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Table 2 Baseline demographic and disease characteristics (safety population)

From: A placebo-controlled, double-blind, dose-escalation study to assess the safety, tolerability and pharmacokinetics/pharmacodynamics of single and multiple intravenous infusions of AZD9773 in patients with severe sepsis and septic shock

  AZD9773 cohort 1
(50 U/kg)
(n= 8)
AZD9773 cohort 2
(250 U/kg)
(n= 9)
AZD9773 cohort 3
(250/50 U/kg) (n= 12)
AZD9773 cohort 4
(500/100 U/kg) (n= 10)
AZD9773 cohort 5
(750/250 U/kg)
(n= 8)
Placebo (n= 23) Total
(n= 70)
Mean age ± SD, years 53.0 ± 11.8 49.7 ± 15.0 55.1 ± 10.8 53.0 ± 17.9 63.5 ± 16.1 58.9 ± 17.4 56.1 ± 15.5
Male:female, n 6:2 5:4 5:7 3:7 2:6 11:12 32:38
Race, n (%)        
   Caucasian/white 7 (87.5) 8 (88.9) 11 (91.7) 9 (90.0) 7 (87.5) 20 (87.0) 62 (88.6)
   Black/African American 1 (12.5) 1 (11.1) 1 (8.3) 0 1 (12.5) 2 (8.7) 6 (8.6)
   Other 0 0 0 1 (10.0) 0 1 (4.3) 2 (2.9)
Shock, n (%)        
   Yes 5 (62.5) 6 (66.7) 9 (75.0) 9 (90.0) 7 (87.5) 20 (87.0) 56 (80.0)
   No 3 (37.5) 3 (33.3) 3 (25.0) 1 (10.0) 1 (12.5) 3 (13.0) 14 (20.0)
On ventilator, n (%)*        
   Yes 7 (87.5) 8 (100.0) 9 (81.8) 8 (88.9) 8 (100.0) 20 (87.0) 60 (89.6)
   No 1 (12.5) 0 2 (18.2) 1 (11.1) 0 3 (13.0) 7 (10.4)
   Missing 0 1 1 1 0 0 3
Shock + ventilator, n (%)* 4 (50.0) 5 (55.6) 7 (58.3) 7 (70.0) 7 (87.5) 17 (73.9) 47 (67.1)
Organ failures, n (%)**        
   0 1 (12.5) 0 1 (8.3) 0 0 0 2 (2.9)
   1 0 0 2 (16.7) 2 (20.0) 2 (25.0) 1 (4.3) 7 (10.0)
   2 2 (25.0) 3 (33.3) 2 (16.7) 1 (10.0) 1 (12.5) 5 (21.7) 14 (20.0)
   3 3 (37.5) 4 (44.4) 3 (25.0) 3 (30.0) 1 (12.5) 9 (39.1) 23 (32.9)
   ≥ 4 2 (25.0) 2 (22.2) 4 (33.3) 4 (40.0) 4 (50.0) 8 (34.8) 24 (34.3)
APACHE II score ( n = 8) ( n = 9) ( n = 12) ( n = 10) ( n = 7) ( n = 22) ( n = 68)
   Mean ± SD 28.4 ± 10.3 25.1 ± 7.8 26.3 ± 11.1 22.9 ± 9.0 25.1 ± 8.8 26.6 ± 8.0 25.9 ± 8.9
SOFA score ( n = 7) ( n = 8) ( n = 7) ( n = 8) ( n = 6) ( n = 20) ( n = 56)
   Mean ± SD 11.9 ± 4.3 10.9 ± 3.6 10.4 ± 3.4 11.5 ± 2.6 10.3 ± 3.6 10.7 ± 3.0 11.0 ± 3.2
TNF-α concentration, pg/mL ( n = 8) ( n = 8) ( n = 9) ( n = 9) ( n = 8) ( n = 23) ( n = 65)
   Median (range) 4.7
(1.3 to 48.8)
9.8
(2.7 to 54.3)
3.6
(1.3 to 14.2)
3.7
(1.3 to 8.2)
5.8
(1.3 to 18.3)
5.0
(1.6 to 61.7)
5.2
(1.3 to 61.7)
IL-6 concentration, pg/mL ( n = 7) ( n = 7) ( n = 9) ( n = 8) ( n = 7) ( n = 19) ( n = 57)
   Median (range) 465
(18 to 23,733)
189
(47 to 85,183)
215
(24 to 13,849)
1403
(135 to 16,168)
336
(194 to 94,207)
454
(28 to 153,600)
336
(18 to 153,600)
Procalcitonin level, ng/mL ( n = 8) ( n = 8) ( n = 10) ( n = 10) ( n = 6) ( n = 23) ( n = 65)
   Median (range) 28.5 (1.8 to 456.4) 4.8
(0.3 to 250.9)
4.0
(0.3 to 800.3)
16.5
(1.3 to 89.6)
15.1
(2.5 to 17.1)
14.7
(0.3 to 328.5)
14.2
(0.3 to 800.3)
   > 0.5 ng/mL, n (%) 8 (100) 7 (87.5) 7 (70.0) 10 (100) 6 (100) 22 (95.7) 60 (92.3)
Total fluid volume in 24 h prior to randomization, mL/kg ( n = 8) ( n = 9) ( n = 11) ( n = 7) ( n = 8) ( n = 23) ( n = 66)
   Median (range) 51.7
(23.8 to 167.6)
58.0
(6.4 to 158.6)
40.1
(11.1 to 183.4)
34.0
(17.2 to 196.8)
58.5
(29.3 to 434.1)
58.4
(8.7 to 373.5)
56.4
(6.4 to 434.1)
Relevant medical history, n (%)        
   Diabetes 1 (12.5) 4 (44.4) 4 (33.3) 3 (30.0) 3 (37.5) 7 (30.4) 22 (31.4)
   COPD 3 (37.5) 2 (22.2) 2 (16.7) 2 (20.0) 3 (37.5) 4 (17.4) 16 (22.9)
   Chronic renal failure 1 (12.5) 2 (22.2) 0 1 (10.0) 0 0 4 (5.7)
   Colon cancer 0 0 0 0 1 (12.5) 1 (4.3) 2 (2.9)
  1. *Percentages exclude patients with a missing assessment; **Number of organ failures (SOFA score components > 1); Reported in > 1 patient overall; COPD, chronic obstructive pulmonary disease. Note: One patient in AZD9773 cohort 1 was recorded as having no organ failure as study drug was administered outside the protocol-defined time limit. However, this resulted from a data entry error that was not amended in the clinical database; the patient did in fact receive study drug within the defined time limit. One patient in AZD9773 cohort 3 was recorded as having no organ failure as they received study drug outside the protocol-defined time limit; inclusion of this patient was a protocol deviation