Table 3

Summary of adverse events (AEs)

Danegaptide high (n=184)
n (%) E
Danegaptide low (n=206)
n (%) E
Placebo (n=195)
n (%) E
P values
Overall difference between
arms (Poisson E/N)
All AEs170 (92.4) 897197 (95.6) 949178 (91.3) 9130.461
Deaths3 (1.6) 33 (1.5) 34 (2.1) 40.899
Serious AEs31 (16.8) 3943 (20.9) 6142 (21.5) 550.220
AEs leading to discontinuation0 (0.0) 01 (0.5) 10 (0.0) 0
Severity of AEs
Mild158 (85.9) 621188 (91.3) 623164 (84.1) 646
Moderate91 (49.5) 252105 (51.0) 283100 (51.3) 245
Severe15 (8.2) 2427 (13.1) 4316 (8.2) 22
Relationship
Possible9 (4.9) 1311 (5.3) 1610 (5.1) 14
Probable1 (0.5) 11 (0.5) 11 (0.5) 2
Unlikely169 (91.8) 880196 (95.1) 931178 (91.3) 896
Not assessable3 (1.6) 31 (0.5) 11 (0.5) 1
Most frequent AEs*
Blood creatinine increased21 (11.4) 2223 (11.2) 2521 (10.8) 21
Chest discomfort20 (10.9) 2526 (12.6) 2721 (10.8) 25
Chest pain29 (15.8) 3230 (14.6) 3435 (17.9) 39
Constipation19 (10.3) 2025 (12.1) 2722 (11.3) 22
Contusion11 (6.0) 1113 (6.3) 1322 (11.3) 22
Dizziness15 (8.2) 1623 (11.2) 2323 (11.8) 24
Dyspnoea44 (23.9) 5250 (24.3) 5638 (19.5) 41
Fatigue37 (20.1) 3730 (14.6) 3132 (16.4) 33
Headache19 (10.3) 2113 (6.3) 1310 (5.1) 11
Hypotension29 (15.8) 2932 (15.5) 3326 (13.3) 26
Insomnia34 (18.5) 3431 (15.0) 3134 (17.4) 34
  • The DSMB met to review data safety packages non-blinded when day 30 data were available for 30, 200 and 400 patients.

  • *AEs included in the table are AEs reported by  ≥10% of patients in any treatment group.

  • DSMB, Data Safety Monitoring Board; E, number of AEs; n, number of patients with AE; N, number of patients in safety analysis set; %, percentage of patients with AE.