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Table 3 Treatment-emergent adverse events under forced upward titration conditions

From: Safety and Tolerability of Manual Push Administration of Subcutaneous IgPro20 at High Infusion Rates in Patients with Primary Immunodeficiency: Findings from the Manual Push Administration Cohort of the HILO Study

  0.5 mL/min/site (N = 16; Inf = 220) 1 mL/min/site (N = 16; Inf = 208) 2 mL/min/site (N = 14; Inf = 198)
n (%) E (rate) n (%) E (rate) n (%) E (rate)
Any TEAE 5 (31.3) 14 (0.064) 9 (56.3) 23 (0.111) 7 (50.0) 16 (0.081)
  Treatment-related 3 (18.8) 9 (0.041) 5 (31.3) 18 (0.087) 3 (21.4) 6 (0.030)
Intensity of TEAEs
  Mild
  Moderate
  Severe
5 (31.3)
0
0
14 (0.064)
0
0
8 (50.0)
0
1 (6.3)a
22 (0.106)
0
1 (0.005)a
7 (50.0)
3 (21.4)
0
13 (0.066)
3 (0.015)
0
Serious TEAEs 0 0 1 (6.3)a 1 (0.005)a 0 0
  Treatment-related 0 0 0 0 0 0
Deaths 0 0 0 0 0 0
Study discontinuation due to TEAE 0 0 1 (6.3)a 1 (0.005)a 0 0
  Treatment-related 0 0 0 0 0 0
Study drug withdrawal due to TEAE 0 0 1 (6.3)a 1 (0.005)a 0 0
  Treatment-related 0 0 0 0 0 0
Local TEAEs 3 (18.8) 6 (0.027) 4 (25.0) 17 (0.082) 2 (14.3) 5 (0.025)
  Treatment-related 2 (12.5) 5 (0.023) 4 (25.0) 17 (0.082) 2 (14.3) 5 (0.025)
Most common (> 1 event at any flow rate) TEAEs by preferred term
  Injection site pain 1 (6.3) 4 (0.018) 2 (12.5) 4 (0.019) 1 (7.1) 1 (0.005)
  Injection site bruising 0 0 1 (6.3) 2 (0.010) 1 (7.1) 3 (0.015)
  Injection site swelling 1 (6.3) 1 (0.005) 1 (6.3) 3 (0.014) 1 (7.1) 1 (0.005)
  Injection site erythema 0 0 1 (6.3) 3 (0.014) 0 0
 Injection site discoloration 0 0 1 (6.3) 2 (0.010) 0 0
 Injection site pruritus 0 0 1 (6.3) 2 (0.010) 0 0
  Diarrhea 2 (12.5) 3 (0.014) 1 (6.3) 1 (0.005) 0 0
  Nausea 2 (12.5) 3 (0.014) 0 0 0 0
  Upper respiratory tract infection 0 0 0 0 2 (14.3) 2 (0.010)
Most common (> 1 event at any flow rate) treatment-related TEAEs by preferred term
  Injection site pain 1 (6.3) 4 (0.018) 2 (12.5) 4 (0.019) 1 (7.1) 1 (0.005)
  Injection site bruising 0 0 1 (6.3) 2 (0.010) 1 (7.1) 3 (0.015)
  Injection site swelling 1 (6.3) 1 (0.005) 1 (6.3) 3 (0.014) 1 (7.1) 1 (0.005)
  Injection site erythema 0 0 1 (6.3) 3 (0.014) 0 0
  Injection site discoloration 0 0 1 (6.3) 2 (0.010) 0 0
  Injection site pruritus 0 0 1 (6.3) 2 (0.010) 0 0
  Diarrhea 1 (6.3) 2 (0.009) 1 (6.3) 1 (0.005) 0 0
  Nausea 1 (6.3) 2 (0.009) 0 0 0 0
  1. Rate = number of events/total number of infusions prior to patient’s start date of non-response
  2. Excludes TEAEs occurring after non-response
  3. E, number of events; Inf, infusions; n, number of patients; TEAE, treatment-emergent adverse event
  4. aOne patient with a documented medical history of depression had a severe, unrelated serious TEAE (suicide attempt) that led to study discontinuation after administering 5 of 8 planned infusions at the 1.0-mL/min rate