Full Study Report-97-171

Comparative Pharmacokinetic Study of Hamsyl® Injection 5 ml/vial
Clinical Report (Protocol No.: EM002)
14.0 TABLES, FIGURES AND GRAPHS REFERRED TO BUT NOT INCLUDED

IN THE TEXT
14.1 Demographic Data
14.1.1 Summary of Demographic Data of Patients
Table 11: Demographic Data
Patient Number Age (years) Height (cms) Weight (kgs) Gender

1 6 105 17 Female
2 7 122 21 Male
3 7 109 14 Female
4 11 150 40.8 Male
5 9 123 21 Male
6 8 137 49.5 Female
7 13 147 31.5 Male
8 14 159 55.7 Female
9 10 142 28 Female
10 13 161 42 Male
11 10 133 28.3 Female
12 8 134 30 Male
13 12 162 42 Female
14 9 126 22 Male
15 13 159 41 Male
16 7 122 27.5 Male
17 7 103 21.5 Male
18 8 129 30 Male
19 8 133 24.5 Female
20 15 166 46.5 Female
21 9 137 27 Male
22 12 148 60 Male
23 10 140 30.8 Female
24 7 117 10 Male
25 10 133 27.6 Male
26 12 136 27.5 Male
27 6 114 16.9 Male
28 14 155 43 Male
29 6 122 21 Male
Minimum 6 103 10
Maximum 15 166 60
Mean 9.7 135.3 31.0
Standard Deviation 2.7 17.6 12.4
Median 9 134 28.0
N 29 29 29
Confidential Page 97 of 174

Gennova Biopharmaceuticals Ltd.,
14.1.2 BSA details for Patient participated in the study

Table 12: BSA details for Patient participated in the study
SUB ID Age (year) Height (cm) Weight (kg) BMI (kg/m2) BSA
01-001 6 105 17 15.72 0.70
01-002 7 122 21 14.11 0.84
01-003 7 109 14 12.00 0.65
01-004 11 150 40.8 18.10 1.29
01-005 9 123 21 13.70 0.85
01-006 8 137 49.5 26.37 1.37
01-007 13 147 31.5 14.58 1.13
01-008 14 159 55.7 22.00 1.50
01-009 10 142 28 13.89 1.00
01-010 13 161 42 16.20 1.37
01-011 10 133 28.3 15.90 1.02
01-012 8 134 30 16.46 1.06
01-013 12 162 42 16.00 1.37
01-014 9 126 22 13.90 0.87
01-015 13 159 41 16.22 1.34
01-016 7 122 27.5 18.40 0.96
01-017 7 103 21.5 20.27 0.78
01-018 8 129 30 18.03 1.00
01-019 8 133 24.5 13.85 0.95
01-020 15 166 46.5 16.87 1.46
01-021 9 137 27 13.90 1.--
01-022 12 148 60 27.40 1.57
01-023 10 140 30.8 15.70 1.00
01-024 7 117 10 7.30 0.72
01-025 10 133 27.6 15.60 1.00
01-026 12 136 27.5 14.90 1.03
01-027 6 114 16.9 13.00 0.73
01-028 14 155 43 17.90 1.35
01-029 6 122 21 14.00 0.84

14.2 Endpoint Data

14.2.1 Patients Data for Primary and Secondary Outcome Evaluation
As per protocol blood samples of all the enrolled patients were taken at
specified time points. These samples were tested for L-asparaginase activity,
antibody titers and levels of amino acids
Table 13: Plasma L-asparaginase Activity for All Enrolled Patients
0.00 1.00 6.00 24.00 48.00 120.00 168.00 312.00
Patient No. Drug
hr hr hr hr hr hr hr hr
1 T 0.7671 20.466 151.96 236.44 397.09 337.34 290.54 126.83
2 R 0.000 31.351 186.59 300.19 438.49 384.34 269.52 127.40
3 T 0.000 20.466 182.13 322.64 391.16 269.52 172.08 96.180
4 R 0.000 18.793 153.75 185.95 235.03 171.45 116.07 73.084
5 R 0.000 31.350 150.16 NA 461.73 NA 277.140 144.50
6 T 11.977 19.955 51.329 308.715 642.393 439.446 293.277 NA
7 R 12.802 26.628 56.392 177.218 376.240 283.994 163.352 NA
8 T 7.337 11.379 44.761 91.124 268.15 156.65 126.19 90.51
9 R 8.804 13.013 46.527 93.599 166.76 170.21 125.45 91.124
10 T 9.503 33.651 121.10 179.89 440.91 308.72 200.58 167.95
11 T 2.699 13.000 177.80 272.21 576.23 351.53 297.90 149.69
12 R 10.479 21.525 256.000 314.190 579.235 428.775 204.386 NA
13 T 13.647 21.167 134.25 294.15 532.68 354.68 300.74 179.23
14 R 11.412 16.299 46.211 239.46 428.78 296.96 270.42 131.74
15 T 11.726 62.144 250.97 364.78 484.07 350.23 294.69 102.31
16 R 0.000 44.732 153.98 206.65 617.66 444.40 341.18 91.775
17 R 0.000 38.082 268.33 482.17 580.41 414.51 346.60 188.29
18 T 0.000 24.577 298.34 425.92 481.53 215.07 117.73 83.005

0.00 1.00 6.00 24.00 48.00 120.00 168.00 312.00

Patient No. Drug
hr hr hr hr hr hr hr hr
19 R 0.000 41.750 201.92 222.50 591.43 332.86 251.61 102.65
20 T 0.000 0.0000 35.235 201.92 374.78 325.59 239.17 118.39
21 R 0.000 8.2068 111.07 256.59 348.31 225.81 273.39 29.172
22 T 0.000 2.867 7.584 81.472 221.838 91.653 22.466 1.013
23 T 0.000 23.561 37.803 83.475 126.6 139.91 96.904 35.005
24 R 4.574 4.5747 167.72 NA 541.77 487.61 361.88 199.02
25 R 0.000 31.288 208.75 380.3 444.77 616.98 383.41 295.02
26 T 12.443 16.007 80.454 140.56 203.87 169.61 102.92 76.675
27 R 0.000 61.951 165.04 307.65 527.02 480.62 211.21 76.675
28 R 1.026 15.285 89.097 352.83 383.41 343.88 306.24 138.39
29 T 0.000 9.0097 183.54 386.53 517.92 346.85 161.63 75.736
Minimum 0.000 0.000 7.584 81.472 126.600 91.653 22.466 1.013
Maximum 13.647 62.144 298.340 482.170 642.393 616.980 383.410 295.020
Mean 4.110 23.554 138.579 255.893 426.906 319.257 228.230 115.052
Median 0.000 20.466 151.960 256.590 440.910 335.100 251.610 102.480
SD 5.303 15.412 78.577 107.743 141.037 122.381 92.678 60.455
CV% 129.030 65.433 56.702 42.105 33.037 38.333 40.607 52.545
N 29 29 29 27 29 28 29 26
NA= Not Available

Table 14: Plasma Anti-L-asparaginase Antibodies Estimation for All

Enrolled Patients
Time (day)
0.00 15.00 22.00
Patient No. Drug Antibodies (ng/mL)
1 T -0.756 -0.965 -1.011
2 R 5.6911 2.7968 -0.097403
3 T -0.060 -0.997 -1.016
4 R -0.9462 -1.09 0.20872
5 R 0.914 2.472 NA
6 T -0.042 NA NA
7 R -0.533 NA NA
8 T 6.039 7.110 7.087

9 R 9.0074 0.097403 5.0417
10 T 2.101 1.150 -0.042
11 T 2.295 0.305 0.212
12 R -0.673 NA NA
13 T -0.275 -0.896 -0.748

14 R 0.69944 -0.20501 -0.56215
15 T -0.864 -1.040 -1.086
16 R 1.4091 -0.34879 -0.55288
17 R 0.33302 -0.96104 -0.88683
18 T -0.803 -0.942 NA
19 R -0.2282 -0.57607 -0.16327
20 T -0.975 -0.789 3.543
21 R 10.107 -0.46575 1.1438
22 T 1.300 -0.471 -0.466
23 T 9.172 9.573 9.681
24 R -0.44618 0.10665 -0.29941
25 R 9.9207 12.871 7.2984
26 T 1.540 0.165 -0.392

27 R 8.9863 2.1468 0.61546

28 R 0.17025 -0.49022 -0.63209
29 T 4.079 -0.123 -0.104
Minimum -0.975 -1.090 -1.086
Maximum 10.107 12.871 9.681
Mean 2.316 1.094 1.116
Median 0.699 -0.277 -0.133
SD 3.773 3.495 3.045
CV% 162.916 319.587 272.930
N 29 26 24
NA= Not available

Table 15: Plasma L-asparagine Amino Acid Estimation for All Enrolled Patients
Time (day)
0.00 15.00 22.00
Patient Drug micro mol\ml
1 T 19.886 1.568 1.239
2 R 16.023 1.508 0.932
3 T 19.545 1.231 1.360
4 R 34.811 1.390 1.136
5 R 33.220 0.254 NA
6 T 4.962 NA NA
7 R 5.568 NA NA
8 T 43.939 2.008 3.011

9 R 26.364 1.417 1.341
10 T 30.795 1.644 1.337
11 T 29.015 0.727 0.693
12 R 47.348 NA NA
13 T 26.515 1.152 1.235

14 R 45.076 1.227 1.470
15 T 43.182 5.644 1.170
16 R 19.735 25.568 1.265
17 R 19.697 1.367 1.341
18 T 25.189 10.871 NA
19 R 22.311 1.269 1.197
20 T 58.7 38.6 0.8
21 R 29.3 1.6 1.5
22 T 33.8 2.4 NA
23 T 30.9 0.9 0.6
24 R 34.9 1.5 1.2
25 R 34.0 1.3 1.7
26 T 20.4 1.0 1.0
27 R 7.7 10.0 1.1

28 R 24.7 1.3 2.0

29 T 25.7 25.8 26.3
Minimum 4.962 0.254 0.640
Maximum 58.712 38.636 26.288
Mean 28.043 5.519 2.388
Median 26.515 1.462 1.239
SD 12.373 9.614 5.232
CV% 44.121 174.211 219.081
N 29 26 23
NA= Not available

Table 16: Plasma L-glutamine Amino Acid Estimation for All Enrolled Patients
Time (day)
0.00 15.00 22.00
1 T 1611.301 1113.014 578.767
2 R 748.288 688.356 1481.164
3 T 1065.068 912.671 904.110
4 R 972.603 811.644 902.397
5 R 953.767 380.137 NA
6 T 172.945 NA NA
7 R 251.712 NA NA
8 T 1385.274 840.753 1654.110

