3 | 3 | 3 | |
| Mucositis | Anal mucositis | - | - | 3b | NG |
| Rectal mucositis | - | - | 3c | NG | |
| Colitis | Colitisa | - | 3 | 3 | 3 |
| Enterocolitis | - | - | 3d | 3 | |
| Typhlitis | Typhlitis | - | 3 | 3 | 3 |
| Abdominal pain | Abdominal pain | - | NG | NGe | NG |
| Stomach pain | - | - | - | NG | |
| Loss of appetite/TPN requirement | Weight lossa | 2f | 1 | 3 | 3 |
| Anorexiaa | 3 | 4 | 3 | 3 | |
| Malabsorption | - | - | 3 | 3 | |
| Nauseaa | 3 | 2 | 3 | 3 | |
| Vomitinga | 4 | 4 | 3 | 3 | |
| Cardiac symptoms | Ejection fraction decreaseda | - | - | - | 3 |
| Heart failure | - | - | - | 4 | |
| Left ventricular systolic dysfunctiona | 3g | NGh | 3 | 4 | |
| Left ventricular diastolic dysfunction | - | - | 3 | - | |
| Respiratory symptoms | Dyspneaa | 4i | 4 | 4 | 4 |
| Cougha | - | NG | NG | 2 | |
| Hemoptysis | - | 3 | - | - | |
| Productive cough | - | - | - | NG | |
| Sore throat | - | - | - | NG | |
| Laryngeal hemorrhage | - | 3j | 3k | 3 | |
| Tracheal mucositisa | - | - | - | 1 | |
| Postnasaldrip | - | - | - | 2 | |
| Wheezing | - | - | NG | 2 | |
| Atelectasis | - | - | 4 | 4 | |
| Respiratory failure | - | - | - | 4 | |
| Adult respiratory distress syndrome | 4 | 4 | 4 | ||
| Sinus tachycardiaa | 4l | 3 | 4 | 3 | |
| Low blood pressure | Hypotensiona | 4 | 3 | NG | 4 |
| Infection | Catheter-related infectiona | 4m | 4 | 4 | 4 |
| Sepsis | Sepsisa | - | - | - | 4 |
| Elevated temperature | Fever | - | - | 1 | 1 |
| Total number of AEs unable to be graded | 0 | 5 | 8 | 9 | |
Notes: Green, consistent grading of AE across CTC versions; red, inconsistent grading of AE across CTC versions; NG, AE unable to be graded definitively; -, AE not in CTC version.
Approach 2 also identified stomatitis in CTC v1.0, stomatitis, infection, and hypoxia in CTC v2.0, infection in CTCAE v3.0 and hypoxia and febrile neutropenia in CTCAE v4.0, which were not identified by approach 1 in those versions.
AE also identified by approach 2 (in at least one of the CTC versions).
In CTCAEv3.0, anal mucositis is called “mucositis/stomatitis (functional/symptomatic)–Anus.”
In CTCAEv3.0, rectal mucositis is called “mucositis/stomatitis (functional/symptomatic)–Rectum.”
In CTCAEv3.0, enterocolitis is called “enteritis.”
In CTCAEv3.0, abdominal pain is called “pain abdomen NOS.”
In CTCAEv1.0, weight loss is called “weight gain/loss.”
In CTCAEv1.0, left ventricular systolic dysfunction is called “cardiac function.”
In CTCAEv2.0, left ventricular systolic dysfunction is called “cardiac left ventricular function.”
In CTCAEv1.0, dyspnea is called “pulmonary.”
In CTCAEv3.0, laryngeal hemorrhage is called “hemorrhage, pulmonary/upper respiratory—bronchopulmonary NOS.”
In CTCAEv2.0, laryngeal hemorrhage is called “hemorrhage/bleeding with grade 3 or 4 thrombocytopenia.”
In CTCAEv1.0, sinus tachycardia is called “dysrhythmias.”
In CTCAEv1.0, catheter-related infection is called “infection.”