CTCAE RápidoAdverse event grades · CTCAE v6.0

Psychiatric disorders

The 21 CTCAE v6.0 adverse events in Psychiatric disorders, with grades 1 to 5.

  1. G1Mild mood alteration
  2. G2Moderate mood alteration
  3. G3Severe agitation; hospitalization not indicated
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a state of restlessness associated with unpleasant feelings of irritability and tension.

MedDRA code (LLT): 10001497 · CTCAE v6.0 (NCI), original English text.

  1. G1Inability to achieve orgasm not adversely affecting relationship
  2. G2Inability to achieve orgasm adversely affecting relationship
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by an inability to achieve orgasm.

MedDRA code (LLT): 10002652 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe symptoms; hospitalization indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by apprehension of danger and dread accompanied by restlessness, tension, tachycardia, and dyspnea unattached to a clearly identifiable stimulus.

MedDRA code (LLT): 10002855 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild disorientation
  2. G2Moderate disorientation; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe disorientation; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; urgent intervention indicated
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a lack of clear and orderly thought and behavior.

MedDRA code (LLT): 10010300 · CTCAE v6.0 (NCI), original English text.

  1. G1Delay in achieving orgasm not adversely affecting relationship
  2. G2Delay in achieving orgasm adversely affecting relationship
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by sexual dysfunction characterized by a delay in climax.

MedDRA code (LLT): 10057066 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild acute confusional state
  2. G2Moderate and acute confusional state; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe and acute confusional state; hospitalization indicated; urgent intervention indicated; new onset; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences, threats of harm to self or others; urgent intervention indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by the acute and sudden development of confusion, illusions, movement changes, inattentiveness, agitation, and hallucinations. Usually, it is a reversible condition.

MedDRA code (LLT): 10012218 · CTCAE v6.0 (NCI), original English text.

  1. G1Not applicable
  2. G2Moderate delusional symptoms
  3. G3Severe delusional symptoms; outpatient management; new onset
  4. G4Life-threatening consequences, threats of harm to self or others; hospitalization indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by false personal beliefs held contrary to reality, despite contradictory evidence and common sense.

MedDRA code (LLT): 10012260 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild depressive symptoms
  2. G2Moderate depressive symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe depressive symptoms; hospitalization not indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences, threats of harm to self or others; hospitalization indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by melancholic feelings of grief or unhappiness.

MedDRA code (LLT): 10012378 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild mood elevation
  2. G2Moderate mood elevation
  3. G3Severe mood elevation (e.g., hypomania)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by an exaggerated feeling of well-being which is disproportionate to events and stimuli.

MedDRA code (LLT): 10015533 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild hallucinations (e.g., perceptual distortions)
  2. G2Moderate hallucinations
  3. G3Severe hallucinations; hospitalization not indicated
  4. G4Life-threatening consequences, threats of harm to self or others; hospitalization indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by a false sensory perception in the absence of an external stimulus.

MedDRA code (LLT): 10019077 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild difficulty falling asleep, staying asleep or waking up early
  2. G2Moderate difficulty falling asleep, staying asleep or waking up early
  3. G3Severe difficulty in falling asleep, staying asleep or waking up early
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by difficulty in falling asleep and/or remaining asleep.

MedDRA code (LLT): 10022437 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild; easily consolable
  2. G2Moderate; increased attention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe abnormal or excessive response; inconsolable; medical or psychiatric intervention indicated; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by an abnormal responsiveness to stimuli or physiological arousal; may be in response to pain, fright, a drug, an emotional situation or a medical condition.

MedDRA code (LLT): 10022998 · CTCAE v6.0 (NCI), original English text.

  1. G1Decrease in sexual interest not adversely affecting relationship
  2. G2Decrease in sexual interest adversely affecting relationship
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a decrease in sexual desire.

MedDRA code (LLT): 10024419 · CTCAE v6.0 (NCI), original English text.

  1. G1Present
  2. G2Not applicable
  3. G3Not applicable
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by an increase in sexual desire.

MedDRA code (LLT): 10024421 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild manic symptoms (e.g., elevated mood, rapid thoughts, rapid speech, decreased need for sleep)
  2. G2Moderate manic symptoms (e.g., relationship and work difficulties; poor hygiene)
  3. G3Severe manic symptoms (e.g., hypomania; major sexual or financial indiscretions); hospitalization not indicated; new onset
  4. G4Life-threatening consequences, threats of harm to self or others; hospitalization indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by excitement of psychotic proportions manifested by mental and physical hyperactivity, disorganization of behavior and elevation of mood.

MedDRA code (LLT): 10026749 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild personality change
  2. G2Moderate personality change
  3. G3Severe personality change; hospitalization not indicated
  4. G4Life-threatening consequences, threats of harm to self or others; hospitalization indicated
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by a conspicuous change in a person's behavior and thinking.

MedDRA code (LLT): 10034719 · CTCAE v6.0 (NCI), original English text.

  1. G1Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
  2. G2Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe or medically significant but not immediately life-threatening; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Life-threatening consequences; hospitalization or urgent intervention indicated
  5. G5Death
Definition and note

MedDRA code (LLT): 10037175 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild psychotic symptoms
  2. G2Moderate psychotic symptoms (e.g., disorganized speech; impaired reality testing)
  3. G3Severe psychotic symptoms (e.g., paranoid, extreme disorganization); hospitalization not indicated; new onset
  4. G4Life-threatening consequences, threats of harm to self or others; hospitalization indicated
  5. G5Death
Definition and note

DefinitionA disorder characterized by personality change, impaired functioning, and loss of touch with reality. It may be a manifestation of schizophrenia, bipolar disorder or brain tumor.

MedDRA code (LLT): 10037234 · CTCAE v6.0 (NCI), original English text.

  1. G1Mild symptoms; intervention not indicated
  2. G2Moderate symptoms; limiting instrumental ADL or mild/moderate impact on age-appropriate normal daily activity (pediatric)
  3. G3Severe symptoms; limiting self-care ADL or severe impact on age-appropriate normal daily activity (pediatric)
  4. G4Not applicable
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by an inability to rest, relax or be still.

MedDRA code (LLT): 10038743 · CTCAE v6.0 (NCI), original English text.

  1. G1Increased thoughts of death but no wish to kill oneself
  2. G2Suicidal ideation with no specific plan or intent
  3. G3Specific plan to commit suicide without serious intent to die which may not require hospitalization
  4. G4Specific plan to commit suicide with serious intent to die which requires hospitalization
  5. G5Not applicable
Definition and note

DefinitionA disorder characterized by thoughts of taking one's own life.

MedDRA code (LLT): 10042458 · CTCAE v6.0 (NCI), original English text.

  1. G1Not applicable
  2. G2Not applicable
  3. G3Suicide attempt or gesture without intent to die
  4. G4Suicide attempt with intent to die which requires hospitalization
  5. G5Death
Definition and note

DefinitionA disorder characterized by self-inflicted harm in an attempt to end one's own life.

MedDRA code (LLT): 10042464 · CTCAE v6.0 (NCI), original English text.

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