9 R 1000.000 1482.877 969.178
10 T 1292.808 1097.603 934.932
11 T 1090.753 875.000 731.164
12 R 1488.014 NA NA
13 T 919.521 1224.315 1114.726

14 R 1952.055 719.178 866.438
15 T 1969.178 556.507 1001.712
16 R 702.055 976.027 345.890
17 R 851.027 529.110 534.247
18 T 714.041 347.603 NA
19 R 1126.712 354.452 1034.247
20 T 2910.959 1900.685 1866.438
21 R 729.452 546.233 1077.055
22 T 1049.658 476.027 NA
23 T 994.863 784.247 558.219
24 R 1320.205 597.603 453.767
25 R 1422.945 698.630 2054.795
26 T 1053.082 1080.479 746.575
27 R 503.425 503.425 796.233

28 R 1215.753 928.082 912.671

29 T 905.822 880.137 818.493
Minimum 172.945 347.603 345.890
Maximum 2910.959 1900.685 2054.795
Mean 1116.320 819.415 971.188
Median 1049.658 797.945 904.110
SD 539.543 359.285 431.697
CV% 48.332 43.847 44.450
N 29 26 23
NA= Not available

Table 17: Plasma L-aspartic Acid Estimation for All Enrolled Patients
Time (day)
0.00 15.00 22.00
1 T 8.985 13.308 9.887
2 R 16.015 31.278 45.113
3 T 5.827 21.165 11.917
4 R 5.150 9.323 14.023
5 R 7.632 5.602 NA
6 T 1.271 NA NA
7 R 2.440 NA NA
8 T 9.925 23.195 29.248

9 R 6.992 12.744 7.970
10 T 6.579 14.812 11.955
11 T 4.586 11.429 4.699
12 R 17.820 NA NA
13 T 7.707 15.602 11.767

14 R 7.895 9.398 14.586
15 T 25.714 39.098 30.451
16 R 20.451 23.722 22.744
17 R 20.902 26.805 38.722
18 T 6.955 4.812 NA
19 R 3.947 6.729 18.120
20 T 29.135 37.293 25.038
21 R 9.060 16.316 21.541
22 T 6.767 17.820 NA
23 T 10.150 7.368 8.045
24 R 25.113 32.331 39.474
25 R 25.038 23.271 36.617
26 T 16.692 28.383 23.233
27 R 8.158 19.887 27.895

28 R 17.820 29.549 23.872

29 T 4.925 6.842 4.850
Minimum 1.271 4.812 4.699
Maximum 29.135 39.098 45.113
Mean 11.712 18.772 20.946
Median 8.158 17.068 21.541
SD 7.885 10.112 11.781
CV% 67.328 53.867 56.246
N 29 26 23
NA= Not available

Table 18: Plasma L-glutamic Acid Estimation for All Enrolled Patients
Time (day)
0.00 15.00 22.00
1 T 57 50 47
2 R 17 26 51
3 T 41 56 60
4 R 43 47 76
5 R 40 17 NA
6 T 6 NA NA
7 R 11 NA NA
8 T 55 61 185
9 R 47 72 73
10 T 46 51 52
11 T 49 51 62
12 R 58 NA NA
13 T 34 92 88
14 R 88 78 98
15 T 42 36 31
16 R 35 30 41
17 R 21 42 59
18 T 36 16 NA
19 R 46 25 63
20 T 63 39 57
21 R 35 58 99
22 T 46 32 NA
23 T 48 71 62
24 R 31 17 20
25 R 33 29 57
26 T 34 29 22
27 R 18 16 21

28 R 28 37 53
29 T 59 44 38
Minimum 6.224 15.612 19.966
Maximum 87.755 92.177 185.034
Mean 40.240 43.189 61.488
Median 41.497 40.476 57.483
SD 17.077 20.329 34.665
CV% 42.438 47.069 56.376
N 29 26 23
NA= Not available

14.2.2 Patients Data for Primary and Secondary Outcome Evaluation

The evaluable patients of test and reference Pegaspargase formulation were
assessed for pharmacokinetic and statistical analysis.
Table 19: Ratio Analysis of Cmax (ng/ml)
Cmax AUC0-t Tmax Thalf Vd Cl
Patient
(IU/L) (hr*IU/L) (hr) (hr) (L) (L/hr)
1 397.09 83098.414 48.00 132.09 6.662 0.035
3 391.16 67322.599 48.00 136.97 8.584 0.043
10 440.91 76311.180 48.00 254.51 9.979 0.027
11 576.23 95928.842 48.00 153.24 6.426 0.029
13 532.68 96416.013 48.00 194.49 7.172 0.026
15 484.07 90644.220 48.00 104.62 5.335 0.035
18 481.53 65744.904 48.00 158.46 10.119 0.044
20 374.78 73654.862 48.00 133.81 7.501 0.039
26 203.87 39294.385 48.00 189.78 17.030 0.062
29 517.92 76895.812 48.00 94.81 5.878 0.043
Minimum 203.87 39294.385 48.00 94.81 5.335 0.026
Maximum 576.23 96416.013 48.00 254.51 17.030 0.062
Mean 440.02 76531.123 48.00 155.28 8.469 0.038
Median 461.22 76603.496 48.00 145.10 7.337 0.037
SD 106.00 17029.900 0.00 47.31 3.414 0.011
CV% 24.090 22.252 0.00 30.47 40.314 28.093
Geometric Mean 425.36 74457.371 48.00 149.23 7.994 0.037
N 10 10 10 10 10 10

Table 20: Pharmacokinetic Parameters for Reference Formulation (R)

of Pegaspargase
Cmax AUC0-t Tmax Thalf Vd Cl
Patient
(IU/L) (hr*IU/L) (hr) (hr) (L) (L/hr)
2 438.49 87698.755 48.00 123.23 6.042 0.034
4 235.03 43702.987 48.00 166.71 14.718 0.061
9 170.21 39365.366 120.00 277.32 19.787 0.049
14 428.78 79459.872 48.00 157.22 7.779 0.034
16 617.66 101916.700 48.00 82.28 3.946 0.033
17 580.41 112886.670 48.00 167.46 5.720 0.024
19 591.43 87025.463 48.00 112.71 5.879 0.036
21 348.31 65303.190 48.00 58.82 4.695 0.055
24 541.77 113165.370 48.00 152.40 5.254 0.024
27 527.02 88475.132 48.00 88.91 4.893 0.038
28 383.41 86879.886 48.00 140.90 6.628 0.033
Minimum 170.21 39365.366 48.00 58.82 3.946 0.024
Maximum 617.66 113165.370 120.00 277.32 19.787 0.061
Mean 442.05 82352.672 54.55 138.91 7.758 0.038
Median 438.49 87025.463 48.00 140.90 5.879 0.034
SD 147.86 24522.753 21.71 58.58 4.934 0.012
CV% 33.450 29.778 39.80 42.18 63.597 31.466
Geometric Mean 413.73 78337.872 52.17 128.39 6.807 0.037
N 11 11 11 11 11 11

Table 21: Confidence Intervals and Final Variance Parameters for

Ratio of L-Asparaginase Activity for Pegaspargase
Least square Geometric 90% Confidence

Means Intervals T/R Inter
Power
Parameter Ratio Patient
(%)
Test Reference Lower Upper (%) CV (%)
(T) (R) (%) (%)
Ln AUC0-t
74457.3708 78337.8720 75.07 120.33 95.05 46.3 32.0
(hr*IU/L)
Table 22: ANOVA for Ln (AUC0-t) of L-Asparaginase activity for Pegaspargase
Source DF Sum of Squares Mean Square F Value Pr > F

Model 1 0.0135 0.0135 0.14 0.7137
Error 19 1.8525 0.0975
Corrected Total 20 1.8660
R-Square Coeff Var Root MSE lnAUCt Mean

0.0072 2.7769 0.3122 11.2446
Source DF Type III SS Mean Square F Value Pr > F

Trt 1 0.0135 0.0135 0.14 0.7137
Standard
Parameter Estimate Error t Value Pr > |t| 90% Confidence Limits
T Vs R -0.05080441 0.13642998 -0.37 0.7137 -0.28670996 0.18510115

Table 23: Summary for Anti L-asparaginase antibodies Levels

Time (day)
Pre-dose Post-dose Change Pre-dose
Patient Drug Antibodies Levels (ng/mL)
1 T -0.756 -1.011 -0.255
2 R 5.691 -0.097 -5.789
3 T -0.060 -1.016 -0.956
4 R -0.946 0.209 1.155
9 R 9.007 5.042 -3.966
10 T 2.101 -0.042 -2.143
11 T 2.295 0.212 -2.083
13 T -0.275 -0.748 -0.473
14 R 0.699 -0.562 -1.262
15 T -0.864 -1.086 -0.223
16 R 1.409 -0.553 -1.962
17 R 0.333 -0.887 -1.220
18 T -0.803 NA NA
19 R -0.228 -0.163 0.065
20 T -0.975 3.543 4.518
21 R 10.107 1.144 -8.963
24 R -0.446 -0.299 0.147
26 T 1.540 -0.392 -1.932
27 R 8.986 0.615 -8.371
28 R 0.170 -0.632 -0.802
29 T 4.079 -0.104 -4.183
Minimum -0.975 -1.086 -8.963
Maximum 10.107 5.042 4.518
Mean 1.956 0.159 -1.935
Median 0.333 -0.231 -1.241
SD 3.547 1.541 3.125
CV% 181.366 971.784 -161.502
N 21 20 20

Table 24: Wilcoxon Scores (Rank Sums) for Comparison of Development of L-

asparaginase Antibodies.
Wilcoxon Scores (Rank Sums) for Variable CHANGE Classified by Variable

Treatment
Sum of Expected Std dev Mean
Treatment N
Scores Under H0 Under H0 Score
Test 9 86.0 94.50 13.162447 9.555556
Reference 11 124.0 115.50 13.162447 11.272727
Wilcoxon Two-Sample Test

Statistic 86.0000
Normal Approximation
Z -0.6458
One-Sided Pr < Z 0.2592
t Approximation
One-Sided Pr < Z 0.2631

Table 25: Summary for L-asparagine (Amino Acid) Levels
Sample
1 T 19.886 1.239 -18.648
2 R 16.023 0.932 -15.091
3 T 19.545 1.360 -18.186
4 R 34.811 1.136 -33.674
9 R 26.364 1.341 -25.023
10 T 30.795 1.337 -29.458
11 T 29.015 0.693 -28.322
13 T 26.515 1.235 -25.280
14 R 45.076 1.470 -43.606
15 T 43.182 1.170 -42.011
16 R 19.735 1.265 -18.470
17 R 19.697 1.341 -18.356
18 T 25.189 NA NA
19 R 22.311 1.197 -21.114
20 T 58.712 0.818 -57.894
21 R 29.280 1.473 -27.807
24 R 34.924 1.193 -33.731
26 T 20.379 1.011 -19.367
27 R 7.689 1.095 -6.595
28 R 24.735 1.973 -22.761
29 T 25.720 26.288 0.568
Minimum 7.689 0.693 -57.894
Maximum 58.712 26.288 0.568
Mean 27.599 2.478 -25.241
Median 25.720 1.237 -23.892
SD 11.217 5.611 13.024
CV% 40.642 226.375 -51.598
N 21 20 20

Table 26: Wilcoxon Scores (Rank Sums) for Comparison of Change in the Levels of L-
asparagine.

