Table 2.
Type and Duration of Adverse Events
| System Organ Class Preferred Term |
Baloxavir Marboxil (N = 107) |
|||
|---|---|---|---|---|
| Any Grade | Grade 2 | |||
| n (%) | Number of Events [Duration of AE: Min, Max]a | n (%) | Number of Events [Duration of AE: Min, Max]a | |
| Patients with any AE | 37 (34.6) | 49 [1, NR] | 19 (17.8) | 22 [3, NR] |
| Infections and infestations | 14 (13.1) | 15 [3, 16] | 14 (13.1) | 15 [3, 16] |
| Pharyngitis | 3 (2.8) | 3 [9, 12] | 3 (2.8) | 3 [9, 12] |
| Bronchitis | 2 (1.9) | 2 [8, 12] | 2 (1.9) | 2 [8, 12] |
| Sinusitis | 2 (1.9) | 2 [8, 16] | 2 (1.9) | 2 [8,16] |
| Oral herpes | 2 (1.9) | 2 [6, 8] | 2 (1.9) | 2 [6, 8] |
| Gastroenteritis | 1 (0.9) | 1 [3] | 1 (0.9) | 1 [3] |
| Influenza | 1 (0.9) | 1 [7] | 1 (0.9) | 1 [7] |
| Nasopharyngitis | 1 (0.9) | 1 [6] | 1 (0.9) | 1 [6] |
| Varicella | 1 (0.9) | 1 [12] | 1 (0.9) | 1 [12] |
| Bacterial infection | 1 (0.9) | 1 [5] | 1 (0.9) | 1 [5] |
| Bacterial rhinitis | 1 (0.9) | 1 [11] | 1 (0.9) | 1 [11] |
| Metabolism and nutrition disorders | 1 (0.9) | 1 [3] | 1 (0.9) | 1 [3] |
| Dehydration | 1 (0.9) | 1 [3] | 1 (0.9) | 1 [3] |
| Psychiatric disorders | 1 (0.9) | 1 [1] | 0 | 0 |
| Nightmare | 1 (0.9) | 1 [1] | 0 | 0 |
| Nervous system disorders | 2 (1.9) | 2 [1, 2] | 0 | 0 |
| Headache | 2 (1.9) | 2 [1, 2] | 0 | 0 |
| Respiratory, thoracic, and mediastinal disorders | 4 (3.7) | 5 [4, 46] | 3 (2.8) | 4 [6, 46] |
| Upper respiratory tract inflammation | 2 (1.9) | 3 [6, 14] | 2 (1.9) | 3 [6, 14] |
| Epistaxis | 1 (0.9) | 1 [4] | 0 | 0 |
| Rhinitis allergic | 1 (0.9) | 1 [46] | 1 (0.9) | 1 [46] |
| Gastrointestinal disorders | 16 (15.0) | 16 [1, NR] | 0 | 0 |
| Vomiting | 8 (7.5) | 8 [1, 3] | 0 | 0 |
| Diarrhea | 3 (2.8) | 3 [1, 2] | 0 | 0 |
| Constipation | 2 (1.9) | 2 [3, 3] | 0 | 0 |
| Dental caries | 1 (0.9) | 1 [NR] | 0 | 0 |
| Acetonaemic vomiting | 1 (0.9) | 1 [1] | 0 | 0 |
| Feces, soft | 1 (0.9) | 1 [1] | 0 | 0 |
| Skin and subcutaneous tissue disorders | 2 (1.9) | 2 [3, NR] | 1 (0.9) | 1 [3] |
| Dry skin | 1 (0.9) | 1 [NR] | 0 | 0 |
| Urticaria | 1 (0.9) | 1 [3] | 1 (0.9) | 1 [3] |
| Musculoskeletal and connective tissue disorders | 2 (1.9) | 2 [2, 8] | 0 | 0 |
| Back pain | 1 (0.9) | 1 [2] | 0 | 0 |
| Myalgia | 1 (0.9) | 1 [8] | 0 | 0 |
| Investigations | 2 (1.9) | 3 [5, 11] | 0 | 0 |
| Alanine aminotransferase increased | 1 (0.9) | 1 [11] | 0 | 0 |
| Aspartate aminotransferase increased | 1 (0.9) | 1 [10] | 0 | 0 |
| Blood urine present | 1 (0.9) | 1 [5] | 0 | 0 |
| Injury, poisoning, and procedural complications | 2 (1.9) | 2 [6, NR] | 1 (0.9) | 1 [NR] |
| Ligament sprain | 2 (1.9) | 2 [6, NR] | 1 (0.9) | 1 [NR] |
All AEs were classified as grade 1 or grade 2. Most AEs (26 patients) occurred in the first 7 days, although 3 patients reported AEs on day 22 or later (nasopharyngitis, ligament sprain, oral herpes; none were considered to be study drug related).Abbreviations: AE, adverse event; Max, maximum; Min, minimum; NR, not recorded.
aDuration of AE (days) = (date of outcome) − (date of onset) + 1. If the AE did not resolve or was not resolving until the day of outcome assessment, duration of the AE is defined as NR.