To view the following table, try copying this info and pasting into notepad and adjusting the font. Hopefully (if there aren't any hard returns put in the table) you can view the table correctly.
Clearly not all placebo patients would count as an event (ie did NOT excerbate). If all placebo patients exacerbated, then there would have been no need to add 20 patients because the target would have been met. In the trial note that even though 20 patients were added the unblinding occured with "approximately one-half the number of patients ORIGINALLY targeted for enrollment."
So what would you get assuming different total trial patient population of (50,60,70,80,90,100) each with a target event of 1/2 the original target enrollment (25,30,35,40,45,50), assuming different Hazard Ratios (0,.05,.15,.20,.25,.30,.35,.40,.45,.50,.55,.60,.65,.70,.75,.80,.85,.90,.95, 1.00) and percentage Placebo Events (excacerbations) from 1% all the way through to
100% in 1% increments?
The one input i used was Target Events (ie 1/2 the patient population). This is the same number as the placebo patients and the same number as the gevo treated patients.
First Column= % placebo events from 1 to 100 by 1's
Second Column=Number of Placebos who excacerbated based on percentages listed in First Column
Third Column=at the top of the next 19 columns are the different hazard ratios and each calculated number in the column are the gevo events, these are calculated from the formula:
Hazard Ratio = gevokizumab events(exacerbations) divided by placebo events(exacerbations)
therefore,
gevokizumab events=Number Placebo events (from second column) multiplied by Hazard Rate at top of column
Note: if Placebo Events plus Gevo Events > Target events, then put a blank in the column entry.
For example here are the results for Target Events=30 (total patients=60) and assuming 1/3 of the placebo patients do NOT exacerbate (ie Placebo events=67%), the row would look like:
67,20.10,1.01,3.02,4.02,5.03,6.03,7.04,8.04,9.05 and the rest of the columns would be blank.
Now, assuming a 0.3 hazard ratio, the total exacerbations would be 20.10+6.03=26.13 or 26 patients, but you need 30 before you can unblind the data.
Anyway, draw your own conclusions.
Target Events = 30 data table below:
0.05 0.15 0.20 0.25 0.30 0.35 0.40 0.45 0.50 0.55 0.60 0.65 0.70 0.75 0.80 0.85 0.90 0.95 1.00
P-Events G-Events G-Events G-Events G-Events G-Events G-Events G-Events G-Events G-Events G-Events G-Events G-Events G-Events G-Events G-Events G-Events G-Events G-Events G-Events