Treatment
Treatment N
Test 9 99.0 94.50 13.162447 11.0000
Reference 11 111.0 115.50 13.162447 10.090909

Statistic 99.0000
Z 0.3419
One-Sided Pr > Z 0.3662
t Approximation

Table 27: Summary for L-glutamine (Amino Acid) Levels
Sample
1 T 1611.301 578.767 -1032.534
2 R 748.288 1481.164 732.877
3 T 1065.068 904.110 -160.959
4 R 972.603 902.397 -70.205
9 R 1000.000 969.178 -30.822
10 T 1292.808 934.932 -357.877
11 T 1090.753 731.164 -359.589
13 T 919.521 1114.726 195.205
14 R 1952.055 866.438 -1085.616
15 T 1969.178 1001.712 -967.466
16 R 702.055 345.890 -356.164
17 R 851.027 534.247 -316.781
18 T 714.041 NA NA
19 R 1126.712 1034.247 -92.466
20 T 2910.959 1866.438 -1044.521
21 R 729.452 1077.055 347.603
24 R 1320.205 453.767 -866.438
26 T 1053.082 746.575 -306.507
27 R 503.425 796.233 292.808
28 R 1215.753 912.671 -303.082
29 T 905.822 818.493 -87.329
Minimum 503.425 345.890 -1085.616
Maximum 2910.959 1866.438 732.877
Mean 1174.005 903.510 -293.493
Median 1053.082 903.253 -304.795
SD 551.972 340.064 502.613
CV% 47.016 37.638 -171.252
N 21 20 20

Table 28: Wilcoxon Scores (Rank Sums) for Comparison of Change in the Levels of
L-glutamine.

Treatment
Treatment N
Test 9 114.0 94.50 13.162447 12.66667
Reference 11 96.0 115.50 13.162447 8.727273

Statistic 114.0000
Z 1.4815
t Approximation

14.2.3 Graphs of L-Asparaginase activity

The 21 evaluable patients of test and reference Pegaspargase formulation were assessed
for pharmacokinetic and statistical analysis. The graphical representation of 21 patients is
shown below:
Figure 1: Linear Plot of Mean Plasma Activity versus Time for all evaluable patients
Figure 2: Semi-log Plot of Mean Plasma Activity versus Time for all evaluable
Patients


Figure 3: Patient 1 Linear Plot of Plasma Activity versus Time
Figure 4: Patient 1 Semi-log Plot of Plasma Activity versus Time





















14.3 Safety Data

14.3.1 Display of Adverse Events
Table 29: Display of Adverse Events
Patient No Adverse Event Start Date Start Time Stop Date Stop Time Severity Causality Outcome
Fever 22/02/2016 01:00 23/02/2016 08:00 Grade 1- Mild Unrelated Recovered without sequel
Fever 01/03/2016 09:00 04/03/2016 12:00 Moderate Unrelated Recovered without sequel
2 Epigastric pain 11/03/2016 11:00 14/03/2016 10:00 Moderate Unrelated Recovered without sequel
Vomiting 24/02/2016 UNK 26/02/2016 UNK Moderate Unrelated Recovered without sequel
Fever 16/03/2016 UNK 21/03/2016 UNK Moderate Possible Recovered without sequel
Vomiting 09/03/2016 10:00 09/03/2016 14:00 Mild Probable Recovered without sequel
Vomiting & Loose motions 17/03/2016 11:00 17/03/2016 18:00 Moderate Possible Recovered without sequel
3
Elevated LFT/RFT values 22/03/2016 10:30 29/03/2016 11:00 Mild Probable Recovered without sequel
Low platelet count 22/03/2016 10:30 22/03/2016 18:00 Mild Definite Recovered without sequel
4 Cough, Cold 19/03/2016 11:00 21/03/2016 11:00 Mild Unrelated Recovered without sequel
Constipation 02/04/2016 09:00 04/04/2016 13:45 Mild Unrelated Recovered without sequel
5 Vomiting 05/04/2016 10:00 05/04/2016 15:00 Mild Unrelated Recovered without sequel
6 Diarrhea/G.I.Sepsis 20/05/2016 03:01 26/05/2016 05:14 Moderate Possible Recovered without sequel
7 Vomiting 25/05/2016 17:30 26/05/2016 09:00 Mild Unrelated Recovered without sequel
8
Fever 10/06/2016 10:00 11/06/2016 05:00 Moderate Possible Recovered without sequel
9 Fever 01/11/2016 19:00 03/11/2016 02:00 Moderate Unrelated Recovered with sequel
10 Fever 03/11/2016 09:00 04/11/2016 09:30 Moderate Unrelated Recovered without sequel

Patient No Adverse Event Start Date Start Time Stop Date Stop Time Severity Causality Outcome
Cough, Cold 13/11/2016 15:00 16/11/2016 14:00 Mild Unrelated Recovered without sequel
15
Fever 30/12/2016 12:30 30/12/2016 16:00 Mild Unrelated Recovered without sequel
16 Fever 24/01/2017 16:00 25/01/2017 10:00 Moderate Possible Recovered with sequel
17 Perianal Pain 29/01/2017 09:00 30/01/2017 10:00 Moderate Unrelated Recovered without sequel
Loose motions 09/12/2017 05:00 09/12/2017 16:00 Moderate Unlikely Recovered without sequel
27
Fever 17/12/2017 08:00 20/12/2017 10:00 Moderate Possible Recovered without sequel
14.3.1.1 Summary of Concomitant Medication
Table 30: Summary of Concomitant Medication

Generic Name of the Ongoin
Patient No Dose Frequency Route Indication Date Started Date Stopped
drug g
Syp Rantac 2 ml BD PO Acidity 05-02-2016 15-02-2016
Cap. Heptos 200 mg BD ½-0-½ PO Viral prophylaxis 13-02-2016 Yes
Syp Mucopine LA 20% TDS PO Mucositis 15-02-2016 22-02-2016
Oflaxin Ear drops TDS Otic Ear discharge 15-02-2016 22-02-2016
Tab Forcan 100 mg OD PO Fungal Infection 15-02-2016 18-02-2016
1 88% Glycerine
BG Paint w/w + TDS Topical Mucositis 15-02-2016 22-02-2016
12% Borax w/w
Tab Cetrizine 5 mg OD PO Allergy 12-02-2016 15-02-2016
Inj Magnex 1.2 gm TDS IV Infection 16-02-2016 22-02-2016
Inj Amikacin 250 mg OD IV Infection 16-02-2016 22-02-2016
Inj Clinda 150 mg TDS IV Fungal infection 16-02-2016 22-02-2016


drug g
Tab Vorizol 150 mg BD PO Fungal infection 16-02-2016 Yes
Syp Kesol 7 ml TDS PO Hypokalemia 17-02-2016 25-02-2016
Inj Zienam 375 mg Stat IV Infection 17-02-2016 22-02-2016
2.5 MU then 8.5
Inj Colistin TDS IV Bacterial infection 26-02-2016 07-03-20 16
MU
Inj Meropenem 680 mg TDS IV Fever 26-02-2016 15-03-2016
Inj Targocid 170 mg OD IV Infection 26-02-2016 04-03-2016
Inj Amphotericin B 15 mg OD IV Fungal sinitis 26-02-2016 08-03-2016
Tab Ribavirin 200 mg BD PO Viral prophylaxis 26-02-2016 07-03-2016
Syp Kesol 7.5 ml TDS PO Hypokalemia 27-02-2016 08-03-2016
Inj Perfalgan 20 ml SoS IV Fever 27-02-2016 09-03-2016
Tab Phlogam 238 mg BD PO Muscle relaxation 27-02-2016 02-03-2016
Tab Marex 20 mg BD PO Allergy 04-03-2016 05-03-2016
Otrivin p-nasal drops 0.1% QID Intranasal Congestion 04-03-2016 14-03-2016
Tab Amlodipin 2.5 mg BD PO Hypertension 09-03-2016 Yes
Inj Linezolid 150 mg TDS IV Infection 09-03-2016 14-03-2016
Inj Levera 150 mg BD IV Seizures 09-03-2016 14-03-2016
Syp Levere 1.5 ml OD PO Seizures 15-03-2016 22-03-2016
Inj Caspofungin 50 mg then 35 mg OD IV Fungal infection 09-03-2016 15-03-2016
Syp Kesol 5 ml TDS PO Hyperkalemia 16-03-2016 22-03-2016
Inj Cytarabine 1350 mg OD IV CNS Prophylaxis 17-03-2016 18-03-2016
Inj Ondem 4 mg BD IV Vomiting 16-03-2016 16-03-2016
Inj Dexa 2 mg BD IV Allergy 16-03-2016 16-03-2016
Tab Blong 40 mg BD PO High cholesterol 17-03-2016 22-03-2016


