Friday, July 17, 2026
🇺🇸 FDA

Clinical Research Tool · Trial Safety · CTCAE v6.0

CTCAE Adverse Event Grader

Free CTCAE severity grader for oncology and pharma clinical trial safety teams. Orient Grade 1–5 from case signals, then confirm the official term-specific criterion before EDC entry and regulatory reporting.

Term-specific CTCAE criteria supersede this generic helper. This page intentionally does not reproduce official NCI CTCAE term tables or controlled terminology.

Quick Answer

CTCAE (Common Terminology Criteria for Adverse Events) grades adverse event severity from Grade 1 (mild) through Grade 5 (death related to the AE) using term-specific clinical criteria published by NCI. In oncology and pharma clinical trials, sites and clinical research associates document the event, code it in MedDRA, assign the applicable CTCAE grade, then separately assess ICH E2A seriousness, causality, and expectedness. This free grader orients generic Grade 1-5 severity from case signals—it does not replace official NCI CTCAE v6.0 term tables or sponsor SOPs for regulatory submission.

Interactive helper

Estimate the likely general CTCAE grade

Select severity signals from the case narrative. The result is a general orientation only and must be reconciled against the official CTCAE term selected for the event.

Clinical severity signals
Serious severity signals

Select any signal present in the case. Death and life-threatening consequences take priority over lower-grade signals.

Likely general grade

Result pending

Select severity signals and run the helper.

Selected rationale

  • No signals selected yet.

Review note

Run the helper, then confirm the event-specific CTCAE criterion and protocol rules.

CTCAE v6.0 reference

General CTCAE Grade 1-5 Definitions

NCI CTCAE v6.0 uses these public general grade concepts as a framework. Individual adverse event terms may have unique clinical or laboratory thresholds and may not include every grade. NCI released v6.0 in 2025 with MedDRA 28.0; new trials target v6.0 implementation from January 1, 2026.

Grade 1

Mild

Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.

Grade 2

Moderate

Minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living.

Grade 3

Severe or medically significant

Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living.

Grade 4

Life-threatening

Life-threatening consequences; urgent intervention indicated.

Grade 5

Death

Death related to adverse event.

Safety concepts

Severity vs Seriousness

Severity

CTCAE grade describes clinical intensity. Grade 3 can be severe or medically significant; Grade 4 is life-threatening; Grade 5 is death related to the AE.

Seriousness

Seriousness is a regulatory reporting classification based on outcomes such as death, life-threatening risk, hospitalization, disability, congenital anomaly, or important medical event.

Severity and seriousness often overlap but are not interchangeable. A Grade 3 event may trigger urgent medical review, but SAE classification still requires separate seriousness assessment under the protocol, ICH rules, and local regulations. Use our ICH E2A Seriousness Checker after assigning CTCAE grade.

Terminology

How CTCAE Relates to MedDRA

CTCAE is a descriptive terminology for adverse event reporting with a severity scale for each AE term. MedDRA is the broader medical terminology used for regulatory coding, case retrieval, tabulation, and signal analysis.

In oncology trial operations, sites typically document the reported event, code or map it according to the trial's MedDRA version and conventions, then assign CTCAE severity using the applicable term-specific criterion. This page provides public explanatory context only and is not a MedDRA or CTCAE dictionary.

Oncology trial workflow

Adverse Event Grading Workflow

1

Capture the adverse event term

Record the reported sign, symptom, laboratory abnormality, or diagnosis as the adverse event, with onset, resolution, outcome, and supporting source documentation.

2

Code the event consistently

Map the event to the appropriate MedDRA concept and trial dictionary version according to the protocol and coding conventions.

3

Grade severity

Use the term-specific CTCAE criterion when available. If reviewing at a high level, use the generic Grade 1-5 descriptions as orientation only.

4

Assess seriousness and causality

Separately assess SAE seriousness criteria, relationship to study intervention, expectedness against RSI or label, and whether expedited reporting may be required.

5

Document and reconcile

Enter the AE in the trial system, reconcile with labs, concomitant medications, hospitalization records, and safety reports, and update grade if new information changes severity.

Clinical caveats

Term-Specific CTCAE Criteria Supersede Generic Grades

  • Do not grade an event solely from the generic descriptions when the selected CTCAE term has a specific clinical threshold, laboratory threshold, duration, intervention, or outcome criterion.
  • Some CTCAE terms have fewer than five grade options because not every severity level is clinically appropriate for that event.
  • Hospitalization may support Grade 3 in the generic framework, but hospitalization also requires separate SAE seriousness review and may have protocol-specific reporting rules.
  • Grade 5 should be used only when death is related to the adverse event being graded.
  • For CTCAE v6.0 neutropenia, ANC thresholds shifted versus v5.0—confirm protocol dictionary version before comparing grades across studies (see Evidence section).
  • For multi-symptom presentations, confirm whether one CTCAE term, multiple AE terms, or a diagnosis best represents the documented event.

Pharma clinical ops

CTCAE Grading for Pharma & Clinical Trial Teams

Clinical research associates, medical monitors, and safety physicians use CTCAE grading daily in EDC reconciliation, dose-modification review, and DSMB safety tables. Grade assignment must align with the protocol-locked CTCAE version, MedDRA dictionary, and sponsor AE conventions—not colloquial diagnosis labels or generic severity alone.

After orienting severity with this helper, triage ICH E2A seriousness with the Seriousness Checker, align visit windows using the Visit Schedule Generator, and draft protocol safety language with the Protocol Synopsis tool. For expedited reporting decisions, continue to SUSAR Assessment once seriousness, causality, and expectedness are documented.

