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Table 1 Definition of clinically significant outcomes

From: Prophylactic prednisolone for the prevention of early and intermediate adverse effects of radioactive iodine therapy in patients with thyroid cancer: study protocol for a single-centre, phase II/III, randomized, double-blinded, placebo-controlled clinical trial

Related to

Classification

Symptom

Definition

CTCAE grade and definition

RAI

Local

Neck pain

A disorder characterized by marked discomfort sensation in the neck area

Grade 2 (impairment of instrumental activities of daily living) and above

RAI

Local

Neck swelling

A disorder characterized by marked enlargement in the neck area

Grade 2 (impairment of instrumental ADL) and above

RAI

Local

Dysphagia

A disorder characterized by difficulty in swallowing

Grade 2 (symptomatic and altered eating/swallowing) and above

RAI

Local

Dyspnoea

A disorder characterized by difficulty in breathing

Any grade

RAI

Oral

Sialadenitis

A disorder characterized by an inflammatory process involving the salivary gland

Grade 2 (moderate symptoms; oral intervention indicated) and above

RAI

Oral

Dry mouth

A disorder characterized by reduced salivary flow in the oral cavity

Grade 2 (moderate symptoms; oral intake alterations; unstimulated saliva 0.1 to 0.2 mL/min)

RAI

Oral

Oral mucositis

A disorder characterized by inflammation of the oral mucosal

Grade 2 (moderate pain; not interfering with oral intake; modified diet indicated) and above

RAI

Oral

Oral pain

A disorder characterized by a sensation of marked discomfort in the mouth, tongue or lip

Grade 2 (moderate pain; limiting instrumental ADL) and above

RAI

Oral

Dysgeusia

A disorder characterized by abnormal sensual experience with the taste of foodstuffs

Grade 2 (altered taste with change in diet (e.g. oral supplements), noxious or unpleasant taste, loss of taste) and above

RAI

Gastrointestinal

Nausea

A disorder characterized by a queasy sensation and/or the urge to vomit

Grade 2 (oral intake decreased without significant weight loss, dehydration or malnutrition) and above

RAI

Gastrointestinal

Vomiting

A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth

Grade 2 (3–5 episodes (separated by 5 min) in 24 h) and above

RAI/glucocorticoids

Gastrointestinal

Dyspepsia

A disorder characterized by an uncomfortable, often painful feeling in the stomach, resulting from impaired digestion. Symptoms include burning stomach, bloating, heartburn, nausea and vomiting

Grade 2 (moderate symptoms; medical intervention indicated) or above

RAI/glucocorticoids

Gastrointestinal

Abdominal pain

A disorder characterized by a sensation of marked discomfort in the abdominal region

Grade 2 (moderate pain; limiting instrumental ADL)

RAI

Eye

Xerophthalmia

A disorder characterized by dryness of the cornea and conjunctiva

Grade 2 (symptomatic; multiple agents indicated; limiting instrumental ADL) and above

RAI

Eye

Epiphoria

A disorder of excessive tearing in the eyes

Grade 2 (intervention indicated) and above

RAI

Eye

Conjunctivitis

A disorder characterized by inflammation, to the conjunctiva of the eye

Grade 2 (symptomatic; topical intervention indicated (e.g. antibiotics); limiting instrumental ADL) and above

Glucocorticoids

General

Infections within 2 weeks

A disorder characterized by an infectious process

Grade 2 (any infection that needs intervention) or above

Glucocorticoids

General

Hyperglycaemia during the first 3 days

A disorder characterized by laboratory test results that indicate an elevation in the concentration of blood sugar

Grade 3 (> 250–500 mg/dL; > 13.9–27.8 mmol/L; hospitalization indicated) or above

Glucocorticoids

Central nervous system

Altered sensorium

A disorder characterized by functional disturbances of sensory neurons resulting in abnormal cutaneous sensations of tingling, numbness, pressure, cold and warmth that are experienced in the absence of a stimulus

Grade 2 (moderate symptoms limiting instrumental ADL) and above

Glucocorticoids

Central nervous system

Sleep disturbances

A disorder characterized by excessive or reduced sleepiness or difference in sleep pattern

Grade 2 (moderate disturbance) or above

Glucocorticoids

Central nervous system

Mood changes

A disorder characterized by a state of restlessness, irritability or sadness

Grade 3 (moderate symptoms; hospitalization not indicated) or above

  1. ADL activities of daily living, CTCAE Common Terminology Criteria for Adverse Effects version 4.0