drug g
Tab 6-MP 50 mg HS PO Chemodrug 17-03-2016 23-03-6201
Ribovarin 100 mg BD PO Prophylaxis 15-03-2016 Yes
Acivir 200 mg TDS PO Antiviral 16-02-2016 17-02-2016
Inj Magnex forte 2.5 gm Stat IV Infection 22-02-2016 22-02-2016
Inj Amikacin 350 mg Stat IV Infection 22-02-2016 22-02-2016
Tab Monocef 100 mg BD PO Infection 22-02-2016 22-02-2016
Syp Fluvir 3.5 ml BD PO Infection 22-02-2016 22-02-2016
Inj Emeset 5 mg SoS IV Vomiting 23-02-2016 23-02-2016
Tab Rantac 150 mg BD PO Acidity 23-02-2016 29-02-2016
Tab Vorizol 200 mg BD PO Fungal infection 23-02-2016 03-03-2016
Tab Domestal 10 mg BD PO Vomiting 24-02-2016 26-02-2016
Tab Ondem 4 mg TDS PO Vomiting 24-02-2016 26-02-2016
Tab Azee 250 mg OD PO Antibiotic 24-02-2016 27-02-2016
2
Syp Cough-ex 2.5 ml TDS PO Cough 25-02-2016 27-02-2016
Syp Tamiflu 3.5 ml BD PO Infection 25-02-2016 30-02-2016
Inj Magnex forte 2 mg BD IV Fever 01-03-2016 05-03-2016
Inj Amikacin 600 mg OD IV Fever 01-03-2016 05-03-2016
Tab Ribavirin 200 mg BD PO Viral prophylaxis 01-03-2016 08-03-2016
Syp Duphalac 10 ml BD PO Constipation 01-03-2016 04-03-2016
Inj Grafeel 0.20 cc OD IV Febrile neutropenia 03-03-2016 10-03-2016
Syp Dulphalac 15 ml TDS PO Constipation 08-03-2016 11-03-2016
Tab Domestal 10 mg BD PO Pain 11-03-2016 14-03-2016


drug g
Syp Duphalac 10 ml TDS PO Constipation 14-03-2016 16-03-2016
Inj Magnex forte 2.2 gm BD IV Fever 16-03-2016 21-03-2016
Tab Ranitidine 75 mg BD PO Acidity 08-03-2016 11-03-2016
Inj Ondem 4 mg Stat IV Vomiting 08-03-2016 08-03-2016
Tab Vorizole 200 mg BD PO Fungal Prophylaxis 08-03-2016 22-03-2016
Tab Acivir 200 mg TDS PO Prophylaxis 09-03-2016 14-03-2016
Inj Graniset 0.8 mg Stat IV Premed 09-03-2016 09-03-2016
3 Inj DNS 500 cc 500 cc Stat IV Hydration 10-03-2016 17-03-2016
Syp Posaconazole 5 ml TID PO Prophylaxis 22-03-2016 28-03-2016
Tab Adliv fort 150 mg BD PO Liver supplement 22-03-2016 26-03-2016
Inj Graniset 0.8 mg Stat IV Premed 17-03-2016 17-03-2016
Inj DNS 500 cc 500 cc Stat IV Hydration 17-03-2016 17-03-2016
Inj Magnex forte 3 mg TDS IV Infection 26-03-2016 28-03-2016
Tab Calpol-T 500 mg SoS PO Fever 26-03-2016 31-03-2016
Syp Posaconazole 40
5 ml TDS PO Prophylaxis 26-03-2016 30-03-2016
mg
4 Tab Septran 480 mg OD PO Prophylaxis 26-03-2016 27-03-2016
Syp Duphalac 20 ml OD PO Constipation 07-04-2016 Yes
Inj Meropenem 1gm TDS IV Fever 28-03-2016 10-04-2016
Syp Cremaffin 10 ml TDS PO Acidity 30-03-2016 Yes
Tab Amlodipine 2.5 mg OD PO High BP 30-03-2016 Yes


drug g
Inj Caspofungin 50 mg in 100 ml OD IV Fungal infection 31-03-2016 11-04-2016
Tab Enalapril 25 mg BD PO High BP 31-03-2016 Yes
Inj Teicoplanin 400 mg OD IV Antibiotic 31-03-2016 10-04-2016
Tab Azithromycin 500 mg OD PO Antibiotic 31-03-2016 04-04-2016
Inj Paracetamol 600 mg SoS IV Fever 31-03-2016 02-04-2016
Inj Tramadol 50 mg SoS IV Pain 01-04-2016 10-04-2016
Syp Posaconazole 5 ml TDS PO Prophylaxis 18-03-2016 26-03-2016
Tab Citrizine 5 mg BD PO Cold 19-03-2016 19-03-2016
Syp Grilinctus 6 ml TDS PO Cold 19-03-2016 21-03-2016
Syp Cremaffin 15 ml TDS PO Constipation 31-03-2016 10-04-2016
Inj Laxopeg 17 gms OD IV Constipation 30-03-2016 30-03-2016
Tab Sepran 20 mg/1 kg 2 tab QID PO Prophylaxis 31-03-2016 Yes
Syp Posaconazole 5 ml TID PO Prophylaxis 11-04-2016 Yes
Tab Rantac 150 mg BD PO Acidity 11-04-2016 Yes
Tab Acyclovir 400 mg TDS PO Prophylaxis 21-03-2016 21-03-2016
Tab Antithromycin 250 mg OD PO Antibiotic 23-03-2016 27-03-2016
Inj Granisetron 0.8 mg OD IV Premed 29-03-2016 29-03-2016
5
Tab Vorizol 200 mg BD PO Prophylaxis 30-03-2016 02-05-2016
Tab Calpal-T 500 mg SoS PO Fever 01-04-2016 04-04-2016


drug g
Syp Dulphalac 10 ml TDS PO Constipation 04-04-2016 11-04-2016
Inj Tramadol 30 mg OD IV Pain 05-04-2016 05-04-2016
Tab Domestal 5 mg TDS PO Vomiting 05-04-2016 07-04-2016
Tab Ondem 8 mg TDS PO Vomiting 05-04-2016 06-04-2016
Suspension Smith 10 ml TDS PO Constipation 05-04-2016 06-04-2016
Inj Magnex forte 2.5 mg Stat IV Fever 05-04-2016 05-04-2016
Inj Amikacin 330 mg OD IV Antibiotic 05-04-2016 05-04-2016
Inj Granisetron 1.5 mg OD IV Premed 06-04-2016 06-04-2016
Inj Magnex forte 2.5 mg TDS IV Fever 06-04-2016 11-04-2016
Tab Veenat 200/300 mg OD PO ALL 07-04-2016 14-04-2016
Cap Evion 2 capsules TDS PO Vitamin supplement 07-04-2016 22-04-2016
Stomacare LA 1% TDS Topical Mucositis 07-04-2016 14-04-2016
Inj Perinorm 2 mg Stat IV Premed 10-04-2016 10-04-2016
Inj Graniset 2 mg OD IV Premed 10-04-2016 13-04-2016
Inj Graniset 2 mg OD IV Febrile neutropenia 10-04-2016 20-04-2016
Inj Metrogyl 200 mg TDS IV Antibiotic 10-04-2016 14-04-2016
Inj Meropenem 500 mg TDS IV Infection 11-04-2016 04-05-2016
Inj Colistin 1 mg TDS IV Antibiotic 11-04-2016 04-05-2016
Inj Tigecycline 50 mg BD IV Antibacterial 11-04-2016 25-04-2016
Inj Tranexa 200 mg TDS IV Bleeding 11-04-2016 14-04-2016
Inj Fentanyl 10 mg/cc OD IV Pain 12-04-2016 19-04-2016
Inj Vit.k 5 mg OD IV Vit supplement 11-04-2016 13-04-2016


drug g
Inj Targocid 210 mg OD IV Infection 13-04-2016 03-05-2016
Syp Kesol 1 TSP SoS PO Vit K Supplement 15-04-2016 01-05-2016
Inj Midaz 2 mg OD IV Sedation 15-04-2016 16-04-2016
Inj
2 mg BD IV 15-04-2016 16-04-2016
Vecuronium Anaesthesia
2.5 cc kcl + 2.5
Inj KCL OD IV Hypokalemia 15-04-2016 16-04-2016
ml NS
Phospho sachets 228 mg OD RT Diarrhoea 17-04-2016 22-04-2016
Inj Vit.k 5 mg OD IV Vit k supplement 17-04-2016 22-04-2016
Inj Lasix 5 mg Stat IV stat Edema 17-04-2016 17-04-2016
Inj Phosphos 5 ml OD IV Hypo phosphate 10-04-2016 17-04-2016
Tab Naproxen 220 mg SoS ½-0-½ PO Inflammation 18-04-2016 01-05-2016
Inj Midaz 2 mg OD IV Amnesia 18-04-2016 18-04-2016
Inj Albumin
20% with 10 mg OD IV Low protein 19-04-2016 20-04-2016
20%
Inj Lasix 2.5 mg stat Stat IV Edema 19-04-2016 19-04-2016
Inj Dexan 10 OD IV Sedation 19-04-2016 22-04-2016
Tab Evion 2 tabs TDS PO Vit supplement 23-04-2016 04-05-2016
Inj Perinorm 5 mg TDS IV Vomiting 24-02-2016 02-05-2016
Inj Lasix 5 mg Stat IV Edema 23-04-2016 23-04-2016
Tab Vanilid 125 mg QID PO Hyper sensitivity 22-04-2016 30-04-2016
Syp A to Z 3 ml TDS PO Vit Deficiency 25-04-2016 04-05-2016
Inj Morphine 1 ml OD IV Pain 20-04-2016 03-05-2016
Inj Lasix 10 mg BD IV Edema 01-05-2016 03-05-2016


drug g
Inj Vec 2 mg Stat IV stat Anaesthesia 02-05-2016 02-05-2016
Inj IVIG 10 gm OD IV Antibody deficiency 27-04-2016 27-04-2016
Inj Avil 0.5 ml OD IV Allergy 27-04-2016 27-04-2016
Inj Hydrocort 20 mg OD IV Allergy 27-04-2016 27-04-2016
Syp Zinetac 5 ml BD PO Acidity 17-05-2016 26-05-2016
Inj Tramadol 50 mg OD IV Pain abdomen 20-05-2016 20-05-2016
Inj Magnex forte 3 gm BD IV Diarrhea/GI Sepsis 20-05-2016 23-05-2016
Inj Amikacin 750 mg OD IV Diarrhea/GI Sepsis 20-05-2016 21-05-2016
Inj Meropenem 1 gm Stat IV GI Sepsis 26-05-2016 26-05-2016
Inj Targocid 500 mg Stat IV GI Sepsis 26-05-2016 26-05-2016
6 Tab Lorizole 200 mg BD PO Prophylaxis 17-05-2016 26-05-2016
Inj Ondanosetron 8 mg OD IV Prophylaxis 25-05-2016 25-05-2016
Inj Amikacin 750 mg OD IV Prophylaxis 26-05-2016 26-05-2016
Inj Fentanyl 100 mg Stat IV Pain 26-05-2016 26-05-2016
Inj Midaz 1 mg Stat IV Sedation 26-05-2016 26-05-2016
Inj Ketamine 80 mg Stat IV Anaesthesia 26-05-2016 26-05-2016
Inj Adrenaline 1 mg/6 mg Stat IV Inotropic agent 26-05-2016 26-05-2016
Inj NAHCO3 20 ml/hr Stat IV Inotropic agent 26-05-2016 26-05-2016
Inj Vassopression 20 unit Stat IV Inotropic agent 26-05-2016 26-05-2016
Tab Emset 8 mg TDS PO Prophylaxis for vomiting 25-05-2016 25-05-2016
7
Tab Domstal 5 mg BD PO Prophylaxis for vomiting 25-05-2016 27-05-2016


