Table 2.
Treatment-Emergent Adverse Events
| SOC/PT | Favipiravir |
|---|---|
| N=1083 | |
| n (%) (E) | |
| Number of patients with at least one event | 129 (11.91) (195) |
| Ear and labyrinth disorders | 1 (0.09) (1) |
| Vertigo | 1 (0.09) (1) |
| Eye disorders | 12 (1.11) (13) |
| Eye irritation | 1 (0.09) (1) |
| Ocular hyperemia | 12 (1.11) (12) |
| Gastrointestinal disorders | 72 (6.65) (90) |
| Abdominal distension | 2 (0.18) (2) |
| Abdominal pain lower | 4 (0.37) (4) |
| Abdominal pain upper | 8 (0.74) (8) |
| Diarrhea | 12 (1.11) (12) |
| Gastritis | 3 (0.28) (3) |
| Gastroesophageal reflux disease | 6 (0.55) (6) |
| Hyperchlorhydria | 5 (0.46) (5) |
| Mouth ulceration | 2 (0.18) (2) |
| Nausea | 22 (2.03) (25) |
| Toothache | 2 (0.18) (2) |
| Vomiting | 20 (1.85) (21) |
| General disorders | 22 (2.03) (22) |
| Asthenia | 19 (1.75) (19) |
| Fatigue | 1 (0.09) (1) |
| Pyrexia | 2 (0.18) (2) |
| Hepatobiliary disorders | 1 (0.09) (1) |
| Hepatomegaly | 1 (0.09) (1) |
| Infections and infestations | 1 (0.09) (1) |
| Nasopharyngitis | 1 (0.09) (1) |
| Investigations | 5 (0.46) (11) |
| Alanine aminotransferase increased | 3 (0.28) (3) |
| Aspartate aminotransferase increased | 2 (0.18) (2) |
| Blood glucose increased | 1 (0.09) (1) |
| Coma scale abnormal | 1 (0.09) (2) |
| Neutrophil count increased | 1 (0.09) (1) |
| Oxygen saturation decreased | 1 (0.09) (1) |
| White blood cell count increased | 1 (0.09) (1) |
| Metabolism and nutrition disorders | 1 (0.09) (1) |
| Decreased appetite | 1 (0.09) (1) |
| Musculoskeletal and connective tissue disorders | 12 (1.11) (19) |
| Arthralgia | 8 (0.74) (8) |
| Muscle spasms | 2 (0.18) (2) |
| Myalgia | 9 (0.83) (9) |
| Nervous system disorders | 19 (1.75) (20) |
| Ageusia | 1 (0.09) (1) |
| Dizziness | 4 (0.37) (4) |
| Headache | 15 (1.39) (15) |
| Psychiatric disorders | 3 (0.28) (3) |
| Anxiety | 3 (0.28) (3) |
| Renal and urinary disorders | 1 (0.09) (1) |
| Dysuria | 1 (0.09) (1) |
| Respiratory, thoracic, and mediastinal disorders | 2 (0.18) (3) |
| Pneumonia aspiration | 1 (0.09) (2) |
| Rales | 1 (0.09) (1) |
| Skin and subcutaneous tissue disorders | 9 (0.83) (9) |
| Rash | 7 (0.65) (7) |
| Skin irritation | 2 (0.18) (2) |
Notes: A patient with multiple AEs was counted only once in the “at least one event” row. At each level of summarization, a patient with multiple AEs within SOC/PT was counted only once. SOCs were presented alphabetically; PTs were sorted within the primary SOC by descending frequency. Percentages were based on the number of patients in the safety analysis set.
Abbreviations: AE, adverse event; E, the total number of events in the safety analysis set; PT, preferred term; SOC, system organ class.