TABLE 5.
Potentially adenovector-related clinical pathology parameters by study
| SERUM CHEMISTRIES | Treated | Controlsa | |||||||
|---|---|---|---|---|---|---|---|---|---|
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| Parameter | Study | Product | Timepoint | Gender | Direction | Mean | S.D.b | Mean | S.D. |
| Cholesterolc | D | 14 | SD3 | M | ↑ | 102 | 20.81 | 80 | 18.66 |
| F | ↑ | 124 | 32.06 | 92 | 25.61 | ||||
| E | 18 | M | ↑ | 130.8 | 28.63 | 73.3 | 10.61 | ||
| F | ↑ | 166.78 | 36.32 | 104.7 | 20.22 | ||||
| 22 | M | ↑ | 117.1 | 10.81 | 73.3 | 10.61 | |||
| F | ↑ | 135.8 | 21.7 | 104.7 | 20.22 | ||||
| G | 27 | SD4 | M | ↓ | 64 | 5.33 | 84.71 | 14.97 | |
| Triglyceridesd | D | 14 | SD3 | M | ↑ | 287 | 127.87 | 159 | 58.62 |
| F | ↑ | 188 | 53.96 | 126 | 42.01 | ||||
| 9, 14 | SD86 | M | ↑ | 744 | 570.96 | 192 | 178.16 | ||
| E | 18 | SD3 | M | ↑ | 404.9 | 198.73 | 153.9 | 48.28 | |
| F | ↑ | 318.78 | 222.7 | 138.6 | 54.81 | ||||
| 22 | M | ↑ | 297 | 107.63 | 153.9 | 48.28 | |||
| F | ↑ | 216 | 30.61 | 138.6 | 54.81 | ||||
| G | 27 | SD4 | M | ↑ | 187.5 | 72.8 | 126.8 | 44.59 | |
| SD30 | M | ↑ | 145.6 | 66.18 | 82.9 | 22.2 | |||
| Globuline | D | 14 | SD3 | M | ↑ | 2.3 | 0.15 | 2 | 0.12 |
| F | ↑ | 2.2 | 0.1 | 2 | 0.1 | ||||
| SD24 | M | ↑ | 2.2 | 0.13 | 2 | 0.08 | |||
| F | ↑ | 2.2 | 0.12 | 1.9 | 0.1 | ||||
| SD36 | M | ↑ | 2.2 | 0.23 | 1.9 | 0.14 | |||
| 9, 14 | SD86 | F | ↑ | 2.4 | 0.16 | 2.1 | 0.24 | ||
| SD108 | M | ↑ | 2.3 | 0.18 | 2.1 | 0.16 | |||
| F | ↑ | 2.3 | 0.08 | 2.2 | 0.18 | ||||
| E | 18 | SD3 | M | ↑ | 2.42 | 0.21 | 1.96 | 0.12 | |
| F | ↑ | 2.5 | 0.3 | 2.03 | 0.19 | ||||
| 22 | M | ↑ | 2.3 | 0.21 | 1.96 | 0.12 | |||
| F | ↑ | 2.26 | 0.19 | 2.03 | 0.19 | ||||
| 18 | SD24 | M | ↑ | 1.85 | 0.16 | 1.43 | 0.21 | ||
| F | ↑ | 1.93 | 0.16 | 1.55 | 0.11 | ||||
| 22 | M | ↑ | 1.71 | 0.13 | 1.43 | 0.21 | |||
| F | ↑ | 1.82 | 0.14 | 1.55 | 0.11 | ||||
| 18 | SD45 | M | ↑ | 2.02 | 0.15 | 1.51 | 0.17 | ||
| F | ↑ | 2.07 | 0.14 | 1.68 | 0.13 | ||||
| 22 | M | ↑ | 2.05 | 0.12 | 1.51 | 0.17 | |||
| F | ↑ | 2.08 | 0.12 | 1.68 | 0.13 | ||||
| 18 | SD57 | M | ↑ | 1.66 | 0.09 | 1.34 | 0.011 | ||