1 0.30 0.02 0.05 0.06 0.08 0.09 0.11 0.12 0.14 0.15 0.17 0.18 0.20 0.21 0.23 0.24 0.26 0.27 0.29 0.30
2 0.60 0.03 0.09 0.12 0.15 0.18 0.21 0.24 0.27 0.30 0.33 0.36 0.39 0.42 0.45 0.48 0.51 0.54 0.57 0.60
3 0.90 0.05 0.14 0.18 0.23 0.27 0.32 0.36 0.41 0.45 0.50 0.54 0.59 0.63 0.68 0.72 0.77 0.81 0.86 0.90
4 1.20 0.06 0.18 0.24 0.30 0.36 0.42 0.48 0.54 0.60 0.66 0.72 0.78 0.84 0.90 0.96 1.02 1.08 1.14 1.20
5 1.50 0.08 0.23 0.30 0.38 0.45 0.53 0.60 0.68 0.75 0.83 0.90 0.98 1.05 1.13 1.20 1.28 1.35 1.43 1.50
6 1.80 0.09 0.27 0.36 0.45 0.54 0.63 0.72 0.81 0.90 0.99 1.08 1.17 1.26 1.35 1.44 1.53 1.62 1.71 1.80
7 2.10 0.11 0.32 0.42 0.53 0.63 0.74 0.84 0.95 1.05 1.16 1.26 1.37 1.47 1.58 1.68 1.79 1.89 2.00 2.10
8 2.40 0.12 0.36 0.48 0.60 0.72 0.84 0.96 1.08 1.20 1.32 1.44 1.56 1.68 1.80 1.92 2.04 2.16 2.28 2.40
9 2.70 0.14 0.41 0.54 0.68 0.81 0.95 1.08 1.22 1.35 1.49 1.62 1.76 1.89 2.03 2.16 2.30 2.43 2.57 2.70
10 3.00 0.15 0.45 0.60 0.75 0.90 1.05 1.20 1.35 1.50 1.65 1.80 1.95 2.10 2.25 2.40 2.55 2.70 2.85 3.00
11 3.30 0.17 0.50 0.66 0.83 0.99 1.16 1.32 1.49 1.65 1.82 1.98 2.15 2.31 2.48 2.64 2.81 2.97 3.14 3.30
12 3.60 0.18 0.54 0.72 0.90 1.08 1.26 1.44 1.62 1.80 1.98 2.16 2.34 2.52 2.70 2.88 3.06 3.24 3.42 3.60
13 3.90 0.20 0.59 0.78 0.98 1.17 1.37 1.56 1.76 1.95 2.15 2.34 2.54 2.73 2.93 3.12 3.32 3.51 3.71 3.90
14 4.20 0.21 0.63 0.84 1.05 1.26 1.47 1.68 1.89 2.10 2.31 2.52 2.73 2.94 3.15 3.36 3.57 3.78 3.99 4.20
15 4.50 0.23 0.68 0.90 1.13 1.35 1.58 1.80 2.03 2.25 2.48 2.70 2.93 3.15 3.38 3.60 3.83 4.05 4.28 4.50
16 4.80 0.24 0.72 0.96 1.20 1.44 1.68 1.92 2.16 2.40 2.64 2.88 3.12 3.36 3.60 3.84 4.08 4.32 4.56 4.80
17 5.10 0.26 0.77 1.02 1.28 1.53 1.79 2.04 2.30 2.55 2.81 3.06 3.32 3.57 3.83 4.08 4.34 4.59 4.85 5.10
18 5.40 0.27 0.81 1.08 1.35 1.62 1.89 2.16 2.43 2.70 2.97 3.24 3.51 3.78 4.05 4.32 4.59 4.86 5.13 5.40
19 5.70 0.29 0.86 1.14 1.43 1.71 2.00 2.28 2.57 2.85 3.14 3.42 3.71 3.99 4.28 4.56 4.85 5.13 5.42 5.70
20 6.00 0.30 0.90 1.20 1.50 1.80 2.10 2.40 2.70 3.00 3.30 3.60 3.90 4.20 4.50 4.80 5.10 5.40 5.70 6.00
21 6.30 0.32 0.95 1.26 1.58 1.89 2.21 2.52 2.84 3.15 3.47 3.78 4.10 4.41 4.73 5.04 5.36 5.67 5.99 6.30
22 6.60 0.33 0.99 1.32 1.65 1.98 2.31 2.64 2.97 3.30 3.63 3.96 4.29 4.62 4.95 5.28 5.61 5.94 6.27 6.60
23 6.90 0.35 1.04 1.38 1.73 2.07 2.42 2.76 3.11 3.45 3.80 4.14 4.49 4.83 5.18 5.52 5.87 6.21 6.56 6.90
