Table 2

Primary outcome data

COSPapers containing an ADR in COS (/15)Patients given LTRA in COS*Patients with suspected ADR in COS*Characterised ADRs reported (/48)Papers containing ADR (/15)Patients given LTRAPatients with suspected ADRADR terms given in paper (/73)
Psychiatric disorders1058991100Aggression216218Aggression
Agitation/hyperactivity/irritability/nervousness7586964Agitation; agitation/hyperactivity; agitation/irritability; hyperactivity; irritability; nervousness; nervousness/agitation
Anxiety64561450Anxiety; separation anxiety
Behaviour disorders21085Behaviour problems; tantrums
Bruxism111Bruxism
Depression21072Depression; depressive state
Disorientation121Disorientated when waking
Disturbance in attention111Reduced attention span
Hallucination210255Hallucination
Insomnia31635Insomnia
Mood disorders34502172Change in mood; mood; mood swings; personality
Nyctophobia110244Nyctophobia
Restlessness111Restlessness
Schizophrenia1439513Schizophrenia
Substance-related and addictive disorders1439599Substance-related
Sleep disorders55528245Change in sleeping patterns; difficulty falling asleep without parent; sleep disorder/depression; sleep disturbance; sleeping badly
Sleep terror316410Crying when waking; nightmares
Somnambulism232Sleepwalking
Suicidal ideation111Suicidal ideation
Thinking abnormal111Felt he was going crazy
Gastrointestinal disorders7232735Abdominal pain7232719Abdominal discomfort; abdominal pain; funny feeling in tummy; stomach ache
Aphthous ulcers110242Aphthous ulcers
Diarrhoea13121Diarrhoea
Nausea and vomiting symptoms4119613Nausea; nausea or vomiting; vomiting
Nervous system disorders 7239546Dysesthesia111Dysesthesia
Gait disturbance111Gait disturbance developed
Headache5237321Headache
Nervous system disorders1217Nervous system disorders
Paraesthesia112Diminished sensation of pain and touch; numbness and pain of fingers
Seizure110242Convulsion
Somnolence3144212Excessive sleepiness; drowsiness; drowsiness or lethargy
General disorders and administration site conditions28824Fever28824Fever
Metabolism and nutrition disorders210749Decreased appetite1508Anorexia
Increased appetite110241Increased appetite
Respiratory, thoracic and mediastinal disorders28822Cough18811Cough
Sinusitis111Right paranasal sinusitis
Social circumstances2573Educational problems2573Decline in school performance
Cardiac disorders13121Tachycardia13121Tachycardia
Ear and labyrinth disorders13122Dizziness or vertigo13122Dizziness or vertigo
Hepatobiliary
disorders
1509Abnormal liver function test1509Abnormal liver function test
Immune system disorders111Rheumatoid factor quantitative increased111Higher rheumatoid factor
Musculoskeletal and connective tissue disorders116Arthritis111Arthritis
Arthralgia111Polyarthralgia
Churg-Strauss syndrome111Churg-Strauss syndrome
Muscle atrophy111Muscle atrophy
Muscle weakness in arm111Muscle weakness in arm
Myalgia111Myalgia
Skin and subcutaneous tissue disorders110243Rash110243Rash
  • Reported ADR data presented using Medical Dictionary for Regulatory Activities terminology and organised into COS. See method for ADR characterising process.

  • ADR, adverse drug reaction; COS, Core Outcome Set; LTRA, leukotriene receptor antagonist .