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Transcript of 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email...
![Page 1: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/1.jpg)
1
The Life Raft Group
The Life Raft Group
40 Galesi Drive
Wayne, NJ 07470
Phone 973-837-9092
Fax 973-837-9095
Email [email protected]
www.liferaftgroup.org
![Page 2: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/2.jpg)
2
Life Raft Group Relapse Study
Disease Progression in Patients with Metastatic GIST Receiving Gleevec (Imatinib): The Effect of Drug Dosage
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3
Study Criteria
Metastatic GIST patientsInitial response to Gleevec
was shrinkageOn Gleevec one year or more
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4
Objectives Of Our Study
To determine whether there was a correlation between Gleevec dosage and the development of resistance, after one year, amongst metastatic GIST Patients who had initially experienced shrinkage on Gleevec.
To evaluate the difference between using starting dosage (intent to treat) and actual dosage (dosage delivered).
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5
Data Notes
Based upon patient reporting Adjusted for patient compliance-7 non-
compliant patients in study May be biased by non random distribution May not be representative of all patients Some subjectivity in assessment of initial
shrinkage and time of relapse Were not able to distinguish between 600
mg and 800 mg dosage levels due to small numbers
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6
Data Notes-2
Two patients who said that they had initial shrinkage (one of our study criteria) were excluded from study because the shrinkage was too marginal.
One patient, a clinical trial participant, was excluded from study because he was incorrectly categorized as metastatic GIST (another of our study criteria) when he actually had a cyst.
One patient, a clinical trial participant, has pediatric GIST.
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7
n = 169
92 males 77 females
78 Relapsed 91 Stable
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8
Starting Dose Distribution
Starting dose distributions were close to equal for males and females, with 43% of males and 36% of females on 600 mg or more.
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9
Starting Dose Distributions
≥ 600 < 600
Males 43% 57%
Females 36% 64%
Totals 40% 60%
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10
Starting Dose Relapse Rates
Although there was a higher relapse rate for the lower dose group (49.5% versus 41.2%) this was not statistically significant (p = 0.265).
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11
Relapse Rates Starting Dosage
n= 169 No. Rate
Total 78 46.2%
< 600 50 49.5%
≥ 600 28 41.2%
Males 44 47.8%
< 600 27 51.9%
≥ 600 17 42.5%
Females 34 44.2%
< 600 23 46.9%
≥ 600 11 39.3%
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12
Total Relapse Rates @ Starting Dosage
< 600
≥ 600
Total
Relapsed
Non-Relapsed
50.5%58.8%
53.8%
49.5%
41.2%46.2%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
Relapsed Non-Relapsed
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13
Male Relapse Rates @ Starting Dosage
< 600≥ 600
Total
Relapsed
Non-Relapsed
48.1%57.5%
52.2%51.9%
42.5%
47.8%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
Relapsed Non-Relapsed
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14
Female Relapse Rates @ Starting Dosage
< 600
≥ 600
Total
Relapsed
Non-Relapsed
53.1%
60.7%
55.8%
46.9%
39.3%44.2%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
Relapsed Non-Relapsed
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15
Dosage Change
38% of the total group had at least one dosage change.
A higher percentage of females (16%) had a net reduction from high to low dose than males (7%) although this was not statistically significant.
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16
MaleFemale
Total
Up
Dow n
Total
37.0%39.0%
37.9%
27.2%
33.8%
30.2%
9.8%
5.2% 7.7%0
0.05
0.1
0.15
0.2
0.25
0.3
0.35
0.4
% D
osag
e C
han
ge
Up Dow n Total
Dosage Change
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17
Actual Dosage-Total
There was a significantly lower relapse rate overall for higher actual dose versus lower dose: p = .001
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18
Actual Dosage-Gender
There was a significantly lower relapse rate for females alone for higher actual dose versus lower dose: p = .004
There was a non-significant lower relapse rate for males alone for higher actual dose versus lower dose: p = .116
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19
Relapse Actual Dosage
n= 169 No. Rate
Total 78 46.2%
< 600 63 52.9%
≥ 600 15 30.0%
Males 44 47.8%
< 600 31 53.4%
≥ 600 13 38.2%
Females 34 44.2%
< 600 32 52.5%
≥ 600 2 12.5%
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20
Total Relapse Rates @ Actual Dosage
< 600≥ 600
Total
Relapsed
Non-Relapsed
47.1%
70.0%
53.8%
52.9%
30.0%
46.2%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
Relapsed Non-Relapsed
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21
Male Relapse Rates @ Actual Dosage
< 600≥ 600
Total
Relapsed
Non-Relapsed
46.6% 61.8%
52.2%53.4%
38.2%
47.8%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
Relapsed Non-Relapsed
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22
Female Relapse Rate
While not statistically significant (due to small numbers), the actual dosage data does suggest a gender difference that needs to be watched in future studies.