24 7.20 0.36 1.08 1.44 1.80 2.16 2.52 2.88 3.24 3.60 3.96 4.32 4.68 5.04 5.40 5.76 6.12 6.48 6.84 7.20
25 7.50 0.38 1.13 1.50 1.88 2.25 2.63 3.00 3.38 3.75 4.13 4.50 4.88 5.25 5.63 6.00 6.38 6.75 7.13 7.50
26 7.80 0.39 1.17 1.56 1.95 2.34 2.73 3.12 3.51 3.90 4.29 4.68 5.07 5.46 5.85 6.24 6.63 7.02 7.41 7.80
27 8.10 0.41 1.22 1.62 2.03 2.43 2.84 3.24 3.65 4.05 4.46 4.86 5.27 5.67 6.08 6.48 6.89 7.29 7.70 8.10
28 8.40 0.42 1.26 1.68 2.10 2.52 2.94 3.36 3.78 4.20 4.62 5.04 5.46 5.88 6.30 6.72 7.14 7.56 7.98 8.40
29 8.70 0.44 1.31 1.74 2.18 2.61 3.05 3.48 3.92 4.35 4.79 5.22 5.66 6.09 6.53 6.96 7.40 7.83 8.27 8.70
30 9.00 0.45 1.35 1.80 2.25 2.70 3.15 3.60 4.05 4.50 4.95 5.40 5.85 6.30 6.75 7.20 7.65 8.10 8.55 9.00
31 9.30 0.47 1.40 1.86 2.33 2.79 3.26 3.72 4.19 4.65 5.12 5.58 6.05 6.51 6.98 7.44 7.91 8.37 8.84 9.30
32 9.60 0.48 1.44 1.92 2.40 2.88 3.36 3.84 4.32 4.80 5.28 5.76 6.24 6.72 7.20 7.68 8.16 8.64 9.12 9.60
33 9.90 0.50 1.49 1.98 2.48 2.97 3.47 3.96 4.46 4.95 5.45 5.94 6.44 6.93 7.43 7.92 8.42 8.91 9.41 9.90
34 10.20 0.51 1.53 2.04 2.55 3.06 3.57 4.08 4.59 5.10 5.61 6.12 6.63 7.14 7.65 8.16 8.67 9.18 9.69 10.20
35 10.50 0.53 1.58 2.10 2.63 3.15 3.68 4.20 4.73 5.25 5.78 6.30 6.83 7.35 7.88 8.40 8.93 9.45 9.98 10.50
36 10.80 0.54 1.62 2.16 2.70 3.24 3.78 4.32 4.86 5.40 5.94 6.48 7.02 7.56 8.10 8.64 9.18 9.72 10.26 10.80
37 11.10 0.56 1.67 2.22 2.78 3.33 3.89 4.44 5.00 5.55 6.11 6.66 7.22 7.77 8.33 8.88 9.44 9.99 10.55 11.10
38 11.40 0.57 1.71 2.28 2.85 3.42 3.99 4.56 5.13 5.70 6.27 6.84 7.41 7.98 8.55 9.12 9.69 10.26 10.83 11.40
39 11.70 0.59 1.76 2.34 2.93 3.51 4.10 4.68 5.27 5.85 6.44 7.02 7.61 8.19 8.78 9.36 9.95 10.53 11.12 11.70
40 12.00 0.60 1.80 2.40 3.00 3.60 4.20 4.80 5.40 6.00 6.60 7.20 7.80 8.40 9.00 9.60 10.20 10.80 11.40 12.00
41 12.30 0.62 1.85 2.46 3.08 3.69 4.31 4.92 5.54 6.15 6.77 7.38 8.00 8.61 9.23 9.84 10.46 11.07 11.69 12.30
42 12.60 0.63 1.89 2.52 3.15 3.78 4.41 5.04 5.67 6.30 6.93 7.56 8.19 8.82 9.45 10.08 10.71 11.34 11.97 12.60
43 12.90 0.65 1.94 2.58 3.23 3.87 4.52 5.16 5.81 6.45 7.10 7.74 8.39 9.03 9.68 10.32 10.97 11.61 12.26 12.90
44 13.20 0.66 1.98 2.64 3.30 3.96 4.62 5.28 5.94 6.60 7.26 7.92 8.58 9.24 9.90 10.56 11.22 11.88 12.54 13.20
45 13.50 0.68 2.03 2.70 3.38 4.05 4.73 5.40 6.08 6.75 7.43 8.10 8.78 9.45 10.13 10.80 11.48 12.15 12.83 13.50
46 13.80 0.69 2.07 2.76 3.45 4.14 4.83 5.52 6.21 6.90 7.59 8.28 8.97 9.66 10.35 11.04 11.73 12.42 13.11 13.80
47 14.10 0.71 2.12 2.82 3.53 4.23 4.94 5.64 6.35 7.05 7.76 8.46 9.17 9.87 10.58 11.28 11.99 12.69 13.40 14.10