| F | ↑ | 1.58 | 0.19 | 1.42 | 0.16 | ||||
| 22 | M | ↑ | 1.8 | 0.12 | 1.34 | 0.11 | |||
| F | 25, 21 | SD90 | M | ↑ | 2.43 | 0.16 | 2.07 | 0.14 | |
| F | ↑ | 2.59 | 0.13 | 2.2 | 0.22 | ||||
| SD120 | F | ↑ | 2.28 | 0.15 | 2.08 | 0.11 | |||
| G | 27 | SD4 | M | ↑ | 2.26 | 0.11 | 2.1 | 0.14 | |
| SD30 | M | ↑ | 2.22 | 0.08 | 2 | 0.08 | |||
| F | ↑ | 2.32 | 0.27 | 2.05 | 0.1 | ||||
| SD45 | M | ↑ | 2.16 | 0.15 | 1.96 | 0.09 | |||
| F | ↑ | 2.2 | 0.07 | 2 | 0.16 | ||||
| SD57 | F | ↑ | 2.38 | 0.19 | 2.08 | 0.08 | |||
| A/G ratiof | D | 14 | SD3 | M | ↓ | 1.6 | 0.11 | 2 | 0.19 |
| F | ↓ | 1.8 | 0.15 | 1.9 | 0.11 | ||||
| SD24 | M | ↓ | 1.8 | 0.11 | 2 | 0.15 | |||
| F | ↓ | 1.47 | 0.11 | 2 | 0.07 | ||||
| SD36 | M | ↓ | 1.7 | 0.2 | 2 | 0.21 | |||
| 9, 14 | SD86 | F | ↓ | 1.7 | 0.18 | 2.1 | 0.16 | ||
| E | 18 | SD3 | M | ↓ | 1.53 | 0.13 | 1.88 | 0.16 | |
| F | ↓ | 1.47 | 0.16 | 1.83 | 0.22 | ||||
| 22 | M | ↓ | 1.66 | 0.18 | 1.88 | 0.16 | |||
| F | ↓ | 1.59 | 0.18 | 1.83 | 0.22 | ||||
| 18 | SD24 | M | ↓ | 2.17 | 0.22 | 2.95 | 0.56 | ||
| F | ↓ | 2.06 | 0.24 | 2.61 | 0.17 | ||||
| 22 | M | ↓ | 2.4 | 0.24 | 2.95 | 0.56 | |||
| F | ↓ | 2.18 | 0.22 | 2.61 | 0.17 | ||||
| 18 | SD45 | M | ↓ | 1.97 | 0.18 | 2.77 | 0.37 | ||
| F | ↓ | 1.95 | 0.19 | 2.33 | 0.18 | ||||
| 22 | M | ↓ | 2.05 | 0.16 | 2.77 | 0.37 | |||
| F | ↓ | 1.87 | 0.16 | 2.33 | 0.18 | ||||
| 18 | SD57 | M | ↓ | 2.42 | 0.21 | 2.99 | 0.2 | ||
| F | ↓ | 2.23 | 0.09 | 2.77 | 0.23 | ||||
| 22 | F | ↓ | 2.45 | 0.16 | 2.77 | 0.23 | |||
| F | 25, 21 | SD90 | M | ↓ | 1.71 | 0.12 | 2.07 | 0.18 | |
| F | ↓ | 1.52 | 0.09 | 1.86 | 0.09 | ||||
| SD120 | F | ↓ | 1.72 | 0.1 | 1.91 | 0.11 | |||
| G | 27 | SD30 | M | ↓ | 1.74 | 0.08 | 1.84 | 0.08 | |
| F | ↓ | 1.73 | 0.15 | 1.84 | 0.14 | ||||
| SD45 | M | ↓ | 1.75 | 0.15 | 1.92 | 0.1 | |||
| F | ↓ | 1.62 | 0.16 | 1.82 | 0.09 | ||||
| SD57 | F | ↓ | 1.65 | 0.15 | 1.94 | 0.04 | |||
| HEMATOLOGIES | |||||||||
| Hemoglobing | D | 14 | SD3 | M | ↓ | 11.9 | 0.48 | 13.1 | 0.71 |
| SD24 | M | ↓ | 12 | 0.9 | 13.2 | 0.67 | |||
| 9,14 | SD108 | M | ↓ | 12.7 | 0.64 | 13.4 | 1.55 | ||
| E | 22 | SD -4 | M | ↓ | 12.53 | 0.75 | 13.3 | 0.54 | |
