Table 5 Adverse events related to study treatment (Safety Set)
JTA-100/2a | JTA-200/2a | JTA-200/4a | referencea | |||||
|---|---|---|---|---|---|---|---|---|
m | n (%) | m | n (%) | m | n (%) | m | n (%) | |
At least one AE related to study treatment | 5 | 3 (7.3) | 12 | 8 (19.5) | 15 | 12 (29.3) | 17 | 11 (26.8) |
Musculoskeletal and Connective Tissue Disorders | 1 | 1 (2.4) | 1 | 1 (2.4) | 3 | 3 (7.3) | 6 | 5 (12.2) |
Arthralgia | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) | 4 | 3 (7.3) |
Osteoarthritisb | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) | 1 | 1 (2.4) |
Joint Stiffness | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Pain in Extremity | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) |
Plantar Fasciitis | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) |
Tendonitis | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) |
General Disorders and Administration Site Conditions | 0 | 0 (0.0) | 3 | 3 (7.3) | 3 | 3 (7.3) | 3 | 3 (7.3) |
Injection Site Pain | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) | 2 | 2 (4.9) |
Fatigue | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) | 1 | 1 (2.4) |
Application Site Edema | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Condition Aggravated | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Influenza Like Illness | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Thirst | 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) | 1 | 1 (2.4) | 3 | 3 (7.3) | 1 | 1 (2.4) |
Procedural Hypotension | 0 | 0 (0.0) | 0 | 0 (0.0) | 3 | 3 (7.3) | 0 | 0 (0.0) |
Delayed Recovery from Anesthesia | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Procedural Pain | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) |
Skin and Subcutaneous Tissue Disorders | 1 | 1 (2.4) | 1 | 1 (2.4) | 3 | 3 (7.3) | 0 | 0 (0.0) |
Eczema | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) |
Erythema | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Hyperkeratosis | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Skin Irritation | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) |
Skin Lesion | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) |
Investigations | 2 | 1 (2.4) | 1 | 1 (2.4) | 0 | 0 (0.0) | 2 | 2 (4.9) |
Blood Creatine Phosphokinase Increased | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 2 | 2 (4.9) |
Amylase Increased | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Blood Pressure Decreased | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Blood Triglycerides Increased | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Gastrointestinal Disorders | 0 | 0 (0.0) | 1 | 1 (2.4) | 1 | 1 (2.4) | 1 | 1 (2.4) |
Abdominal Pain | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) |
Diarrhea | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Melaena | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) |
Cardiac Disorders | 0 | 0 (0.0) | 1 | 1 (2.4) | 1 | 1 (2.4) | 0 | 0 (0.0) |
Supraventricular Extrasystoles | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) |
Tachycardia | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) |
Surgical and Medical Procedures | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) |
Joint Injection | 1 | 1 (2.4) | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) |
Ear and Labyrinth Disorders | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) |
Vertigo | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) |
Infections and Infestations | 0 | 0 (0.0) | 3 | 1 (2.4) | 0 | 0 (0.0) | 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) |
Nervous System Disorders | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) |
Headache | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) |
Psychiatric Disorders | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) |
Major Depression | 0 | 0 (0.0) | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) |
Vascular Disorders | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) |
Hypotension | 0 | 0 (0.0) | 0 | 0 (0.0) | 1 | 1 (2.4) | 0 | 0 (0.0) |