drug g
Inj Ondem 8 mg OD IV Prophylaxis 26-05-2016 26-05-2016
Tab Amlodepin 2.5 mg BD PO Hypertension 28-05-2016 02-06-2016
Inj Megnex 3 gm Stat IV GI Sepsis 02-06-2016 02-06-2016
Inj Graniset 1.3 mg Stat IV GI Sepsis 02-06-2016 02-06-2016
Inj Pantop 25 mg BD IV GI Sepsis 02-06-2016 02-06-2016
Tab Metrogyl 400 mg TDS PO GI Sepsis 02-06-2016 02-06-2016
Syp Zincorial 5 ml OD PO GI Sepsis 02-06-2016 02-06-2016
Inj Vit.k 5 mg Stat IV GI Sepsis 02-06-2016 02-06-2016
Inj Tranexa 350 mg Stat IV GI Sepsis 02-06-2016 02-06-2016
Inj Meropenem 1 gm TDS IV GI Sepsis 03-06-2016 03-06-2016
Inj Targocid 300 mg OD IV GI Sepsis 03-06-2016 03-06-2016
Inj Hydrocort 200 mg Stat IV GI Sepsis 03-06-2016 03-06-2016
Inj Colistin 6 MU Stat IV GI Sepsis 03-06-2016 03-06-2016
Tab Azee 500 mg OD PO Antibiotic for fever 27-05-2016 31-05-2016
Syp Grilinctus 7.5 ml TDS PO Cough 27-05-2016 29-05-2016
Tab Neurogen forte 650 mg TDS PO Pain 28-05-2016 30-05-2016
8
Paracetamol 1 gm stat IV Fever 28-05-2016 28-05-2016
Tab Primolut-N 5 mg TDS PO Polymonorrhagia 27-05-2016 Yes


drug g
Tab Flucon 200 mg OD PO Fungal infection 06-06-2016 10-06-2016
Tab Acivir 400 mg TDS PO Viral infection 06-06-2016 10-06-2016
Tab Norflox 400 mg TDS PO Fever 10-06-2016 11-06-2016
Inj Meropenem 1 gm TDS IV Febrile neutropenia 11-06-2016 21-06-2016
Inj Amikacin 850 mg OD IV Febrile neutropenia 11-06-2016 17-06-2016
Inj Vorizol 300 mg BD PO Fungal sinisitis 11-06-2016 11-06-2016
Inj Teicoplanin 400 mg OD IV Antibiotic 13-06-2016 17-06-2016
Inj Liposomal
150 mg OD IV Fungal infection 13-06-2016 24-06-2016
Amphotericin-B
Mineracorticoid
Tab Aldactone 25 mg BD PO 18-06-2016 24-06-2016
replacement
Inj Meropenem 500 mg TDS IV Antibiotic/fever 02-11-2016 14-11-2016
Inj Amikacin 400 mg OD IV Antibiotic/fever 02-11-2016 09-11-2016
Tab Flucon 200 mg OD PO Antifungal 02-11-2016 22-11-2016
Tab Citrizine 50 mg HS PO Cold allergy 11-11-2016 14-11-2016
Inj Colistin 3.5 MU TDS IV Antibiotic 09-11-2016 26-11-2016
Inj PCM 250 mg QID IV Fever 10-11-2016 13-11-2016
9
Inj Fluconazole 200 mg OD IV Fungal infection 11-11-2016 14-11-2016
Inj Granisetron 1 mg OD IV Vomiting 15-11-2016 15-11-2016
Inj Meropenem 500 mg TDS IV Antibiotic 16-11-2016 30-11-2016
Tab Fluconazole 200 mg OD PO Fungal infection 18-11-2016 23-11-2016
Inj Amenikacin 400 mg OD IV Fever 18-11-2016 19-11-2016
Tab Azee 250 mg OD PO Fungal pneumonia 19-11-2016 24-11-2016


drug g
Inj Tranesea 250 mg TDS IV Coagulant 22-11-2016 25-11-2016
Inj Vit.k 5 mg OD IV Bleeding 22-11-2016 24-11-2016
Tab Nurogen forte 10 mg Stat PO Pain 24-11-2016 24-11-2016
Inj Lasix 10 mg Stat IV Salt management 24-11-2016 24-11-2016
Tab Monocef 200 mg BD PO Fever 25-10-2016 01-11-2016
Tab Calpol 500 mg SoS PO Fever 25-10-2016 25-10-2016
Tab Zinetac 150 mg BD PO Acidity 26-10-2016 Yes
Cap Fluvir 75 mg BD PO Prophylaxis 27-10-2016 06-11-2016
Tab Acivir 400 mg BD PO Prophylaxis 27-10-2016 03-11-2016
Tab Shelcal 250 mg OD PO Calcium supplement 02-11-2016 19-12-2016
10 Inj Magnex forte 3 mg OD IV Fever 03-11-2016 09-11-2016
Tab Cetrizine 10 mg BD PO Allergy 03-11-2016 08-11-2016
Inj Magnex forte 3 gm BD IV Fever 14-11-2016 17-11-2016
Inj Amikacin 50 mg BD IV Fever 14-11-2016 17-11-2016
Tab Calpol 500 mg Stat PO Fever 15-11-2016 15-11-2016
Syp Azee 200 mg/5 ml OD PO Antibiotic 15-11-2016 17-11-2016
Syp Cortex 2 tsp TDS PO Cough 14-11-2016 17-11-2016
Tab Vorizol 200 mg BD PO Fungal prophylaxis 28-10-2016 09-11-2016
11
Tab Acivir 200 mg BD PO Prophylaxis 28-10-2016 09-11-2016
Inj Megnex forte 3 gm BD IV Fever 08-11-2016 11-11-2016


drug g
Tab Calpol 250 mg Stat PO Fever 08-11-2016 08-11-2016
Inj Megnex forte 3 gm BD IV Fever 16-11-2016 16-11-2016
Inj Meropenem 850 mg TDS IV Fever 17-11-2016 01-12-2016
Inj Liposomal
140 mg OD IV Fungal infection 17-11-2016 25-11-2016
Amphotericin-B
Inj Targocid 300 mg OD IV Antibiotic 17-11-2016 01-12-2016
Tab Vorizole 200 mg OD PO Fungal infection 17-11-2016 Yes
Cap Yogurt 1-10 billion CFU TDS PO Probiotic 23-11-2016 Yes
Tab Acivir 200 mg BD PO Prophylaxis 17-11-2016 Yes
Bacterial infection
Tab Septran 480 mg BD PO 24-11-2016 Yes
prophylaxis
TIT is Triple
Intrathecal dose
CNS
12 TIT of 28-10-2016 28-10-2016
prophylaxis
chemotherapy
drug
Tab Ranitidine 150 mg BD PO Antacid 31-10-2016 08-11-2016
Inj Tramadol 30 mg Stat IV stat Pain 08-11-2016 08-11-2016
Inj Megnex forte 3 mg Stat IV stat Fever 08-11-2016 08-11-2016
Inj Targocid 300 mg BD IV Fever 08-11-2016 11-11-2016
Inj Meropenem 1200 mg TDS IV Infection 08-11-2016 11-11-2016
Inj PCM 35 ml Stat IV stat Pain 08-11-2016 08-11-2016


drug g
Inj Dexan 10 gm OD IV Steroid 09-11-2016 11-11-2016
Inj PAN 30 mg OD IV Acidity 08-11-2016 11-11-2016
Inj Ca.gluconate 10%
940 mg Stat IV stat Hypocalcaemia 08-11-2016 08-11-2016
10 ml
Inj Midaz 2 mg+ 2 mg Stat IV stat IT intubation 09-11-2016 09-11-2016
Inj Kcl 5 cc/25 Stat IV stat Hypokalemia 10-11-2016 10-11-2016
Inj Gancyclovir 150 BD IV Prophylaxis 10-11-2016 11-11-2016
Inj Falcigo 40 mg OD IV Anti-malarial 10-11-2016 10-11-2016
Syp Duphalac 15 ml HS PO Laxative 23-11-2016 27-11-2016
Tab Ranitidine 150 mg BD PO Acidity 23-11-2016 Yes
Inj Tramadol 30 mg Stat IV Pain 28-11-2016 28-11-2016
Inj Megnex forte 3 mg BD IV Fever 28-11-2016 04-12-2016
Inj Amikacin 300 mg BD IV Fever 28-11-2016 04-12-2016
13
Inj Clidamycin 450 mg TDS IV Antibiotic 28-11-2016 04-12-2016
Tab Chymoral forte 50 mg TDS PO Inflammation 28-11-2016 08-12-2016
Inj Tramadol 45 mg TDS IV Pain 29-11-2016 02-12-2016
Cap Clindamycin 450 mg TDS PO Antibiotic 05-12-2016 08-12-2016
Inj Megnex forte 1.5 mg TDS IV Antibiotic 05-12-2016 09-12-2016
14
Syp Duphalac 20 ml TID PO Constipation 04-12-2016 09-12-2016
Tab Allopurinol 100 mg TDS PO Hyperuricemia 04-12-2016 07-12-2016
Syp Digene 5 ml TDS PO Acidity 04-12-2016 07-12-2016