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23
Female Relapse Rates @ Actual Dosage
< 600≥ 600
Total
Relapsed
Non-Relapsed
47.5%
87.5%
55.8%
52.5%
12.5%
44.2%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
Relapsed Non-Relapsed
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24
Actual vs. Starting Dosage
Lower dose group had an 8% higher relapse rate based upon starting dose
but a 23% higher relapse rate based upon actual dose.
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25
Relapse Starting Dosage Actual Dosage
n= 169 No. Rate No. Rate
Total 78 46.2% 78 46.2%
< 600 50 49.5% 63 52.9%
≥ 600 28 41.2% 15 30.0%
Males 44 47.8% 44 47.8%
< 600 27 51.9% 31 53.4%
≥ 600 17 42.5% 13 38.2%
Females 34 44.2% 34 44.2%
< 600 23 46.9% 32 52.5%
≥ 600 11 39.3% 2 12.5%
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26
Actual vs. Starting Dose Relapse Rates-Totals
Actual
Start
Total ≥ 600
Total < 600
52.9%
49.5%
30.0%
41.2%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%%
Re
lap
se
d
Total ≥ 600 Total < 600
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27
Actual vs. Starting Dosage Relapse Rates-Males
Actual
Start
Male ≥ 600
Male < 600
53.4%
51.9%
38.2%42.5%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%%
Rel
apse
d
Male ≥ 600 Male < 600
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28
Actual vs. Starting Dose Relapse Rates-Females
Actual
Start
Female ≥ 600
Female < 600
52.5%
46.9%
12.5%
39.3%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
% R
ela
ps
ed
Female ≥ 600 Female < 600
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29
Six Month Time PeriodActual Dosage
Relapse rates were relatively consistent in five six month time periods starting with month 13, although the fifth period (37 – 42 months) numbers are still too small.
This brings us 42 months out from day one.
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30
Relapse Over 6 Month Time Periods
n = 169 No. Relapsed/
No. Eligible
% Relapsed
13-18 months 25/169 14.8%
19-24 months 21/131 16.0%
25-30 months 15/93 16.1%
31-36 months 12/67 17.9%
37-42 months 5/34 14.7%
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31
Relapse Rates Over 6 Month Time Periods
0.0%
2.0%
4.0%
6.0%
8.0%
10.0%
12.0%
14.0%
16.0%
18.0%
20.0%
13--18 19--24 25--30 31--36 37--42
Time Periods
Rela
pse R
ate
s
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32
Relapse Over 6 Month Time Periods By Dosage
< 600 ≥ 600
13-18 months 22/119=18.5% 3/50 = 6.0%
19-24 months 17/88 = 19.3% 4/43 = 9.3%
25-30 months 11/61 = 18.0% 4/32 = 12.5%
31-36 months 9/44 = 20.5% 3/23 = 13.0%
37-42 months 4/23 = 17.4% 1/11 = 9.1%
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33
Relapse Rates Over 6 Month Time Periods By Dosage
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
13--18 19--24 25--30 31--36 37--42
Time Periods
Rel
apse
Rat
e
Higher Dosage
≥ 600
Low er Dosage
< 600
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34
Using the more traditional Kaplan-Meier analysis method
which takes into account length of treatment time
Relapse rates overall and separately by gender were significantly lower for higher dose
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35
Relapse Curves: Effect of Dose Level
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
12 18 24 30 36 42 48 54
Ending Month
Perc
ent
Not
Rela
psed S
ince M
onth
12
Dose ≥ 600
Dose < 600
P=0.0037 one-tail (statistically significant)
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36
Relapse Curves Dose Level for Males
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
12 18 24 30 36 42 48 54
Ending Month
Perc
ent
Not
Rela
psed S
ince M
onth
12
Dose ≥ 600
Dose < 600
P=0.00418 one-tail (statistically significant)
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37
Relapse Curves Dose Level for Females
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
12 18 24 30 36 42 48 54
Ending Month
Perc
ent
Not
Rela
psed S
ince M
onth
12
Dose ≥ 600
Dose < 600
P=0.0089 one-tail (statistically significant)
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38
Conclusions
When looking at actual dosage, patients on 600 mg or more of Gleevec are significantly more likely to have lower relapse rates than do patients on less than 600 mg.
Actual dosage produces substantially different results than starting dosage.
