Table 2

Safety summary (safety population)

Frequency of events (percentage of overall group)*FemaleMale
Placebo
(N=23)
GSK2881078
(N=24)
Placebo
(N=24)
GSK2881078
(N=25)
Any event19 (83%)20 (83%)17 (71%)19 (76%)
Any severe AEs1 (4%)3 (13%)3 (13%)2 (8%)
AEs leading to withdrawal02 (8%)5 (21%)4 (16%)
Drug-related AEs leading to withdrawal01 (4%)03 (12%)
Drug-related AEs1 (4%)3 (13%)1 (4%)4 (16%)
Any SAEs1 (4%)2 (8%)2 (8%)0
Drug-related SAEs0000
Any AEs of special interest3 (13%)6 (25%)5 (21%)3 (12%)
Fatal SAEs0000
SAEs
 Diverticulitis001 (4%)0
 Infective exacerbation of COPD1 (4%)000
 Myocardial infarction01 (4%)00
 Cholecystitis01 (4%)00
 Adenocarcinoma of colon001 (4%)0
Frequent AEs*
 COPD6 (26%)7 (29%)2 (8%)3 (12%)
 Nasopharyngitis5 (22%)2 (8%)1 (4%)1 (4%)
 Arthralgia03 (13%)2 (8%)2 (8%)
 Muscle spasms1 (4%)2 (8%)03 (12%)
 Back pain03 (13%)02 (8%)
 Contusion3 (13%)1 (4%)00
 Headache02 (8%)02 (8%)
 ALT increase01 (4%)02 (8%)
 Epistaxis002 (8%)1 (4%)
 Hypertension01 (4%)2 (8%)0
 Musculoskeletal chest pain01 (4%)02 (8%)
 Blood 25-hydroxycholecalciferol decreased02 (8%)00
 Hypotension002 (8%)0
  • *Frequent AE is defined as occurring in a minimum of 2 patients of any sex for either arm.

  • AE, adverse event; ALT, alanine aminotransferase; COPD, chronic obstructive pulmonary disease; SAE, serious adverse events.