drug g
Tab Foseal 400 mg OD PO Hyperphospharemia 04-12-2016 07-12-2016
Tab Vorizol 200 mg BD PO Fungal prophylaxis 04-12-2016 05-01-2017
Tab Acivir 200 mg BD PO Viral prophylaxis 04-12-2016 05-01-2017
Tab Amlong 2.5 mg BD PO Hypertension 29-11-2016 Yes
Inj Megnex forte 2 gm BD IV Antibiotic 27-12-2016 31-12-2016
Inj PCM 220 mg SoS IV Antipyretic 29-12-2016 07-01-2017
Syp Grilinctus 5 ml TDS PO Cough 27-12-2016 29-12-2016
Inj Ondem 4 gm TDS IV Vomiting 29-12-2016 04-01-2017
Inj Telicoplanin 200 mg Stat IV Antibiotic 30-12-2016 30-12-2016
Tab Zyloric 100 mg TDS PO Hyperuricemia 14-12-2016 16-12-2016
Tab Foseal 400 mg TDS PO Hyperphospharemia 14-12-2016 16-12-2016
Inj Ondem 4 gm Stat Iv stat Vomiting 16-12-2016 16-12-2016
Tab Lophos 667 mg BD PO Acidity 16-12-2016 18-12-2016
15
Inj Rasburicase 1.5 mg Stat IV stat Hyperuricemia 16-12-2016 16-12-2016
Syp Digene 15 ml TDS PO Acidity 16-12-2016 21-12-2016
Tab Febuxostat 40 mg BD PO Hyperuricemia 17-12-2016 22-12-2016
Tab Septran 480 mg BD PO Antibiotic 24-12-2016 Yes
Tab Clotrimazole 10 mg TDS PO Antibiotic 22-12-2016 26-12-2016
Tab Vorizole 300 mg BD PO Anti-fungal 22-12-2016 14-01-2017


drug g
Vit D3 sachet 60,000 IU 1/week PO Dietary supplement 22-12-2016 Yes
Tab Shelcal 250 mg OD PO Calcium supplement 22-12-2016 Yes
Inj Magnex forte 3 gm OD IV Fever 25-12-2016 29-12-2016
Inj Mexopenem 1 gm TDS IV Fever 11-01-2017 22-01-2017
Tab PCM 500 mg stat Stat PO Fever 11-01-2017 11-01-2017
Inj Emeset 4 mg TDS IV Vomiting 12-01-2017 18-01-2017
Inj PCM 500 mg Stat IV Fever 12-01-2017 12-01-2017
Tab Vorizole 200 mg BD PO Fungal infection 22-01-2017 14-01-2017
Inj Vit-k 10 mg OD IV Supplement 12-01-2017 14-01-2017
Tab Vorizole 200 mg BD PO Fungal infection 17-01-2017 Yes
Tab Udiliv 300 mg BD PO Supplement 14-01-2017 Yes
Topical
Oint Metrogyl 40 mg TDS Mouth mucositis 16-01-2017 22-01-2017
(oral cavity)
Tab Monocef-) 200 mg BD PO Fever 23-01-2017 28-01-2017
Tab Levoflox 500 mg BD PO Fever 23-01-2017 28-01-2017
Syp Corex 5 ml BD PO Cough 31-12-2016 02-01-2017
Inj Magnex forte 2 gm TDS IV Fever 02-01-2017 10-01-2017


drug g
Syp Gelusil 10 ml TDS PO Acidity 02-01-2017 04-01-2017
Tab Metformin 500 mg BD PO Hyperglycemia 06-01-2017 26-01-2017
Inj Insulin 20 units Stat SC 06-01-2017 06-01-2017

Hyperglycemia
Tab Amlodopine 2.5 mg OD PO Hypertension 17-01-2017 04-02-2017
Inj Magnex forte 1.3 gm TDS IV Fever 24-01-2017 27-01-2017
Inj Pan 25 mg Stat IV Epigastric distress 24-01-2017 24-01-2017
16 Syp PCM 5 ml Stat PO Fever 25-01-2017 25-01-2017

Tab Udiliv 300 mg TDS PO Liver supplement 25-01-2017 04-02-2017
Tab Rantac 150 mg BD PO Acidity 25-01-2017 Yes
Tab Glycomet 500 mg BD PO Hyperglycemia 25-01-2017 29-01-2017
Inj Pantop 20 mg OD IV Acidity 26-01-2017 03-02-2017
Inj Ondem 4 mg TDS IV Vomiting 26-01-2017 31-01-2017
Inj PCM 30 ml SoS IV Fever 26-01-2017 04-02-2017
Cap Evion 400 mg TDS PO Hypertension 30-01-2017 04-02-2017
Cap Evion 400 mg TDS PO Hypertension 26-01-2017 29-01-2017
Vit D Sachat 600000 IU Week PO Vit Supplement 28-01-2017 Yes
Vit A Ampule 200000 IU Week PO Vit Supplement 28-01-2017 04-02-2017
Inj Tramadol 2.5 mg Stat IV Pain 26-01-2017 26-01-2017


drug g
Inj Rantac 50 mg BD IV Acidity 28-01-2017 28-01-2017
Inj Amphotericin-B 75 mg OD IV Fungal infection 29-01-2017 04-02-2017
Inj Vit-K 10 mg OD IV Coagulopathy 29-01-2017 29-01-2017
Syp A to Z 5 ml BD PO Vit supplement 29-01-2017 04-02-2017
Syp Zinconia 5 ml OD PO Zinc Supplement 29-01-2017 04-02-2017
Tab Vorizol 200 mg BD PO Fungal infection 22-12-2016 Ongoing
Onit Metrogyl gel LA 2% w/w TDS Topical Anal pain 30-01-2017 Ongoing
17 Onit Lignocaine gel
2% w/w BD Topical Anal pain 30-01-2017 Ongoing
LA
Tab Chymocip 1,00,000 EU BD PO infection 30-01-2017 Ongoing
Tab Ciplox-TZ 250 mg ½ tab BD PO Infection 30-01-2017 06-02-2017
Syp Cortex Dx 5 ml TDS PO Cough 13-01-2017 18-01-2017
Tab Clamin 375 mg TDS PO Antibiotic 13-01-2017 20-01-2017
Inj Magnex forte 3 gm BD IV Antibiotic 14-01-2017 18-01-2017
18 Inj Amikacin 500 mg OD IV Antibiotic 14-01-2017 18-01-2017
Tab Ondem 4 mg TDS PO Anti emetric 23-01-2017 23-01-2017
Inj PCM 500 mg Stat IV stat Fever 23-01-2017 23-01-2017
Inj Magnex forte 3 gm BD IV Fever 23-01-2017 24-01-2017
Inj Ondem 8 mg Stat IV Vomiting 23-01-2017 23-01-2017


drug g
Inj Pantop 30 mg Stat IV Antacid 23-01-2017 23-01-2017
4.5 MIU then 1.5
Inj Colistin TDS IV Antibiotic 24-01-2017 29-01-2017
IMU
300 mg BD then
Inj Teicoplanin BD IV Antibiotic 24-01-2017 29-01-2017
300 mg OD
Tab Amlodipine 2.5 mg OD PO Hypertension 26-01-2017 29-01-2017
Tab Envas 1.25 mg BD PO Hypertension 26-01-2017 29-01-2017
Syp Ibugesic 2.5 ml OD PO Pain 26-01-2017 29-01-2017
Tab Chymoral forte 50 mg TDS PO Swelling 27-01-2017 29-01-2017
Tab Tapentadol 50 mg TDS PO Pain 27-01-2017 29-01-2017
Tab Morphine 15 mg BID PO Pain 28-01-2017 29-01-2017
Inj Tigecycline 100 mg Stat IV Antibiotic 29-01-2017 29-01-2017
Inj Calcium glucorate 10 cc TDS IV Calcium deficiency 29-01-2017 29-01-2017
Tab Zyloric 100 mg TDS PO Hyperuricemia 18-01-2017 26-01-2017
Tab Digene 7.5 ml TDS PO Acidity 18-01-2017 23-01-2017
19 Tab Septran 480 mg BD PO Prophylaxis 18-01-2017 31-01-2017
Tab Narcogen forte 650 mg TDS PO Pain 18-01-2017 31-01-2017
Tab Cetrizine 5 mg OD PO Allergy 18-01-2017 23-01-2017
Inj PCM 375 mg SoS IV Fever 28-01-2017 28-01-2017
Inj Magnex forte 1.25 mg TDS IV Fever 27-01-2017 27-01-2017


drug g
250 mg BD then
Inj Teicoplanin BD then OD IV Antibiotic 27-01-2017 10-02-2017
250 mg OD
Syp Corex 2 tbs 10 ml TDS PO Cough 27-01-2017 01-02-2017
4 MU stat then
Inj Colistin TDS IV Antibiotic 29-01-2017 10-02-2017
1.33 MU
Fentanyl patch for 72
12.5 mcg Stat Transdermal Pain 29-01-2017 31-01-2017
hrs
Inj Tranexa 200 mg TDS IV Haemorrhage 02-02-2017 10-02-2017
Inj Acyclovir 250 mg TDS IV Viral infection 01-02-2017 02-02-2017
Inj Vit-k 5 mg OD IV Coagulation 01-02-2017 04-02-2017
Inj Gancyclovir 100 mg BD IV Viral infection 02-02-2017 04-02-2017
Syp Corex 5 ml TDS PO Cough 02-02-2017 06-02-2017
Inj Fentanyl 15 mg TDS IV Pain 04-02-2017 08-02-2017
Inj Acivir 20 mg TDS IV Infection 04-02-2017 10-02-2017
Inj Metronidazole 250 mg TDS IV Anaerobic infection 03-02-2017 10-02-2017
Inj Dexan 3 mg TDS IV Supportive care 03-02-2017 10-02-2017
Inj Lasix 10 mg SoS IV CVS support 07-02-2017
Inj Midaz 1 mg SoS IV Sedative muscle relax 08-02-2017 08-02-2017


drug g
Syp Grilinctus 7.5 ml TDS PO Cough 10-02-2017 Yes
Tab Morphine 5 mg QID PO Pain 10-02-2017 Yes
Tab Voriconazole 300 mg BD PO Anti-fungal infection 05-07-2017 09-07-2017
Inj Magnex forte 3 mg BD IV Fever 05-07-2017 Yes
Antibiotic for febrile
Inj Amikacin 800 mg OD IV 05-07-2017 Yes
neutropenia
Tab Rantac 75 mg BD OD 05-07-2017 Yes
Tab Primolet 5 mg BD PO Antibiotic 05-07-2017 11-07-2017
Tab Narcogen forte 650 mg Stat PO Pain 07-07-2017 07-07-2017
Inj
Cefoperazone+sulbac 3 gm TDS IV 16-07-2017 17-07-2017
neutropenia
20 tam
Inj Amikacin 700 mg OD IV 16-07-2017 17-07-2017
neutropenia
Inj Magnex forte 3 mg BD IV Fever 16-07-2017 18-07-2017
Inj PCM 700 mg Stat IV Fever 16-07-2017 16-07-2017
Inj Tramadol 50 mg BD IV Pain 16-07-2017 Yes
Inj Teicoplanin 400 mg BD IV 16-07-2017 17-07-2017
neutropenia
Inj Ranitidine 50 mg BD IV Acidity 16-07-2017 17-07-2017
Tab Norethisterone 5 mg TDS PO Menorrhagia 16-07-2017 11-08-2017
Tab Vitamin k 10 mg OD IV Supplement vitamin 16-07-2017 11-08-2017
Inj Tigecycline 50 mg BD IV Antibiotic infection 18-07-2017 24-07-2017


