Table 3

Estimated likelihood of ADR presentation reported in prospective studies and RCT

COS of ADRCharacterised ADRPapers containing ADR (/4)Patients with suspected ADR across prospective studiesLikelihood (%) of patient to experience an LTRA—induced ADRSmPC frequency term
Psychiatric disordersAgitation/hyperactivity/irritability/nervousness1242.3Common
Psychiatric disordersAggression1111.0Common
Nervous system disordersHeadache2111.0Common
Abnormal liver function test190.9Uncommon
Metabolism and nutrition disordersDecreased appetite180.8Uncommon
Nervous system disordersNervous system disorders170.7Uncommon
Psychiatric disordersSleep terror170.7Uncommon
Psychiatric disordersAnxiety170.7Uncommon
Gastrointestinal disordersNausea and vomiting symptoms150.5Uncommon
General disorders and administration site conditionsFever130.3Uncommon
Psychiatric disordersInsomnia130.3Uncommon
Social circumstancesDecline in school performance120.2Uncommon
Gastrointestinal disordersAbdominal pain120.2Uncommon
Respiratory, thoracic and mediastinal disordersCough110.1Uncommon
  • A total of 1050 patients administered an LTRA across the four prospective studies and RCT. See method for ADR characterising process.

  • ADR, adverse drug reaction; LTRA, leukotriene receptor antagonist ; RCT, randomised control trial; SmPC, Summary of Product Characteristics.