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. Author manuscript; available in PMC: 2018 Dec 1.
Published in final edited form as: Lancet Infect Dis. 2017 Sep 22;17(12):1255–1265. doi: 10.1016/S1473-3099(17)30476-0

Table 4.

Number of Participants with Hospitalization and/or Serious Adverse Events -Total, and by Treatment Arm (ITT Population) including all events reported after randomization through to Day 28

Randomized Treatment
Event Total
(N=626)
Combination
Antivirals
(N=314)
Oseltamivir
(N=312)
Any Hospitalization 16 (3%) 13 (4%) 3 (1%)

Serious Adverse Events
  Any Serious Adverse Events 20 (3%) 14 (4%) 6 (2%)
  Respiratory, thoracic and mediastinal disorders 5 (1%) 4 (1%) 1 (<0·5%)
    Asthma 2 (<0·5%) 2 (1%) 0 (0%)
    Pulmonary oedema 1 (<0·5%) 1 (<0·5%) 0 (0%)
    Respiratory distress 1 (<0·5%) 1 (<0·5%) 0 (0%)
    Bronchospasm 1 (<0·5%) 0 (0%) 1 (<0·5%)
  Gastrointestinal disorders 4 (1%) 4 (1%) 0 (0%)
    Diarrhoea 2 (<0·5%) 2 (1%) 0 (0%)
    Nausea 1 (<0·5%) 1 (<0·5%) 0 (0%)
    Diarrhoea haemorrhagic 1 (<0·5%) 1 (<0·5%) 0 (0%)
  Infections and infestations 4 (1%) 3 (1%) 1 (<0·5%)
    Pneumonia 2 (<0·5%) 1 (<0·5%) 1 (<0·5%)
    Gastroenteritis 1 (<0·5%) 1 (<0·5%) 0 (0%)
    Cellulitis 1 (<0·5%) 1 (<0·5%) 0 (0%)
  Cardiac disorders 3 (<0·5%) 2 (1%) 1 (<0·5%)
    Atrial fibrillation 1 (<0·5%) 1 (<0·5%) 0 (0%)
    Cardiac failure 1 (<0·5%) 0 (0%) 1 (<0·5%)
    Atrial tachycardia 1 (<0·5%) 1 (<0·5%) 0 (0%)
  Psychiatric disorders 2 (<0·5%) 0 (0%) 2 (1%)
    Delirium 1 (<0·5%) 0 (0%) 1 (<0·5%)
    Personality change 1 (<0·5%) 0 (0%) 1 (<0·5%)
  Skin and subcutaneous tissue disorders 1 (<0·5%) 1 (<0·5%) 0 (0%)
    Diabetic foot 1 (<0·5%) 1 (<0·5%) 0 (0%)
  Metabolism and nutrition disorders 1 (<0·5%) 1 (<0·5%) 0 (0%)
    Dehydration 1 (<0·5%) 1 (<0·5%) 0 (0%)
  Injury, poisoning and procedural complications 1 (<0·5%) 1 (<0·5%) 0 (0%)
    Spinal compression fracture 1 (<0·5%) 1 (<0·5%) 0 (0%)
  Injury, poisoning and procedural complications 1 (<0·5%) 0 (0%) 1 (<0·5%)
    Febrile neutropenia 1 (<0·5%) 0 (0%) 1 (<0·5%)