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39
Our Relapse Study Team
Norman Scherzer, LRG Exec. DirectorJerry Call, Science CoordinatorPamela Barckett, Medical Rsch Asst.David Josephy, PhD, BiochemistMichael Josephy, MSc, MathematicianRichard Singleton, PhD, Statistician
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40
Hold These Slides
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41
7 Non Compliant Patients In Study
NC 1 Prescribed 600: took about 300-relapsed
NC 4 Prescribed 800: took about 400-relapsed
NC 5 Dr. raised dose from 400 to 600 after relapse; takes 400
NC 10 Prescribed 400: takes betw. 200 & 300-o.k.
NC 11 Prescribed 800: took betw. 400 & 600-relapsed
NC 12 Prescribed 600: took betw. 400 & 500-relapsed
NC 14 Prescribed 600: takes betw. 400 & 500-o.k.
![Page 42: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/42.jpg)
42
Relapse No Relapse Totals
Total 78 46.2% 91 53.8% 169 100%
< 600 Start< 600 Actual
50 63
49.5%52.9%
51 56
50.5%47.1%
101 119
100%100%
≥ 600 Start≥ 600 Actual
28 15
41.2%30.0%
40 35
58.8%70.0%
68 50
100%100%
Males 44 47.8% 48 52.2% 92 100%
< 600 Start< 600 Actual
27 31
51.9%53.4%
25 27
48.1%46.6%
52 58
100%100%
≥ 600 Start≥ 600 Actual
1713
42.5%38.2%
2321
57.5%61.8%
4034
100%100%
Females 34 44.2% 43 55.8% 77 100%
< 600 Start< 600 Actual
2332
46.9%52.5%
2629
53.1%47.5%
4961
100%100%
≥ 600 Start≥ 600 Actual
11 2
39.3%12.5%
1714
60.7%87.5%
2816
100%100%
![Page 43: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/43.jpg)
44
Actual Dosage
Relapse No Relapse Totals
Data needs to be revised
Total 71 43.9% 91 56.1% 162 100%
≤ 400 60 51.3% 57 48.7% 117 100%
≥ 600 11 24.4% 34 *
75.6% 45 100%
Males 42 46.2% 49 53.8% 91 100%
≤ 400 32 50.8% 31 49.2% 63 100%
≥ 600 10 35.7% 18 *
64.3% 28 100%
Females
29 40.8% 42 59.2% 71 100%
≤ 400 28 52.0% 26 48.0% 54 100%
≥ 600 1 5.9% 16 94.1% 17 100%
* Includes 1 patient at 500 mg
![Page 44: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/44.jpg)
45
Relapse No Relapse Totals
Starting vs. Actual Data needs to be revised
Total 71 43.9% 91 56.1% 162 Δ
100%
≤ 400 48 60
48.5%51.3%
51 57
51.5%48.7%
99 117 + 18
100%100%
≥ 600 23 11
36.5%24.4%
40 34
63.5%75.6%
63 45 - 18
100%100%
Males 42 46.2% 49 53.8% 91 100%
≤ 400 27 32
49.1%50.8%
28 31
50.9%49.2%
55 63 + 8
100%100%
≥ 600 15 10
41.7%35.7%
21 18
58.3%64.3%
36 28 - 8
100%100%
Females 29 40.8% 42 59.2% 71 100%
≤ 400 21 28
47.7%52.0%
23 26
52.3%48.0%
44 54 + 10
100%100%
≥ 600 8 1
29.6% 5.9%
19 16
70.4%94.1%
27 17 -10
100%100%
![Page 45: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/45.jpg)
46
Singleton Slides
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47
Relapse Curves (Effect of I nteraction)
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
12 18 24 30 36 42 48 54
Ending Month
Perc
ent
Not
Rela
psed S
ince
Month
12
F≥600 & M<600
F<600 & M≥600
P=0.927 two-tail (not statistically significant)
![Page 47: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/47.jpg)
48
Relapse Curves (Gender for Dose ≥ 600 mg/ day)
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
12 18 24 30 36 42 48 54
Ending Month
Perc
ent
Not
Rela
psed S
ince
Month
12
Female
Male
P=0.1464 (not statistically significant)
![Page 48: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/48.jpg)
49
Relapse Curves (Gender for Dose < 600 mg/ day)
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
12 18 24 30 36 42 48 54
Ending Month
Perc
ent
Not
Rela
pse
d S
ince
Month
12)
Female
Male
P=0.7574 two-tail (not statistically significant)
![Page 49: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/49.jpg)
50
Relapse Curves (Gender for Dose < 600 mg/ day)
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
12 18 24 30 36 42 48 54
Ending Month
Perc
ent
Not
Rela
pse
d S
ince
Month
12)
Female
Male
![Page 50: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/50.jpg)
51
Kaplan-Meier Relapse Curves (Dose)
