Table 2.
Unsolicited AEs and their intensity, safety evaluation set, n = 180. X = Number of volunteers with at least one AE; % = Percentage of volunteers with at least one AE in the group; Y = Total number of events. MedDRA (Medical Dictionary for Regulatory Activities) System Organ Class Term is written in bold.
| MedDRA System Organ Class Term MedDRA Preferred Term |
Intensity | GamTBvac n = 135 |
Placebo n = 45 |
||
|---|---|---|---|---|---|
| X (%) | Y | X (%) | Y | ||
| Total number of volunteers with AEs | Mild | 53 (39.3%) | 89 | 14 (31.1%) | 31 |
| Moderate | 5 (3.7%) | 9 | 1 (2.2%) | 1 | |
|
Blood and lymphatic system disorders Eosinophilia |
Mild | 2 (1.5%) | 3 | 1 (2.2%) | 1 |
| Mild | 0 (0.0%) | 0 | 1 (2.2%) | 1 | |
| Leukocytosis | Mild | 1 (0.7%) | 1 | 0 (0.0%) | 0 |
| Neutrophilia | Mild | 1 (0.7%) | 1 | 0 (0.0%) | 0 |
| Reticulocytosis | Mild | 1 (0.7%) | 1 | 0 (0.0%) | 0 |
| Gastrointestinal disorders | Mild | 1 (0.7%) | 2 | 0 (0.0%) | 0 |
| Nausea | Mild | 1 (0.7%) | 2 | 0 (0.0%) | 0 |
| General disorders and administration site conditions | Mild | 3 (2.2%) | 3 | 0 (0.0%) | 0 |
| Asthenia | Mild | 1 (0.7%) | 1 | 0 (0.0%) | 0 |
| Hyperthermia | Mild | 1 (0.7%) | 1 | 0 (0.0%) | 0 |
| Tissue infiltration Hepatobiliary disorders |
Mild | 1 (0.7%) | 1 | 0 (0.0%) | 0 |
| Mild | 0 (0.0%) | 0 | 1 (2.2%) | 1 | |
| Hyperbilirubinaemia | Mild | 0 (0.0%) | 0 | 1 (2.2%) | 1 |
| Infections and infestations | Mild | 1 (0.7%) | 1 | 1 (2.2%) | 1 |
| Moderate | 0 (0.0%) | 0 | 1 (2.2%) | 1 | |
| Herpes virus infection | Mild | 1 (0.7%) | 1 | 0 (0.0%) | 0 |
| Nasopharyngitis | Moderate | 0 (0.0%) | 0 | 1 (2.2%) | 1 |
| Rhinitis | Mild | 0 (0.0%) | 0 | 1 (2.2%) | 1 |
| Injury, poisoning, and procedural complications | Mild | 3 (2.2%) | 3 | 0 (0.0%) | 0 |
| Vaccination complication | Mild | 3 (2.2%) | 3 | 0 (0.0%) | 0 |
| Investigations | Mild | 41 (30.4%) | 66 | 13 (28.9%) | 27 |
| Moderate | 4 (3.0%) | 8 | 0 (0.0%) | 0 | |
| Alanine aminotransferase increased | Mild | 1 (0.7%) | 1 | 1 (2.2%) | 1 |
| Aspartate aminotransferase increased | Moderate | 1 (0.7%) | 1 | 0 (0.0%) | 0 |
| Bilirubin conjugated increased | Mild | 2 (1.5%) | 2 | 1 (2.2%) | 1 |
| Blood bilirubin increased | Mild | 8 (5.9%) | 10 | 5 (11.1%) | 6 |
| C-reactive protein increased | Moderate | 3 (2.2%) | 4 | 0 (0.0%) | 0 |
| Eosinophil count increased | Mild | 9 (6.7%) | 11 | 4 (8.9%) | 5 |
| Eosinophil percentage increased | Moderate | 2 (1.5%) | 3 | 0 (0.0%) | 0 |
| Hemoglobin decreased | Mild | 21 (15.6%) | 22 | 3 (6.7%) | 4 |
| Lymphocyte count decreased | Mild | 3 (2.2%) | 3 | 3 (6.7%) | 3 |
| Lymphocyte percentage decreased | Mild | 0 (0.0%) | 0 | 1 (2.2%) | 1 |
| Monocyte count increased | Mild | 1 (0.7%) | 1 | 1 (2.2%) | 1 |
| Neutrophil count decreased | Mild | 2 (1.5%) | 2 | 1 (2.2%) | 1 |
| Neutrophil count increased | Mild | 1 (0.7%) | 1 | 0 (0.0%) | 0 |
| pH urine increased | Mild | 1 (0.7%) | 1 | 0 (0.0%) | 0 |
| Protein total increased | Mild | 1 (0.7%) | 1 | 0 (0.0%) | 0 |
| White blood cell count decreased | Mild | 7 (5.2%) | 8 | 1 (2.2%) | 2 |
| Metabolism and nutrition disorders | Mild | 2 (1.5%) | 2 | 0 (0.0%) | 0 |
| Moderate | 1 (0.7%) | 1 | 0 (0.0%) | 0 | |
| Hyperkalemia | Mild | 2 (1.5%) | 2 | 0 (0.0%) | 0 |
| Moderate | 1 (0.7%) | 1 | 0 (0.0%) | 0 | |
| Musculoskeletal and connective tissue disorders | Mild | 3 (2.2%) | 3 | 0 (0.0%) | 0 |
| Myosclerosis | Mild | 3 (2.2%) | 3 | 0 (0.0%) | 0 |
| Nervous system disorders | Mild | 3 (2.2%) | 3 | 0 (0.0%) | 0 |
| Headache | Mild | 3 (2.2%) | 3 | 0 (0.0%) | 0 |
| Respiratory, thoracic, and mediastinal disorders | Mild | 2 (1.5%) | 2 | 1 (2.2%) | 1 |
| Cough | Mild | 1 (0.7%) | 1 | 0 (0.0%) | 0 |
| Respiratory disorder | Mild | 1 (0.7%) | 1 | 1 (2.2%) | 1 |
| Vascular disorders | Mild | 1 (0.7%) | 1 | 0 (0.0%) | 0 |
| Hypotension | Mild | 1 (0.7%) | 1 | 0 (0.0%) | 0 |