drug g
Inj Colistin 3.2 MU BD IV Antibiotic infection 18-07-2017 30-07-2017
Inj Caspofungin 50 mg BD IV Antibiotic infection 18-07-2017 26-07-2017
Inj Meropenem 2 gm TDS IV Antibiotic infection 17-07-2017 11-08-2017
Inj Pantaprazole 40 mg OD IV Anti-acidity 17-07-2017 11-08-2017
Tab Amlodipine 2.5 mg BD PO Anti-hypertension 24-07-2017 24-07-2017
Tab Nifedepine 5 mg SoS PO Anti-hypertension 24-07-2017 24-07-2017
Inj Lasilactone 10 mg Stat IV Anti-hypertension 23-07-2017 23-07-2017
Hyper tonic saline
Inj Dextrose 25 % 10 ml/hr Stat IV 20-07-2017 20-07-2017
,Hypoglycaemia
Hyper tonic saline
Inj Dextrose 25 % 10 ml/hr Stat IV 25-07-2017 25-07-2017
,Hypoglycaemia
Inj Caspofungin 50 mg BD IV Antifungal infection 09-08-2017 11-08-2017
Tab Rantac 150 mg ½ BD PO Antacid 16-07-2017 17-07-2017
Antibiotic febrile
Inj Teicoplanin 400 mg BD IV 08-08-2017 11-08-2017
neutropenia
Inj Colistin 2 MU BD IV Antibiotic infection 08-08-2017 10-08-2017
Inj Anidulafungin 100 mg OD IV Antifungal 08-08-2017 11-08-2017
Inj Gentamycin 200 mg OD IV Antibiotic 09-08-2017 11-08-2017
Inj Gancyclovir 200 mg BD IV Antiviral 07-08-2017 09-08-2017
Inj Fosformycin 1 gm TDS IV Antibiotic 09-08-2017 11-08-2017
Inj Dexamethasone 8 mg TDS IV Steroid 09-08-2017 11-08-2017
Syp Zinconia 3 ml BD PO Mineral supplement 09-08-2017 11-08-2017
Syp Calcimax 5 ml BD PO Calcium supplement 09-08-2017 11-08-2017
Inj Paracetamol 500 mg QID PO Antipyretic 09-08-2017 11-08-2017
Inj Etoposide 50 mg OD IV HLH 04-08-2017 04-08-2017


drug g
Inj Methotrexate 12 mg OD IT HLH 04-08-2017 04-08-2017
Inj Midazolam 1 mg/ml BD IV Sedation 09-08-2017 11-08-2017
Inj Fentanyl 10 mcg/cc BD IV Sedation 09-08-2017 11-08-2017
Tab wysolone 10 mg BD PO Prophylaxis 05-07-2017 26-07-2017
Tab Rantac 150 mg BD PO Prophylaxis 05-07-2017 26-07-2017
Tab Azee 500 mg OD PO Antibiotic 11-07-2017 13-07-2017
Syp Benzocaine 5 ml TDS PO Mucosistis 11-07-2017 13-07-2017
21
Tab Vorizole 200 mg BD PO Fungal Prophylaxis 11-07-2017 13-07-2017
Tab Azithromycin 250 mg OD PO Antibiotic 11-07-2017 13-07-2017
Tab Nifedepin 5 mg Stat PO Anti-hypertensive 25-07-2017 25-07-2017
Tab wysolone 10 mg BD PO Immunosuppressant 26-07-2017 28-07-2017
Tab Amlodipine 5 mg OD PO Anti-hypertensive 27-07-2017 Yes
Inj Phenytoin 900 mg Stat IV Seizures 17-07-2017 17-07-2017
Inj Levetiracetam 600 mg BD IV Seizures 17-07-2017 01-08-2017
Inj Dexamethasone 5 mg TDS IV Seizures 16-07-2017 28-07-2017
Tab Nifedepine 5 mg SoS PO Hypertension 17-07-2017 17-07-2017
Tab Amlodipine 2.5 mg OD PO Hypertension 18-07-2017 30-07-2017
22 Sedation for Artificial
Inj Niduzolam 1.5 mg Stat IV 17-07-2017 17-07-2017
ventilation
Inj Fentanyl 10 mg/hr Infusion IV drip Sedation 17-07-2017 20-07-2017
Inj Ranitidine 50 mg TDS IV Acidity 17-07-2017 18-07-2017
Inj Meropenem 2 gm BD IV Antibiotic sepsis 19-07-2017 01-08-2017
Inj Teicoplanin 400 mg OD IV Antibiotic sepsis 19-07-2017 01-08-2017


drug g
Inj Colistin 7.5 mv TDS IV Antibiotic sepsis 24-07-2017 01-08-2017
Inj Clindamycin 500 mg TDS IV Antibiotic sepsis 29-07-2017 31-07-2017
Inj Fosfomycin 4 gm TD IV Antibiotic sepsis 31-07-2017 01-08-2017
Inj Anidulafungin 100 mg OD IV Antifungal sepsis 31-07-2017 01-08-2017
Inj
10mg/hr TDS IV Antiepileptic seizures 19-07-2017 21-07-2017
Dexemedetomidine
Inj Pantaprazole 40 mg OD IV Antiacidity 19-07-2017 30-07-2017
Tab Udiliv 300 mg BD PO Increased liver enzymes 29-07-2017 30-07-2017
12mg/50 cc (30
Inj Noradrenaline Per hour IV Inotrope hypotension 31-107-2017 01-08-2017
cc/hr)
Inj Vasopressin
1.8ml/hr Per hour IV Inotrope hypotension 31-07-2017 01-08-2017
1unit/1 ml
Tab Ranitidine 75 mg BD PO Antiacidity 16-07-2017 30-07-2017
Inj Meropenem 750 mg TDS IV Empirical Antibiotic 18-08-2017 25-08-2017
Inj Amikacin 500 mg TDS IV Empirical Antibiotic 18-08-2017 22-08-2017
Inj Teicoplanin 300 mg TDS IV Empirical Antibiotic 18-08-2017 Ongoing
Inj
Cefoparazone+sulbac 3 gm Stat IV Empirical Antibiotic 18-08-2017 18-08-2017
tum
Tab Paracetamol 500 mg SoS PO Antipyretic 18-08-2017 25-08-2017
23
Tab Voriconazole 200 mg BD PO Antifungal agent 18-08-2017 23-08-2017
Tab
Sulfamethoxazolet 1mg BD PO Antibiotic 25-08-2017 26-08-2017
trimethoprim (Septra)
Tab Clotrimazole
10 mg TDS PO Antifungal agent 25-08-2017 Yes
Lozenges
Tab Ranitidine 150 mg BD PO Antacid 25-08-2017 Yes
Inj Meropenem 750 mg TDS IV Empirical Antibiotic 06-09-2017 Yes


drug g
Inj Amikacin 450 mg OD IV Empirical Antibiotic 06-09-2017 Yes
Inj Teicoplanin 360 mg TDS IV Empirical Antibiotic 06-09-2017 Yes
Tab Voriconazole 300 mg BD PO Antifungal agent 06-09-2017 Yes
Inj Colistin 1.5 MV TDS IV Antibiotic sepsis 14-09-2017 Yes
Syp Posaconazole 5 ml TDS PO Fungal Prophylaxis 15-09-2017 22-09-2017
Inj
Cefoparazone+sulbac 3 gm OD IV Antibiotic 14-09-2017 14-09-2017
tum
Tab Entecavir 5 mg BD PO Antifungal agent 15-09-2017 22-09-2017
Tab Acivir 400 mg BD PO Antifungal agent 15-09-2017 22-09-2017
Tab Meftal 250 mg SoS PO Pain 16-09-2017 17-09-2017
Inj Vitamin-k 5mg OD IV Vitamin Supplement 14-09-2017 15-09-2017
Tab Udiliv 150 mg BD PO Liver supplement 11-09-2017 Yes
Inj Granisetron 1 mg OD IV Vomiting 09-09-2017 11-09-2017
Tab A to Z Multivitamin BD PO Vitamin Supplement 15-09-2017 Yes
Inj Tranexa 250 mg TDS IV Anti-clotting 14-09-2017 Yes
Syp Duphalac 10 ml BD PO Constipation 14-09-2017 Yes
Inj Acyclovir 250 mg TDS IV Antiviral 29-09-2017 20-10-2017
Inj Fluconazole 150 mg OD IV Antifungal 29-09-2017 04-10-2017
25 Inj
Sulbactum+cefoperaz 3 mg stat BD IV Antibiotic 28-09-2017 04-10-2017
one
Inj Clindamycin 300 mg OD IV Antibiotic 28-09-2017 08-10-2017


drug g
Tab Narcogen forte 300 mg OD IV Pain killer 28-09-2017 08-10-2017
Syp Benzolaine
Magaldrate, 5 ml TDS PO Antiacidity 28-09-2017 17-10-2017
simethicone
Inj Ondem 4 mg BD IV Antiemetic 28-09-2017 04-10-2017
Tab Bromelain,
trypsin, rutoside 238 mg TDS PO Anti-inflammatory 05-10-2017 18-10-2017
trihydrate
Inj Colistin 48 mg TDS IV Antibiotic sepsis 08-10-2017 12-10-2017
Inj Meropenem 500 mg TDS IV Antibiotic sepsis 08-10-2017 17-10-2017
Inj Voriconazole 700 mg BD IV Antifungal 08-10-2017 17-10-2017
Inj Pantoprazole 20 mg BD PO Antiacidity 30-09-2017 04-10-2017
Tab Pantoprazole 20 mg BD PO Antiacidity 05-10-2017 17-10-2017
Inj Tramadol 25 mg QDS IV Painkiller 08-10-2017 14-10-2017
Tab Tramadol,
Paracetamol, 30 mg BD PO Analgesics 05-10-2017 07-10-2017
Domeperidone
Inj Tiecycline 50 mg BD IV Antibiotic 08-10-2017 17-10-2017
Tab Ranitidine HCL 75 mg BD PO Acidity 02-12-2017 08-12-2017
Tab Ondensetron 4 mg Stat PO Vomiting 02-12-2017 02-12-2017
Inj Magnex forte 1.5 gm TDS IV Antibiotic for fever 09-12-2017 11-12-2017
Inj Metrogyl 150 mg TDS IV Antibiotic for fever 09-12-2017 11-12-2017
27
Tab Metronidazole 400 mg Stat PO Fungal prophylaxis 12-12-2017 12-12-2017
Tab Monocef 100 mg Stat PO Antibacterial 12-12-2017 12-12-2017
Syp Zinc 5 ml OD PO Mineral supplement 12-12-2017 12-12-2017
Tab Ranitidine 75 mg BD PO Acidity 12-12-2017 Yes


drug g
Inj Paracetamol 230 mg Stat IV Fever 17-12-2017 17-12-2017
Inj Magnex forte 1.8 gm TDS IV Antibiotic for fever 17-12-2017 21-12-2017
Syp Paracetamol 5 ml SoS PO Fever 17-12-2017 19-12-2017
14.3.2 Listing of Deaths, Other Serious and Significant Adverse Events

