Table 2

Adverse events

Adverse effect categoryATG and GCSFATG onlyPlacebo
EventsPatientsEventsPatientsEventsPatients
Skin and subcutaneous tissue disorder65 (17.9)107 (24.1)74 (12.9)
All immune system disorders3321 (75.0)3823 (79.3)00 (0)
 Serum sickness only2020 (71.4)2121 (72.4)00 (0)
 Cytokine release syndrome only1110 (35.7)1714 (48.3)00 (0)
Musculoskeletal and connective tissue1410 (35.7)33 (10.3)65 (16.1)
CD4 lymphocyte decrease or other*4221 (75.0)4322 (75.9)43 (9.7)
General disorders and administration**167 (25.0)188 (27.6)11 (3.2)
Endocrine disorders11 (3.6)11 (3.4)73 (9.7)
Infections and infestations149 (32.1)97 (24.1)169 (29.0)
Gastrointestinal disorders75 (17.9)53 (10.3)66 (19.4)
Surgical and medical procedures11 (3.6)00 (0)11 (3.2)
Psychiatric disorders72 (7.1)11 (3.4)00 (0)
Injury, poisoning, and procedural complications41 (3.6)22 (6.9)55 (16.1)
Nervous system disorders44 (14.3)114 (13.8)52 (6.5)
Metabolism and nutrition disorders74 (14.3)42 (6.9)44 (12.9)
Vascular disorders00 (0)22 (6.9)11 (3.2)
Neoplasms: benign, malignant, and unspecified00 (0)11 (3.4)11 (3.2)
Respiratory, thoracic, and mediastinal22 (7.1)32 (6.9)11 (3.2)
Blood and lymphatic system disorder11 (3.6)11 (3.4)22 (6.5)
Cardiac disorders11 (3.6)00 (0)00 (0)
Ear and labyrinth disorders11 (3.6)00 (0)00 (0)
Total16128 (100)15229 (100)6731 (100)
  • Data are n or n (%).

  • *75% of the events were decreased lymphocytes. Others listed were decreased neutrophils, decreased white blood cells, increased alanine aminotransferase, increased alkaline phosphatase, and increased bilirubin.

  • **Mostly fever and flu-like symptoms.