Table 2.

Distribution of patient-and HCP-reported ADRs

PatientHCPp-value
High Level Group TermBurden
(1-5)
Reports
(%)
HCP contact
(%)
Reports
(%)
All patient vs HCP reportsHCP contact vs HCP reports
Administration site reactions1.7402 (20.3)93 (11.1)20 (2.9)<.001<.001
Infections - pathogen unspecified2.9229 (11.6)130 (15.5)93 (13.7)0.1530.344
Epidermal and dermal conditions2.6218 (11.0)96 (11.4)111 (16.3)<.0010.007
General system disorders NEC2.8175 (8.9)82 (9.8)52 (7.7)0.3820.172
Gastrointestinal signs and symptoms2.481 (4.1)17 (2.0)29 (4.3)0.8240.015
Respiratory disorders NEC2.477 (3.9)33 (3.9)26 (3.8)1.01.0
Headaches2.955 (2.8)23 (2.7)19 (2.8)1.01.0
Joint disorders3.355 (2.8)32 (3.8)3 (0.4)0.0930.006
Respiratory tract signs and symptoms2.247 (2.4)22 (2.6)7 (1.0)0.0390.036
Skin appendage conditions3.044 (2.2)14 (1.7)12 (1.8)0.5381.0
Musculoskeletal and connective tissue disorders NEC3.140 (2.0)16 (1.9)4 (0.6)0.0090.039
Oral soft tissue conditions2.433 (1.7)12 (1.4)7 (1.0)0.2770.644
Gastrointestinal motility and defaecation conditions2.629 (1.5)12 (1.4)16 (2.4)0.1230.186
Ocular infections, irritations and inflammations3.129 (1.5)22 (2.6)4 (0.6)0.1060.002
Therapeutic and nontherapeutic effects (excl toxicity)2.927 (1.4)16 (1.9)3 (0.4)0.0570.010
Other2.9436 (22.1)221 (26.3)273 (40.2)<.001<.001