Table 3

Adverse events grades 3 and 4

Adverse effect categoryATG and GCSFATG onlyPlacebo
EventsPatientsEventsPatientsEventsPatients
All immune system disorders1412 (42.9)1515 (51.7)00 (0)
 Serum sickness only1212 (42.9)1515 (51.7)00 (0)
 Cytokine release syndrome only22 (7.1)00 (0)00 (0)
CD4 lymphocyte decrease or other*2418 (64.3)2317 (58.6)00 (0)
General disorders and administration**42 (7.1)11 (3.4)11 (3.2)
Endocrine disorders00 (0)00 (0)51 (3.2)
Infections and infestations00 (0)00 (0)11 (3.2)
Gastrointestinal disorders11 (3.6)00 (0)00 (0)
Surgical and medical procedures00 (0)00 (0)11 (3.2)
Psychiatric disorders31 (3.6)00 (0)00 (0)
Injury, poisoning, and procedural complications21 (3.6)11 (3.4)11 (3.2)
Nervous system disorders11 (3.6)11 (3.4)11 (3.2)
Metabolism and nutrition disorders32 (7.1)00 (0)22 (6.5)
Neoplasms: benign, malignant, and unspecified00 (0)11 (3.4)00 (0)
Blood and lymphatic system disorder00 (0)11 (3.4)00 (0)
Total522843291231
  • Data are n or n (%).

  • *Mostly 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.