Table 2

Summary of patients with TEAE

Patients with TEAE* in part 1Subcutaneous golimumab (N=3357), n (%)
One or more TEAE1881 (56.0)
TEAE possibly or probably related to study medication943 (28.1)
TEAE leading to early withdrawal145 (4.3)
Deaths6 (0.2)†
Injection site reactions23 (0.7)
Clinically significant abnormal lab values163 (4.9)
Serious TEAE190 (5.7)
 Infections and infestations58 (1.7)
 Injury, poisoning and procedural complications26 (0.8)
 Musculoskeletal and connective tissue disorders25 (0.7)
 Cardiac disorders15 (0.4)
 Neoplasms benign, malignant and unspecified (including cysts and polyps)15 (0.4)
 Respiratory, thoracic and mediastinal disorders15 (0.4)
 Gastrointestinal disorders14 (0.4)
 Nervous system disorders11 (0.3)
 General disorders and administration site conditions10 (0.3)
 Vascular disorders9 (0.3)
 Renal and urinary disorders7 (0.2)
 Metabolism and nutrition disorders6 (0.2)
 Hepatobiliary disorders4 (0.1)
 Skin and subcutaneous tissue disorders4 (0.1)
 Surgical and medical procedures4 (0.1)
 Blood and lymphatic system disorders3 (0.1)
 Immune system disorders3 (0.1)
 Investigations3 (0.1)
 Psychiatric disorders3 (0.1)
 Reproductive system and breast disorders3 (0.1)
 Eye disorders2 (0.1)
 Ear and labyrinth disorders1 (0.03)
Patients with TEAE in part 2IV+SC golimumab (N=245) n (%)Subcutaneous golimumab (N=255) n (%)
One or more TEAE133 (54.3)127 (49.8)
TEAE possibly or probably related to study medication65 (26.5)57 (22.4)
TEAE leading to early withdrawal12 (4.9)6 (2.4)
Deaths1 (0.4)0
Injection site reactions1 (0.4)0
Clinically significant abnormal lab values13 (5.3)16 (6.3)
Serious TEAE17 (6.9)6 (2.4)
 Infections and infestations5 (2.0)2 (0.8)
 Musculoskeletal and connective tissue disorders3 (1.2)0
 Injury, poisoning, and procedural complications3 (1.2)1 (0.4)
 Respiratory, thoracic and mediastinal disorders2 (0.8)0
 Gastrointestinal disorders2 (0.8)0
 Hepatobiliary disorders1 (0.4)0
 General disorders and administration site conditions1 (0.4)0
 Cardiac disorders1 (0.4)0
 Neoplasms benign, malignant and unspecified1 (0.4)2 (0.8)
 Nervous system disorders1 (0.4)0
 Skin and subcutaneous tissue disorders01 (0.4)
 Investigations01 (0.4)
  • *A TEAE was defined as an adverse event occurring during the treatment period if it started on or after the first dose of study medication, and up to 30 days after the last dose of study medication, or if it was present before the first dose of study medication, but increased in severity during the treatment period.

  • †Four additional events that led to death occurred in patients more than 30 days after their last dose of study medication.

  • IV+SC, intravenous plus subcutaneous; TEAE, treatment-emergent adverse event.