Table 6 Serious adverse events (Safety Set)
JTA-100/2a | JTA-200/2a | JTA-200/4a | referencea | |||||
|---|---|---|---|---|---|---|---|---|
m | n (%) | m | n (%) | m | n (%) | m | n (%) | |
At least one serious AE | 4 | 4 (9.8) | 5 | 2 (4.9) | 1 | 1 (2.4) | 1 | 1 (2.4) |
Gastrointestinal Disorders | 2 | 2 (4.9) | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Barrett’s Esophagus | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Diarrhea | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Hernial Eventration | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Infections and Infestations | 0 | 0 (0.0) | 3 | 1 (2.4) | 1 | 1 (2.4) | 0 | 0 (0.0) |
Osteomyelitis Acute | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Osteomyelitis Chronic | 0 | 0 (0.0) | 2 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Pneumonia | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) |
Injury, Poisoning and Procedural Complications | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) |
Alcohol Poisoning | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) |
Musculoskeletal and Connective Tissue Disorders | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Arthralgia | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Neoplasms Benign, Malignant and Unspecified (Incl Cysts and Polyps) | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Squamous Cell Carcinoma of Lung | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Reproductive System and Breast Disorders | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Rectocele | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) |