| 18 | SD3 | M | ↓ | 11.54 | 0.66 | 12.35 | 0.81 | ||
| 22 | M | ↓ | 10.92 | 0.75 | 12.35 | 0.81 | |||
| F | ↓ | 11.16 | 0.5 | 12.07 | 0.58 | ||||
| 18 | SD24 | M | ↓ | 12.96 | 0.66 | 13.92 | 0.5 | ||
| 22 | M | ↓ | 12.91 | 0.64 | 13.92 | 0.5 | |||
| 18 | SD45 | M | ↓ | 14.18 | 0.56 | 14.75 | 0.59 | ||
| 22 | M | ↓ | 13.94 | 0.56 | 14.75 | 0.59 | |||
| F | ↓ | 13.84 | 0.37 | 14.41 | 0.65 | ||||
| F | 25, 21 | SD90 | M | ↓ | 13.2 | 0.53 | 14.47 | 0.95 | |
| F | ↓ | 12.79 | 0.78 | 13.77 | 0.67 | ||||
| SD108 | M | ↓ | 13.16 | 0.42 | 13.92 | 0.49 | |||
| G | 27 | SD30 | F | ↓ | 13.35 | 0.56 | 14.04 | 0.59 | |
| SD45 | M | ↓ | 13.7 | 0.6 | 14.82 | 0.31 | |||
| F | ↓ | 13.06 | 0.75 | 14.34 | 0.61 | ||||
| SD57 | F | ↑ | 14.22 | 0.65 | 13.44 | 0.38 | |||
| Hematocrith | D | 14 | SD3 | M | ↓ | 39.2 | 1.83 | 43.9 | 2.69 |
| SD24 | M | ↓ | 38.6 | 3.38 | 42.1 | 2.32 | |||
| 9, 14 | SD120 | M | ↓ | 44.1 | 1.28 | 47.1 | 1.46 | ||
| E | 18 | SD -4 | M | ↓ | 37.52 | 1.93 | 39.69 | 1.58 | |
| 22 | SD3 | M | ↓ | 33.11 | 1.91 | 35.55 | 2.05 | ||
| F | ↓ | 32.41 | 3.45 | 35.41 | 1.91 | ||||
| 18 | M | ↓ | 31.41 | 2.03 | 35.55 | 2.05 | |||
| F | ↓ | 32.03 | 1.58 | 35.41 | 1.91 | ||||
| 22 | SD24 | M | ↓ | 38.43 | 2.02 | 40.46 | 1.42 | ||
| 18 | M | ↓ | 37.89 | 1.92 | 40.46 | 1.42 | |||
| 18 | SD45 | M | ↓ | 39.56 | 1.29 | 41.67 | 1.87 | ||
| F | 25, 21 | SD -6 | M | ↑ | 36.66 | 1.16 | 35.3 | 1.39 | |
| F | ↓ | 33.76 | 1.91 | 36.02 | 1.91 | ||||
| SD90 | M | ↓ | 39.27 | 1.59 | 41.99 | 2.88 | |||
| F | ↓ | 37.79 | 2.06 | 40.28 | 1.82 | ||||
| SD108 | M | ↓ | 38.66 | 1.25 | 40.92 | 1.62 | |||
| G | 28 | SD30 | F | ↓ | 39.51 | 1.49 | 41.02 | 2.27 | |
| SD45 | M | ↓ | 40.46 | 1.65 | 43.28 | 0.79 | |||
| F | ↓ | 38.42 | 2.06 | 42.12 | 1.47 | ||||
| Plateletsi | D | 14 | SD3 | F | ↓ | 303 | 104.75 | 425 | 128.03 |
| 9, 14 | SD86 | M | ↓ | 232 | 17.16 | 354 | 67 | ||
| F | ↓ | 172 | 46.64 | 356 | 101.49 | ||||
| E | 18 | SD3 | M | ↓ | 224.67 | 154.19 | 394 | 95.96 | |
| F | ↓ | 201.3 | 89.58 | 480.8 | 123.48 | ||||
| 22 | M | ↓ | 261.67 | 138.01 | 394 | 95.96 | |||
| F | ↓ | 272.56 | 114.52 | 480.8 | 123.48 | ||||
