Search 34 frequently graded adverse event terms, from neutrophil count decreased to diarrhea, and read the Grade 1 to 5 criteria exactly as NCI publishes them. Switch to CTCAE v6.0 to see what changed.
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Adverse event term
AETERMOnset date
AESTDTCCTCAE grade
AETOXGRANC 0.8 x 10^9/L
Serious
AESERCTCAE grading in brief
Free tool
Pick the version, search by term or a familiar name (ANC, ALT, anaemia, low platelets) and select a term to see its grade criteria and navigational note. Nothing is saved or sent.
| Grade 1 | <LLN - 1500/mm3; <LLN - 1.5 x 10e9 /L |
|---|---|
| Grade 2 | <1500 - 1000/mm3; <1.5 - 1.0 x 10e9 /L |
| Grade 3 | <1000 - 500/mm3; <1.0 - 0.5 x 10e9 /L |
| Grade 4 | <500/mm3; <0.5 x 10e9 /L |
| Grade 5 | – (grade not available) |
Source: NCI CTCAE v5.0, published 27 November 2017 (ctcae-v5.0.xlsx, dctd.cancer.gov).
*Instrumental ADL: preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc. **Self care ADL: bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. A semicolon means “or” within a grade; a dash means the grade is not available for that term. LLN and ULN are the lower and upper limits of normal.
Reference only: 34 common terms, not the full CTCAE, and not validated software. Use the version your protocol names. Grading, seriousness and causality are the investigator's clinical judgement; always check the official NCI document.
Which version
The Common Terminology Criteria for Adverse Events are published by the US National Cancer Institute. Version 5.0 was published on 27 November 2017 and uses MedDRA 20.1 terms. Version 6.0 was released in 2025, uses MedDRA 28.0, and is distributed as an Excel workbook on the NCI Division of Cancer Treatment and Diagnosis website, with a tab mapping every v5.0 term and grade to v6.0. An errata update dated 20 January 2026 corrected a handful of entries; the tool includes those corrections.
NCI's v6.0 implementation FAQ (September 2025) says v6.0 is ready for immediate use in any study except NCI CTEP and DCP studies, which move to it on NCI's own timetable for newly built studies, and that CTEP and DCP studies reporting in v5.0 continue in v5.0 for the life of the study. The same FAQ says v6.0 is final and that v7.0 is expected between 2027 and 2030. In practice, many ongoing oncology protocols still name v5.0, which is why the lookup defaults to it. Grade with the version your protocol specifies, and do not mix versions within one study without a documented plan.
What changed
Taken from the two NCI workbooks. Use the tool for the full criteria.
| Term (v5.0) | CTCAE v5.0 | CTCAE v6.0 |
|---|---|---|
| Neutrophil count decreased | Grade 1 starts below LLN; Grade 4 is <0.5 x 10e9/L | Grade 1 is <1.5 to 1.0; Grade 3 is <0.5 to 0.1; Grade 4 is <0.1 x 10^9/L |
| Platelet count decreased | Investigations term; Grade 3 <50.0 to 25.0, Grade 4 <25.0 x 10e9/L | Renamed Thrombocytopenia (blood and lymphatic system); Grade 3 <50.0 to 10.0 with transfusion, Grade 4 <10.0, Grade 5 added |
| Lymphocyte count decreased | Graded by count, Grades 1 to 4 | Replaced by Lymphopenia with Grade 1 "Present" only |
| ALT, AST increased | Abnormal baseline: 1.5 to 3.0 x baseline is Grade 1 | Baseline above ULN: 1.0 to 1.5 x baseline is Grade 1, with tighter steps after that |
| Hyperglycemia | Graded by intervention (e.g. insulin started) | Graded by glucose value, e.g. fasting >ULN to 160 mg/dL for Grade 1; Grade 5 removed |
| Hypertension (adult) | Grade 1: systolic 120 to 139 or diastolic 80 to 89 mm Hg | Grade 1 removed; Grade 2 starts at 140 to 159 / 90 to 99 mmHg |
Summary only. Read the exact criteria in the tool or the NCI files.
Applying the criteria
Each term has its own criteria, built on a general guideline: Grade 1 is mild, Grade 2 moderate and limiting instrumental activities of daily living (ADL), Grade 3 severe or medically significant and limiting self-care ADL, Grade 4 life-threatening with urgent intervention indicated, and Grade 5 death related to the AE. In the criteria a semicolon means "or", and a dash means that grade is not available for the term. LLN and ULN are the lower and upper limits of normal of the laboratory that ran the test.
Worked examples in v5.0: a hemoglobin of 9.1 g/dL is anemia Grade 2 (<10.0 to 8.0 g/dL). An ALT of 4 x ULN in a participant with a normal baseline is Grade 2 (>3.0 to 5.0 x ULN). A sodium of 128 mmol/L without symptoms is hyponatremia Grade 2. A potassium of 2.8 mmol/L is hypokalemia Grade 3 (<3.0 to 2.5 mmol/L; hospitalization indicated). When the criteria combine a value and a clinical consequence, the investigator decides which description fits best.
Grading errors tend to repeat across sites unless the protocol and the form prevent them.
Copy the adverse event eCRF template into a free sandbox study, enter a demo event and see the audit trail. No credit card. You pay only when you go live.
Safety data in Capture
The adverse event eCRF template includes a CTCAE grade field (AETOXGR, a 1 to 5 scale) alongside a mild, moderate and severe severity field; you keep the one your protocol uses and delete the other before approving the form. The form carries the AE SDTM domain, so grades export in the variable a statistician expects. Patient-reported symptom data can sit alongside it with the PRO-CTCAE template.
Safety reporting is part of the same platform: serious events raise a safety alert and move through investigator sign-off, as described on adverse event reporting software. Lab results that drive many CTCAE grades live in lab tables with units and reference ranges, covered on lab data and reference range management. Every change to a grade is kept in the field-level audit trail with the reason for change. Capture records the grade the site assigns; it does not grade events for the investigator.
Protocol and AE form
CTCAE v5.0 or v6.0 in the protocol, for the whole study.
CTCAE grade or mild, moderate and severe, not both.
LLN and ULN from the testing laboratory, in the reported unit.
Needed for terms graded against baseline.
Seriousness criteria recorded independently of grade.
Worsening grades recorded per the protocol's AE rules.
NCI released CTCAE v6.0 in 2025, with errata in January 2026. CTCAE v5.0, published 27 November 2017, remains in wide use, and studies that started on v5.0 usually keep it. Use the version your protocol names.
Grade 1 mild, Grade 2 moderate, Grade 3 severe or medically significant but not immediately life-threatening, Grade 4 life-threatening consequences with urgent intervention indicated, and Grade 5 death related to the adverse event.
Grade 1 is <LLN to 1.5 x 10e9/L, Grade 2 <1.5 to 1.0, Grade 3 <1.0 to 0.5 and Grade 4 <0.5 x 10e9/L. CTCAE v6.0 shifted these bands downward.
Not necessarily. Grade describes severity; seriousness depends on criteria such as death, a life-threatening event, hospitalization or disability. They are recorded separately.
CTCAE only lists grades that are appropriate for each term. A dash means that grade is not available, and Grade 5 is not an option for some terms.
No. It shows the published criteria for 34 common terms. Grading is the investigator's clinical judgement, and the official NCI document is the reference.
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