CTCAE v6.0 neutropenia grade changes affect eligibility cutoffs, dose-hold rules, and cross-trial safety comparisons—teams migrating from v5.0 should reference NCI v5-to-v6 mapping resources and sponsor statistical analysis plans before re-benchmarking toxicity rates.

Evidence

Evidence & Sources

Frequently Asked Questions

CTCAE grading assigns adverse event severity from Grade 1 (mild) through Grade 5 (death related to the AE) using term-specific criteria in the NCI Common Terminology Criteria for Adverse Events. Oncology and pharma trials use CTCAE to standardize toxicity documentation, dose-modification rules, eligibility thresholds, and safety tables across protocols and sponsors.
CTCAE v6.0 (2025) shifts neutrophil count grading upward by one level compared with v5.0: ANC 1500–1000/µL is now Grade 1 (was Grade 2), ANC 1000–500/µL is Grade 2 (was Grade 3), ANC 500–100/µL is Grade 3 (was Grade 4), and Grade 4 is ANC <100/µL (was <500/µL). The old v1–5 Grade 1 band from lower limit of normal to 1500/µL no longer exists. Confirm the CTCAE version locked in your protocol before grading.
No. CTCAE grade describes clinical intensity (Grade 1–5). ICH E2A seriousness is a regulatory outcome classification (death, life-threatening, hospitalization, disability, congenital anomaly, or important medical event). A Grade 3 CTCAE event may or may not meet SAE criteria; a clinically modest event can be serious if it requires intervention to prevent hospitalization or death. After grading, run our Pharmacovigilance Seriousness Checker (/pharmacovigilance/seriousness-checker) for ICH E2A triage.
Each CTCAE v6.0 term maps to a MedDRA Lowest Level Term (LLT)—CTCAE v6.0 uses MedDRA 28.0. MedDRA supports regulatory coding, retrieval, and tabulation; CTCAE adds severity grading descriptions for oncology adverse events. Trial teams document the verbatim term, code to the protocol MedDRA version, then assign CTCAE severity using the selected term-specific criterion—not the colloquial diagnosis label alone.
Grade 5 is used when death is related to the adverse event being graded. Assign Grade 5 only after medical review establishes that relationship under trial documentation rules. Grade 5 is not available for every CTCAE term—a dash (—) in the official table means that grade does not apply to that event.
No. This page provides public general grade definitions and a generic signal-based helper only. Official term-specific CTCAE criteria, the NCI CTCAE dictionary, protocol AE instructions, and sponsor SOPs supersede any online calculator. NCI CTCAE content is the authoritative source for regulatory documentation—you cannot substitute this tool or third-party graders for NCI tables in CSR or safety submissions.
A typical CRA and safety-physician workflow: (1) capture verbatim AE with onset, resolution, and source documents; (2) code to MedDRA per protocol dictionary version; (3) select the correct CTCAE term and assign term-specific grade; (4) assess ICH E2A seriousness, causality, and expectedness against IB/RSI; (5) enter the EDC record and reconcile with labs, con meds, and hospitalization records; (6) query sites when grade changes with new information. Use our Visit Schedule Generator (/clinical-tools/visit-schedule) and Protocol Synopsis tool (/clinical-tools/protocol-synopsis) for aligned trial-ops documentation.
Not every grade is clinically appropriate for every adverse event. The official CTCAE uses a dash (—) when a grade is not applicable—including Grade 5 (death) for terms where death is not a meaningful severity level for that event. Always grade against the selected term row, not the generic Grade 1–5 framework alone.
NCI targets CTCAE v6.0 implementation for newly opened studies from January 1, 2026. Ongoing trials locked to v5.0 should continue per protocol unless the sponsor formally migrates dictionary version mid-study—a complex change requiring mapping, EDC updates, and statistical analysis plan alignment. Cross-version neutropenia comparisons may require reporting raw ANC thresholds alongside grades.
CTCAE grade answers how severe the event was clinically. SAE reporting under ICH E2A/E2D answers whether regulatory seriousness criteria are met and whether expedited reporting may be required. Hospitalization may support Grade 3 in CTCAE while also triggering the hospitalization seriousness criterion—but grade and seriousness are assessed and documented separately in the safety database.
Always use term-specific criteria when an official CTCAE term exists for the event—especially laboratory thresholds (neutrophils, platelets, liver enzymes), intervention requirements, and duration rules. Generic Grade 1–5 descriptions are orientation only. Misgrading febrile neutropenia below Grade 3 or assigning Grade 3+ to alopecia are common publication errors because term-specific limits were ignored.
Third-party graders such as MDCalc (hematologic/lymphatic subset) and OncoDaily (v6.0 SOC picker with lab entry) help quick orientation but cover partial term lists and are not regulatory substitutes. NovaPharmaNews adds pharma clinical-ops context—seriousness triage, visit scheduling, protocol synopsis—without reproducing copyrighted NCI term tables. Confirm every grade against the current NCI CTCAE document before trial documentation.

Related Clinical & Safety Tools

SAE ICH E2A Seriousness Checker VIS Visit Schedule Generator SAP Protocol Synopsis SUSAR SUSAR Assessment N Sample Size Calculator

Drug approvals, clinical trials, M&A, event intelligence, and company updates — weekly.

Customize topics & region
Topics
Region

No spam. Unsubscribe anytime. See our privacy policy.