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%) |