| F | 25, 21 | SD90 | M | ↑ | 991.8 | 138.03 | 473.9 | 66.57 | |
| F | ↑ | 1037.6 | 164.13 | 495.22 | 127.88 | ||||
| G | 27 | SD45 | F | ↓ | 618.7 | 149.08 | 809.9 | 155.31 | |
| Mean | D | 14 | SD3 | M | ↑ | 8 | 1.29 | 6.2 | 1.66 |
| Platelet | E | 18 | M | ↑ | 8.36 | 2.38 | 6.08 | 0.18 | |
| Volumej | F | ↑ | 8.49 | 2.77 | 6.46 | 0.46 | |||
| 22 | M | ↑ | 7.17 | 0.9 | 6.08 | 0.18 | |||
| F | ↑ | 7.36 | 0.92 | 6.46 | 0.46 | ||||
| 18 | SD24 | M | ↑ | 6.75 | 1.45 | 5.74 | 0.3 | ||
| 22 | M | ↑ | 6.32 | 0.36 | 5.74 | 0.3 | |||
| F | 25, 21 | SD90 | M | ↑ | 6.76 | 0.46 | 6.38 | 0.52 | |
| COAGULATION | |||||||||
| Activated | D | 14 | SD24 | F | ↑ | 83.71 | 7.65 | 73.35 | 10.95 |
| Partial | 9, 14 | SD86 | F | ↑ | 86.66 | 9.41 | 75 | 11.97 | |
| Thromboplastin | E | 18 | SD3 | M | ↑ | 105.96 | 27.18 | 54.02 | 10.85 |
| Timek | F | ↑ | 119.27 | 15.85 | 85.93 | 19.77 | |||
| 22 | M | ↑ | 114.06 | 17.65 | 54.02 | 10.85 | |||
| F | ↑ | 117.5 | 6.52 | 85.93 | 19.77 | ||||
| 18 | SD24 | F | ↑ | 107.19 | 12.35 | 84.32 | 14.21 | ||
| SD45 | M | ↑ | 108.11 | 7.65 | 81.11 | 14.94 | |||
| F | ↑ | 104.88 | 19.47 | 85.15 | 15.44 | ||||
| 22 | M | ↑ | 105.47 | 14.17 | 81.11 | 14.94 | |||
| F | ↑ | 103.81 | 8.87 | 85.15 | 15.44 | ||||
| F | 25, 21 | SD90 | M | ↑ | 135.1 | 17.4 | 86.51 | 8.13 | |
| F | ↑ | 132.5 | 15.83 | 93.69 | 17.85 | ||||
| SD108 | M | ↑ | 100.72 | 10.29 | 81.76 | 9.18 | |||
| G | 27 | Pre-dose | F | ↓ | 79.02 | 10.35 | 87.37 | 6.76 | |
| SD30 | F | ↑ | 112.9 | 15.21 | 96.93 | 16.31 | |||
| SD45 | M | ↑ | 117.6 | 12.58 | 96.48 | 8.1 | |||
| Prothrombin | D | 14 | SD3 | M | ↓ | 8.69 | 0.8 | 8.93 | 0.9 |
| Timel | F | ↓ | 8.64 | 0.8 | 8.93 | 0.7 | |||
| SD24 | M | ↓ | 8.96 | 0.12 | 9.17 | 0.12 | |||
| F | ↓ | 9.02 | 0.1 | 9.27 | 0.14 | ||||
| E | 18 | SD3 | M | ↓ | 5.88 | 0.03 | 6.17 | 0.09 | |
| F | ↓ | 5.88 | 0.06 | 6.23 | 0.11 | ||||
| 22 | SD3 | M | ↓ | 5.87 | 0.05 | 6.17 | 0.09 | ||
| F | ↓ | 5.9 | 0.06 | 6.23 | 0.11 | ||||
| 18 | SD24 | M | ↓ | 6.02 | 0.09 | 6.5 | 0.12 | ||
| F | ↓ | 6.02 | 0.09 | 6.57 | 0.24 | ||||
| 22 | M | ↓ | 6.05 | 0.12 | 6.5 | 0.12 | |||
| F | ↓ | 6.05 | 0.14 | 6.57 | 0.24 | ||||
