Table 2.
Primary outcome data
| COS | Papers 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 LTRA | Patients with suspected ADR | ADR terms given in paper (/73) |
| Psychiatric disorders | 10 | 5899 | 1100 | Aggression | 2 | 162 | 18 | Aggression |
| Agitation/hyperactivity/irritability/nervousness | 7 | 5869 | 64 | Agitation; agitation/hyperactivity; agitation/irritability; hyperactivity; irritability; nervousness; nervousness/agitation | ||||
| Anxiety | 6 | 4561 | 450 | Anxiety; separation anxiety | ||||
| Behaviour disorders | 2 | 108 | 5 | Behaviour problems; tantrums | ||||
| Bruxism | 1 | 1 | 1 | Bruxism | ||||
| Depression | 2 | 107 | 2 | Depression; depressive state | ||||
| Disorientation | 1 | 2 | 1 | Disorientated when waking | ||||
| Disturbance in attention | 1 | 1 | 1 | Reduced attention span | ||||
| Hallucination | 2 | 1025 | 5 | Hallucination | ||||
| Insomnia | 3 | 163 | 5 | Insomnia | ||||
| Mood disorders | 3 | 4502 | 172 | Change in mood; mood; mood swings; personality | ||||
| Nyctophobia | 1 | 1024 | 4 | Nyctophobia | ||||
| Restlessness | 1 | 1 | 1 | Restlessness | ||||
| Schizophrenia | 1 | 4395 | 13 | Schizophrenia | ||||
| Substance-related and addictive disorders | 1 | 4395 | 99 | Substance-related | ||||
| Sleep disorders | 5 | 5528 | 245 | Change in sleeping patterns; difficulty falling asleep without parent; sleep disorder/depression; sleep disturbance; sleeping badly | ||||
| Sleep terror | 3 | 164 | 10 | Crying when waking; nightmares | ||||
| Somnambulism | 2 | 3 | 2 | Sleepwalking | ||||
| Suicidal ideation | 1 | 1 | 1 | Suicidal ideation | ||||
| Thinking abnormal | 1 | 1 | 1 | Felt he was going crazy | ||||
| Gastrointestinal disorders | 7 | 2327 | 35 | Abdominal pain | 7 | 2327 | 19 | Abdominal discomfort; abdominal pain; funny feeling in tummy; stomach ache |
| Aphthous ulcers | 1 | 1024 | 2 | Aphthous ulcers | ||||
| Diarrhoea | 1 | 312 | 1 | Diarrhoea | ||||
| Nausea and vomiting symptoms | 4 | 1196 | 13 | Nausea; nausea or vomiting; vomiting | ||||
| Nervous system disorders | 7 | 2395 | 46 | Dysesthesia | 1 | 1 | 1 | Dysesthesia |
| Gait disturbance | 1 | 1 | 1 | Gait disturbance developed | ||||
| Headache | 5 | 2373 | 21 | Headache | ||||
| Nervous system disorders | 1 | 21 | 7 | Nervous system disorders | ||||
| Paraesthesia | 1 | 1 | 2 | Diminished sensation of pain and touch; numbness and pain of fingers | ||||
| Seizure | 1 | 1024 | 2 | Convulsion | ||||
| Somnolence | 3 | 1442 | 12 | Excessive sleepiness; drowsiness; drowsiness or lethargy | ||||
| General disorders and administration site conditions | 2 | 882 | 4 | Fever | 2 | 882 | 4 | Fever |
| Metabolism and nutrition disorders | 2 | 1074 | 9 | Decreased appetite | 1 | 50 | 8 | Anorexia |
| Increased appetite | 1 | 1024 | 1 | Increased appetite | ||||
| Respiratory, thoracic and mediastinal disorders | 2 | 882 | 2 | Cough | 1 | 881 | 1 | Cough |
| Sinusitis | 1 | 1 | 1 | Right paranasal sinusitis | ||||
| Social circumstances | 2 | 57 | 3 | Educational problems | 2 | 57 | 3 | Decline in school performance |
| Cardiac disorders | 1 | 312 | 1 | Tachycardia | 1 | 312 | 1 | Tachycardia |
| Ear and labyrinth disorders | 1 | 312 | 2 | Dizziness or vertigo | 1 | 312 | 2 | Dizziness or vertigo |
| Hepatobiliary disorders |
1 | 50 | 9 | Abnormal liver function test | 1 | 50 | 9 | Abnormal liver function test |
| Immune system disorders | 1 | 1 | 1 | Rheumatoid factor quantitative increased | 1 | 1 | 1 | Higher rheumatoid factor |
| Musculoskeletal and connective tissue disorders | 1 | 1 | 6 | Arthritis | 1 | 1 | 1 | Arthritis |
| Arthralgia | 1 | 1 | 1 | Polyarthralgia | ||||
| Churg-Strauss syndrome | 1 | 1 | 1 | Churg-Strauss syndrome | ||||
| Muscle atrophy | 1 | 1 | 1 | Muscle atrophy | ||||
| Muscle weakness in arm | 1 | 1 | 1 | Muscle weakness in arm | ||||
| Myalgia | 1 | 1 | 1 | Myalgia | ||||
| Skin and subcutaneous tissue disorders | 1 | 1024 | 3 | Rash | 1 | 1024 | 3 | Rash |
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.