There were 25 (twenty five) SAEs in 19 (nineteen) patients were reported in this study. In which 07 cases of deaths were
reported to regulatory authority. Out of 07 deaths, 05 deaths occurred during study however 02 deaths happened after
completion of the study while they were undergoing treatment as per ALL treatment protocol.
14.3.3 Narratives of Deaths, Other Serious and Certain Other Significant Adverse Events
There were 07 deaths (05 during study & 02 after completion of study) and certain other significant SAEs reported in
this study. Total of Nineteen patients had SAEs in the study and the details are as below.
Table 31: Narratives of Deaths, Other Serious and Certain Other Significant Adverse Events
Onset Resolved
Patient Study Relationship to
Adverse Event Severity Management
No Drug study drug Date Time Date Time
Febrile Neutropenia Febrile Neutropenia
1 Hamsyl grade-3 and Oral Disease related Severe grade-3 and Mucositosis 16-2-16 02:00 18-2-16 10:32
mucositosis grade-2 grade-2
Suspected fungal Suspected fungal
1 Hamsyl Not related Mild 26-2-16 10:00 17-3-16 NA
infection infection
4 Oncaspar Disease related Severe 26-3-16 07:00 11-4-16 20:27
grade-4 grade-4
Grade-I fever and Grade-I fever and
5 Oncaspar Not related Mild 7-4-16 01:00 4-5-16 Death
Cardiac arrest (Death) Cardiac arrest (Death)

Onset Resolved
Not
Diarrhea and Cardiac Diarrhea and Cardiac
6 Hamsyl related/Disease Severe 26-5-16 22:00 26-5-16 Death
arrest (Death) arrest (Death)
related
Not
Diarrhea, Vomiting and Diarrhea, Vomiting and
7 Oncaspar related/Disease Severe 3-6-16 15:45 3-6-16 Death
Septic shock (Death) Septic shock (Death)
related
8 Hamsyl Disease related Mild 11-6-16 19:00 21-6-16 NA
Grade-4 Grade-4
Febrile Neutropenia and Febrile Neutropenia and
8 Hamsyl Not related Severe 23-6-16 15:45 4-7-16 16:43
Enterocolitis Enterocolitis
9 Oncaspar (grade-4) Oral mucositis Not related Moderate (grade-4) Oral mucositis 3-11-16 00:05 1-12-16 11:34
(grade-1) (grade-1)
11 Hamsyl grade-4 and sinusitis Not related Moderate grade-4 and sinusitis 16-11-16 23:45 3-12-16 08:03
grade-3 grade-3
Febrile Neutropenia and
Febrile Neutropenia and 11-11-
12 Oncaspar Cardiac arrest (death) Not related Severe 8-11-16 19:00 Death
Cardiac arrest (death) 16
Febrile Neutropenia
13 Hamsyl Not related Moderate Febrile Neutropenia 28-11-16 16:51 5-12-16 12:13
14 Oncaspar Not related Moderate 27-11-16 21:46 5-1-17 NA
22-12-
15 Hamsyl Tumor lysis syndrome Not related Moderate Tumor lysis syndrome 16-12-16 23:30 11:43
16
Febrile Neutropenia
15 Hamsyl Febrile Neutropenia Not related Moderate 11-1-17 01:40 23-1-17 13:01
Non- Compliance of Non- Compliance of
16 Oncaspar Not related Mild 2-1-17 22:00 10-1-17 NA
medication medication
16 Oncaspar (grade-4)/ Not related Moderate (grade-4)/ 25-1-17 12:25 5-2-17 13:37
Hyperbilurubinemia Hyperbilurubinemia

Onset Resolved
(grade-5) and Multi (grade-5) and Multi
18 Hamsyl Not related Moderate 24-1-17 08:00 30-1-17 Death
organ dysfunction organ dysfunction
(Death) (Death)
19 Oncaspar Lung Infection (grade-4) Not related Moderate Lung Infection (grade-4) 27-1-17 17:20 10-2-17 13:27
13 Hamsyl Pancreatitis - (Grade -3) Possible Severe Pancreatitis - (Grade -3) 2-1-17 15:17 19-1-17 12:30
20 Hamsyl (Grade-4) Hematoma Disease related Severe (Grade-4) Hematoma 16-7-17 04:17 11-8-17 Death
(Grade-1) Death (Grade-1) Death
Hospitalization (Grade-4
Grade-4 reversible
reversible
leukoencephalopathy &
22 Hamsyl leukoencephalopathy & Disease related Moderate 17-7-17 16:37 1-8-17 Death
grade -3 HTN and
grade -3 HTN and
seizures- Death
seizures- Death
23 Hamsyl Fever grade-2 Not related Moderate Grade -2 fever 18-8-17 10:00 25-8-17 10:00
Grade -4 Febrile Grade -4 Febrile
neutropenia, Grade-3 neutropenia, Grade-3
23 Hamsyl Not related Moderate 6-9-17 11:05 20-9-17 16:31
Hypotension and Grade - Hypotension and Grade -
4 sepsis 4 sepsis
Grade -4 Febrile Grade -4 Febrile
neutropenia, Grade-4 neutropenia, Grade-4 18-10-
25 Oncaspar Not related Moderate 29-9-17 11:00 NA
Mucositis and Grade -4 Mucositis and Grade -4 17
Esophagitis esophagitis
NA= Not available


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Comparative Pharmacokinetic Study of Hamsyl® Injection 5 ml/vial

Clinical Report (Protocol No.: EM002)

14.0 TABLES, FIGURES AND GRAPHS REFERRED TO BUT NOT INCLUDED

Patient Number Age (years) Height (cms) Weight (kgs) Gender

Confidential Page 97 of 174

14.1.2 BSA details for Patient participated in the study

Confidential Page 98 of 174

14.2 Endpoint Data

1 T 0.7671 20.466 151.96 236.44 397.09 337.34 290.54 126.83

2 R 0.000 31.351 186.59 300.19 438.49 384.34 269.52 127.40

3 T 0.000 20.466 182.13 322.64 391.16 269.52 172.08 96.180

4 R 0.000 18.793 153.75 185.95 235.03 171.45 116.07 73.084

5 R 0.000 31.350 150.16 NA 461.73 NA 277.140 144.50

6 T 11.977 19.955 51.329 308.715 642.393 439.446 293.277 NA

7 R 12.802 26.628 56.392 177.218 376.240 283.994 163.352 NA

8 T 7.337 11.379 44.761 91.124 268.15 156.65 126.19 90.51

9 R 8.804 13.013 46.527 93.599 166.76 170.21 125.45 91.124

10 T 9.503 33.651 121.10 179.89 440.91 308.72 200.58 167.95

11 T 2.699 13.000 177.80 272.21 576.23 351.53 297.90 149.69

12 R 10.479 21.525 256.000 314.190 579.235 428.775 204.386 NA

13 T 13.647 21.167 134.25 294.15 532.68 354.68 300.74 179.23

14 R 11.412 16.299 46.211 239.46 428.78 296.96 270.42 131.74

15 T 11.726 62.144 250.97 364.78 484.07 350.23 294.69 102.31

16 R 0.000 44.732 153.98 206.65 617.66 444.40 341.18 91.775

17 R 0.000 38.082 268.33 482.17 580.41 414.51 346.60 188.29

18 T 0.000 24.577 298.34 425.92 481.53 215.07 117.73 83.005

Confidential Page 99 of 174

0.00 1.00 6.00 24.00 48.00 120.00 168.00 312.00

19 R 0.000 41.750 201.92 222.50 591.43 332.86 251.61 102.65

20 T 0.000 0.0000 35.235 201.92 374.78 325.59 239.17 118.39

21 R 0.000 8.2068 111.07 256.59 348.31 225.81 273.39 29.172

22 T 0.000 2.867 7.584 81.472 221.838 91.653 22.466 1.013

23 T 0.000 23.561 37.803 83.475 126.6 139.91 96.904 35.005

24 R 4.574 4.5747 167.72 NA 541.77 487.61 361.88 199.02

25 R 0.000 31.288 208.75 380.3 444.77 616.98 383.41 295.02

26 T 12.443 16.007 80.454 140.56 203.87 169.61 102.92 76.675

27 R 0.000 61.951 165.04 307.65 527.02 480.62 211.21 76.675

28 R 1.026 15.285 89.097 352.83 383.41 343.88 306.24 138.39

29 T 0.000 9.0097 183.54 386.53 517.92 346.85 161.63 75.736

Minimum 0.000 0.000 7.584 81.472 126.600 91.653 22.466 1.013

Maximum 13.647 62.144 298.340 482.170 642.393 616.980 383.410 295.020

Mean 4.110 23.554 138.579 255.893 426.906 319.257 228.230 115.052

Median 0.000 20.466 151.960 256.590 440.910 335.100 251.610 102.480

SD 5.303 15.412 78.577 107.743 141.037 122.381 92.678 60.455

CV% 129.030 65.433 56.702 42.105 33.037 38.333 40.607 52.545

NA= Not Available

Confidential Page 100 of 174

Table 14: Plasma Anti-L-asparaginase Antibodies Estimation for All

8 T 6.039 7.110 7.087

13 T -0.275 -0.896 -0.748

Confidential Page 101 of 174

27 R 8.9863 2.1468 0.61546

Confidential Page 102 of 174

8 T 43.939 2.008 3.011

13 T 26.515 1.152 1.235

Confidential Page 103 of 174

28 R 24.7 1.3 2.0

Confidential Page 104 of 174

8 T 1385.274 840.753 1654.110

13 T 919.521 1224.315 1114.726

Confidential Page 105 of 174

28 R 1215.753 928.082 912.671

Confidential Page 106 of 174

8 T 9.925 23.195 29.248