48 14.40 0.72 2.16 2.88 3.60 4.32 5.04 5.76 6.48 7.20 7.92 8.64 9.36 10.08 10.80 11.52 12.24 12.96 13.68 14.40
49 14.70 0.74 2.21 2.94 3.68 4.41 5.15 5.88 6.62 7.35 8.09 8.82 9.56 10.29 11.03 11.76 12.50 13.23 13.97 14.70
50 15.00 0.75 2.25 3.00 3.75 4.50 5.25 6.00 6.75 7.50 8.25 9.00 9.75 10.50 11.25 12.00 12.75 13.50 14.25
51 15.30 0.77 2.30 3.06 3.83 4.59 5.36 6.12 6.89 7.65 8.42 9.18 9.95 10.71 11.48 12.24 13.01 13.77 14.54
52 15.60 0.78 2.34 3.12 3.90 4.68 5.46 6.24 7.02 7.80 8.58 9.36 10.14 10.92 11.70 12.48 13.26 14.04
53 15.90 0.80 2.39 3.18 3.98 4.77 5.57 6.36 7.16 7.95 8.75 9.54 10.34 11.13 11.93 12.72 13.52
54 16.20 0.81 2.43 3.24 4.05 4.86 5.67 6.48 7.29 8.10 8.91 9.72 10.53 11.34 12.15 12.96 13.77
55 16.50 0.83 2.48 3.30 4.13 4.95 5.78 6.60 7.43 8.25 9.08 9.90 10.73 11.55 12.38 13.20
56 16.80 0.84 2.52 3.36 4.20 5.04 5.88 6.72 7.56 8.40 9.24 10.08 10.92 11.76 12.60
57 17.10 0.86 2.57 3.42 4.28 5.13 5.99 6.84 7.70 8.55 9.41 10.26 11.12 11.97 12.83
58 17.40 0.87 2.61 3.48 4.35 5.22 6.09 6.96 7.83 8.70 9.57 10.44 11.31 12.18
59 17.70 0.89 2.66 3.54 4.43 5.31 6.20 7.08 7.97 8.85 9.74 10.62 11.51
60 18.00 0.90 2.70 3.60 4.50 5.40 6.30 7.20 8.10 9.00 9.90 10.80 11.70
61 18.30 0.92 2.75 3.66 4.58 5.49 6.41 7.32 8.24 9.15 10.07 10.98
62 18.60 0.93 2.79 3.72 4.65 5.58 6.51 7.44 8.37 9.30 10.23 11.16
63 18.90 0.95 2.84 3.78 4.73 5.67 6.62 7.56 8.51 9.45 10.40
64 19.20 0.96 2.88 3.84 4.80 5.76 6.72 7.68 8.64 9.60 10.56
65 19.50 0.98 2.93 3.90 4.88 5.85 6.83 7.80 8.78 9.75
66 19.80 0.99 2.97 3.96 4.95 5.94 6.93 7.92 8.91 9.90
67 20.10 1.01 3.02 4.02 5.03 6.03 7.04 8.04 9.05
68 20.40 1.02 3.06 4.08 5.10 6.12 7.14 8.16 9.18
69 20.70 1.04 3.11 4.14 5.18 6.21 7.25 8.28
70 21.00 1.05 3.15 4.20 5.25 6.30 7.35 8.40
71 21.30 1.07 3.20 4.26 5.33 6.39 7.46 8.52
72 21.60 1.08 3.24 4.32 5.40 6.48 7.56
73 21.90 1.10 3.29 4.38 5.48 6.57 7.67
74 22.20 1.11 3.33 4.44 5.55 6.66 7.77
75 22.50 1.13 3.38 4.50 5.63 6.75
76 22.80 1.14 3.42 4.56 5.70 6.84
77 23.10 1.16 3.47 4.62 5.78
78 23.40 1.17 3.51 4.68 5.85
79 23.70 1.19 3.56 4.74 5.93
80 24.00 1.20 3.60 4.80
81 24.30 1.22 3.65 4.86
82 24.60 1.23 3.69 4.92
83 24.90 1.25 3.74 4.98
84 25.20 1.26 3.78
85 25.50 1.28 3.83
86 25.80 1.29 3.87
87 26.10 1.31
88 26.40 1.32
89 26.70 1.34
90 27.00 1.35
91 27.30 1.37
92 27.60 1.38
93 27.90 1.40
94 28.20 1.41
95 28.50 1.43
96 28.80
97 29.10
98 29.40
99 29.70
100 30.00
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