Skip to main content

Table 2 Toxicity grading scale for determining the severity of clinical adverse events

From: Double blind, randomized controlled trial, to evaluate the effectiveness of a controlled nitric oxide releasing patch versus meglumine antimoniate in the treatment of cutaneous leishmaniasis [NCT00317629]

SYSTEMIC

 

Grade 1 (Mild)

Grade 2 (Moderate)

Grade 3* (Severe)

Grade 4* (Life-threatening)

Fever: oral1

38 – 38.5°C

38.6 – 39.5°C

39.6 – 40.5°C

>40.5°C

Headache1

Mild; no Rx required

Transient, moderate; Rx required

Severe; responds to initial narcotic Rx

Intractable; required repeated narcotic Rx

Allergic reaction1

Pruritus without rash

Localized urticaria

Generalized urticaria; angioedema

Anaphylaxis

GASTROINTESTINAL

Nausea1

Mild discomfort; maintains reasonable intake

Moderate discomfort; intake decreased significantly; some activity limited

Severe discomfort; no significant intake; activities limited

Minimal fluid intake

Vomiting2

1 episode in 24 hours

2 – 5 episodes in 24 hours

> 6 episodes in 24 hours or needing IV fluids

Physiologic consequences requiring hospitalization or parenteral nutrition

Diarrhea2

Mild or transient; 3–4 loose stools/day or mild diarrhea lasting < 1 week

Moderate or persistent; 5–7 loose stools/day or diarrhea lasting > 1 week.

>7 loose stools/day or bloody diarrhea; or orthostatic hypotension or electrolyte imbalance or >2 LIV fluids required

Hypotensive shock or physiologic consequences requiring hospitalization

Oral discomfort2

Mild discomfort; no difficulty swallowing

Some limits on eating/drinking

Eating/talking very limited; unable to swallow solid food

Unable to drink fluids; requires IV fluids

CARDIOVASCULAR

Cardiac rhythm2

----

Asymptomatic, transient signs, no Rx required

Recurrent/persistent symptomatic Rx required

Unstable dysrythmia; hospitalization and Rx required

Hypertension1

Transient increase > 20 mmHg; no Rx

Recurrent, chronic > 20 mmHg, Rx required

Requires acute Rx; no hospitalization

Requires hospitalization

Hypotension1

Transient orthostatic hypotension, no Rx

Symptoms corrected with oral fluids

Requires IV fluids; no hospitalization required

Requires hospitalization

MUSCULOSKELETAL

Arthralgia2(joint pain)

Mild pain not interfering with function

Moderate pain, analgesics and/or pain interfering with function but not with ADL

Severe pain; pain and/or analgesics interfering with ADL

Disabling pain

Myalgia2

Myalgia with no limitation of activity

Muscle tenderness (at other than injection 2site) or with moderate impairment of activity

Severe muscle tenderness with marked impairment of activity

Frank myonecrosis

RESPIRATORY

Cough3

Mild, relieved by non-prescription medication only

Symptomatic requiring narcotic prescription medication

Symptomatic and significantly interfering with sleep or ADL

NA

Dyspnea3

Dyspnea on exertion, but can walk one flight of stairs without stopping

Dyspnea on exertion, but unable to walk 1 flight of stairs or 1 city block (0.1 Km) without stopping

Dyspnea interfering with ADL

Dyspnea at rest requiring oxygen therapy; intubation/ventilator indicated

  1. 1 = WHO Toxicity Grading Scale; 2 = DMID, NIH, Adult Toxicity Table; 3 = CTCAE v3.0; *Report Grade 3 and Grade 4 adverse events to the investigators in charge.
  2. ADL: Activities of daily living
  3. Ref: Toxicity Grading based on CTCAE v3.0 DCTD, NCI, NIH, DHHS December 12, 2003 http://ctep.cancer.gov.