0%
20%
40%
60%
80%
100%
120%
12 18 24 30 36 42 48
Ending Month
Perc
en
t N
ot
Rela
psed S
ince M
on
th 1
2
Dose >500
Dose ≤500
All Doses
P = 0.0037 one-tail) statistically significant)
![Page 51: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/51.jpg)
52
Kaplan-Meier Relapse Curves (Dose)
0%
20%
40%
60%
80%
100%
120%
12 18 24 30 36 42 48
Ending Month
Perc
en
t N
ot
Rela
psed
Sin
ce M
on
th 1
2
Dose ≥600
Dose ≤500
All Doses
P = 0.0037 (one-tail) statistically significant
![Page 52: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/52.jpg)
53
Kaplan-Meier Relapse Curves (Gender)
0%
20%
40%
60%
80%
100%
120%
12 18 24 30 36 42 48
Ending Month
Perc
ent
Not
Rela
psed S
ince
Month
12
Female
Male
Total
P = 0.7334 two-tail (not statistically significant)
![Page 53: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/53.jpg)
54
Kaplan-Meier Relapse Curves (Dose/ Gender I nteraction)
0%
20%
40%
60%
80%
100%
120%
12 18 24 30 36 42 48
Ending Month
Perc
ent
Not
Rela
psed S
ince
Month
12
F>500 & M≤500
F≤500 & M>500
Total
P = 0.927 two-tail (not statistically significant)
![Page 54: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/54.jpg)
55
Kaplan-Meier Relapse Curves (Gender)
0%
20%
40%
60%
80%
100%
120%
12 18 24 30 36 42 48
Ending Month
Perc
ent
Not
Rela
pse
d S
ince
Month
12
Female
Male
Total
![Page 55: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/55.jpg)
56
Kaplan-Meier Relapse Curves (Dose/ Gender I nteraction)
0%
20%
40%
60%
80%
100%
120%
12 18 24 30 36 42 48
Ending Month
Perc
ent
Not
Rela
psed S
ince
Month
12
F>500 & M≤500
F≤500 & M>500
Total
P = 0.927 two-tail (not statistically significant)
![Page 56: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/56.jpg)
57
Relapse Starting Dosage
n= 169 No. Rate
Total 78 46.2%
≥ 600 28 41.2%
Males 44 47.8%
≥ 600 17 42.5%
Females 34 44.2%
≥ 600 11 39.3%
![Page 57: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/57.jpg)
58
Relapse Actual Dosage
n= 169 No. Rate
Total 78 46.2%
≥ 600 15 30.0%
Males 44 47.8%
≥ 600 13 38.2%
Females 34 44.2%
≥ 600 2 12.5%
![Page 58: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/58.jpg)
59
Relapse Starting Dosage Actual Dosage
n= 169 No. Rate No. Rate
Total 78 46.2% 78 46.2%
≥ 600 28 41.2% 15 30.0%
Males 44 47.8% 44 47.8%
≥ 600 17 42.5% 13 38.2%
Females 34 44.2% 34 44.2%
≥ 600 11 39.3% 2 12.5%
![Page 59: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/59.jpg)
60
Relapse Starting Dosage Actual Dosage
n= 169 No. Rate No. Rate
Total 78 46.2% 78 46.2%
< 600 50 49.5% 63 52.9%
≥ 600 28 41.2% 15 30.0%
Males 44 47.8% 44 47.8%
< 600 27 51.9% 31 53.4%
≥ 600 17 42.5% 13 38.2%
Females 34 44.2% 34 44.2%
< 600 23 46.9% 32 52.5%
≥ 600 11 39.3% 2 12.5%
![Page 60: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/60.jpg)
61
% On 600 mg or More
T otal
Male
Female
Actual
Star ting
40%43%
36%
30%
37%
21%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
Actual Star ting
![Page 61: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/61.jpg)
62
Dosage Change
Down Up None
Male 25 9 58
Female 26 4 47
Total 51 13 105
![Page 62: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/62.jpg)
63
Dosage Change
Dose < 600 ≥ 600 Totals % ≥ 600 Change
Start 101 68 169 40% N.A.
Male 52 40 92 43% N.A.
Female 49 28 77 36% N.A.
Actual 119 50 169 30% - 10%
Male 58 34 92 37% -6%
Female 61 16 77 21% -15%
![Page 63: 1 The Life Raft Group 40 Galesi Drive Wayne, NJ 07470 Phone 973-837-9092 Fax 973-837-9095 Email liferaft@liferaftgroup.orgliferaft@liferaftgroup.org .](https://reader036.fdocuments.us/reader036/viewer/2022062721/56649f215503460f94c39b75/html5/thumbnails/63.jpg)
64
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65
Relapse Curves Effect of Gender
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
12 18 24 30 36 42 48 54
Ending Month
Perc
ent
Not
Rela
psed S
ince M
onth
12
Female
Male
P=0.7334 two-tail (not statistically significant)