TABLE 2.
Summary of all treatment-emergent adverse events by system organ class and preferred term for each treatment (safety population)a
| System organ class/preferred term | No. (%) of subjects |
||||
|---|---|---|---|---|---|
|
Placebo (n = 6) |
Cohort A (200 mg Q12h) (n = 8) |
Cohort B (400 mg Q12h) (n = 8) |
Cohort C (600 mg Q12h) (n = 8) |
All active (n = 24) |
|
| Subjects with TEAEs | 6 (100.0) | 8 (100.0) | 6 (75.0) | 6 (75.0) | 20 (83.3) |
| Ear and labyrinth disorders | 0 (0.0) | 1 (12.5) | 0 (0.0) | 0 (0.0) | 1 (4.2) |
| Ear discomfort | 0 (0.0) | 1 (12.5) | 0 (0.0) | 0 (0.0) | 1 (4.2) |
| Gastrointestinal disorders | 1 (16.7) | 0 (0.0) | 2 (25.0) | 0 (0.0) | 2 (8.3) |
| Diarrhea | 1 (16.7) | 0 (0.0) | 2 (25.0) | 0 (0.0) | 2 (8.3) |
| General disorders and administration site conditions | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 1 (4.2) |
| Infusion site thrombosis | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 1 (4.2) |
| Infections and infestations | 0 (0.0) | 1 (12.5) | 0 (0.0) | 0 (0.0) | 1 (4.2) |
| Upper respiratory tract infection | 0 (0.0) | 1 (12.5) | 0 (0.0) | 0 (0.0) | 1 (4.2) |
| Injury, poisoning, and procedural complications | 0 (0.0) | 1 (12.5) | 0 (0.0) | 0 (0.0) | 1 (4.2) |
| Arthropod bite | 0 (0.0) | 1 (12.5) | 0 (0.0) | 0 (0.0) | 1 (4.2) |
| Investigations | 4 (66.7) | 5 (62.5) | 4 (50.0) | 6 (75.0) | 15 (62.5) |
| Alanine aminotransferase increased | 0 (0.0) | 1 (12.5) | 0 (0.0) | 2 (25.0) | 3 (12.5) |
| Amylase increased | 0 (0.0) | 1 (12.5) | 1 (12.5) | 1 (12.5) | 3 (12.5) |
| Aspartate aminotransferase increased | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (25.0) | 2 (8.3) |
| Blood bilirubin increased | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 1 (4.2) |
| Blood calcium increased | 0 (0.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) | 1 (4.2) |
| Blood potassium increased | 0 (0.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) | 1 (4.2) |
| Blood pressure, diastolic, decreased | 1 (16.7) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 1 (4.2) |
| Blood pressure, diastolic, increased | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 1 (4.2) |
| Blood pressure, systolic, decreased | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Blood pressure, systolic, increased | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 1 (4.2) |
| Hemoglobin decreased | 1 (16.7) | 2 (25.0) | 1 (12.5) | 1 (12.5) | 4 (16.7) |
| Lipase increased | 2 (33.3) | 1 (12.5) | 2 (25.0) | 2 (25.0) | 5 (20.8) |
| White blood cell count increased | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Musculoskeletal and connective tissue disorders | 0 (0.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) | 1 (4.2) |
| Myalgia | 0 (0.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) | 1 (4.2) |
| Nervous system disorders | 2 (33.3) | 1 (12.5) | 2 (25.0) | 0 (0.0) | 3 (12.5) |
| Dysgeusia | 0 (0.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) | 1 (4.2) |
| Headache | 2 (33.3) | 1 (12.5) | 1 (12.5) | 0 (0.0) | 2 (8.3) |
| Psychiatric disorders | 0 (0.0) | 1 (12.5) | 0 (0.0) | 0 (0.0) | 1 (4.2) |
| Anxiety | 0 (0.0) | 1 (12.5) | 0 (0.0) | 0 (0.0) | 1 (4.2) |
| Respiratory, thoracic, and mediastinal disorders | 0 (0.0) | 0 (0.0) | 1 (12.5) | 1 (12.5) | 2 (8.3) |
| Oropharyngeal pain | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 1 (4.2) |
| Throat irritation | 0 (0.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) | 1 (4.2) |
| Skin and subcutaneous tissue disorders | 0 (0.0) | 0 (0.0) | 2 (25.0) | 0 (0.0) | 2 (8.3) |
| Dry skin | 0 (0.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) | 1 (4.2) |
| Erythema | 0 (0.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) | 1 (4.2) |
a
System organ class and preferred term are from the Medical Dictionary for Regulatory Activities (MedDRA), version 17.0. The number of subjects in each column could not be added because a subject may have had more than one adverse event. A subject experiencing multiple occurrences of the same adverse event was counted, at most, once per system organ class and preferred term for each treatment and once for “all active.” Q12h, every 12 h; TEAE, treatment-emergent adverse event.