| 18 | SD45 | M | ↓ | 6.27 | 0.14 | 6.56 | 0.12 | ||
| F | ↓ | 6.26 | 0.16 | 6.62 | 0.25 | ||||
| 22 | M | ↓ | 6.3 | 0.12 | 6.56 | 0.12 | |||
| F | ↓ | 6.33 | 0.09 | 6.62 | 0.25 | ||||
| F | 25, 21 | SD90 | F | ↓ | 6.74 | 0.18 | 6.98 | 0.18 | |
| SD108 | M | ↓ | 6.57 | 0.07 | 6.99 | 0.08 | |||
| F | ↓ | 6.54 | 0.08 | 7.05 | 0.21 | ||||
| G | 27 | SD57 | F | ↓ | 6.45 | 0.11 | 6.99 | 0.17 | |
| Fibrinogenm | F | 25, 21 | SD90 | M | ↑ | 725.7 | 84.62 | 335.1 | 70.08 |
| F | ↑ | 653.2 | 81.96 | 273 | 65.69 | ||||
| SD108 | M | ↑ | 665.8 | 78.7 | 347.8 | 28.53 | |||
| F | ↑ | 559.6 | 77.32 | 262.5 | 40.9 | ||||
| G | 27 | SD4 | M | ↑ | 472 | 77.46 | 361.6 | 29.47 | |
| F | ↑ | 359.1 | 47.83 | 294.1 | 48.54 | ||||
| SD30 | M | ↑ | 407.3 | 95.76 | 307.5 | 49.2 | |||
| F | ↑ | 353.8 | 144.62 | 247 | 21.58 | ||||
| SD45 | M | ↑ | 620.8 | 41.91 | 339.8 | 50.42 | |||
| F | ↑ | 569.6 | 91.1 | 269.8 | 17.92 | ||||
| SD57 | F | ↑ | 297.8 | 42.58 | 238 | 14.92 | |||
Gender-matched concurrent controls
S.D. = standard deviation.
Cholesterol male reference range 50–131, female reference range. 51–137.
Triglycerides male reference range 35–274, female reference range 34–150.
Globulin male reference range 1.2–2.6, female reference range 1.5–2.6.
A/G ratio male reference range 1.4–2.9, female reference range 1.4–2.6.
Hemoglobin male reference range 11.3–15, female reference range 11.1–14.5.
Hematocrit male reference range 33.4–45.5, female reference range 33.3–43.8.
Platelets male reference range 237–725, female reference range 258–712.
MPV male reference range 5.5–7.6, female reference range 5.5–7.9.
APTT male reference range 51.56–113, female reference range 50.2–112.
PT male reference range 6–8.67, female reference range 6–8.63.
This parameter (fibrinogen) was only measured in Studies F (Marburg) & G (Ad35), so the absence of values from Studies D (Ad5 HIV) & E (Ebola) in this table should not be construed as there being no differences, but rather no measurements; male reference range: 224–500, female reference range 198–447
Cells highlighted in light gray represent mean values that fall outside the historical reference range.