No | MedDRA code | CTCAE term | Observed grade | Placebo (n = 10) | MSC (n = 11) | ||
---|---|---|---|---|---|---|---|
N | Patient ID/time | N | Patient ID/time | ||||
Investigations | Â | Â | Â | Â | Â | Â | Â |
1 | 10001551 | Alanine aminotransferase (ALT) increased | 1 | 1 | P-11/M6 | Â | Â |
2 | 10001675 | Alkaline phosphatase (ALP) increased | 1 | 4 | P-3/M6 P-8/M6, 12 P-9/M12 | 5 | P-2/M6, 9, 12 P-6/M6 P-10/M6 |
3 | 10003481 | Aspartate aminotransferase (AST) increased | 1 | 2 | P-9/M12 P-11/M6 | Â | Â |
4 | 10025258 | Lymphocyte count increased | 2 | Â | Â | 1 | P-2/M12 |
5 | 10047900 | Weight loss | 1 | 1 | P-18/M6 | Â | Â |
General disorders and administration site conditions | Â | Â | Â | Â | Â | Â | Â |
6 | 10016558 | Fever | 1 | 1 | P-18/M1 | Â | Â |
7 | 10022095 | Injection site reaction | 1 | 1 | P-3/M1 | 1 | P-6/W1 |
 |  |  | 2 | 1 | P-5/M1 | 1 | P-6/M1 |
8 | 10033371 | Pain (epigastric region) | 1 | 1 | P-12/M3 | 1 | P-13/M2 |
Metabolism and nutrition disorders | Â | Â | Â | Â | Â | Â | Â |
9 | 10020587 | Hypercalcemia | 1 | 1 | P-7/M12 | Â | Â |
10 | 10020647 | Hyperkalemia | 4 | Â | Â | 1 | P-4/M12 |
11 | 10020907 | Hyperuricemia | 1 | 1 | P-18/M12 | Â | Â |
12 | 10020949 | Hypocalcemia | 2 | 1 | P-12/M12 | Â | Â |
14 | 10021018 | Hypokalemia | 1 | 1 | P-14/M6 | Â | Â |
15 | 10021038 | Hyponatremia | 1 | 2 | P-3/M12 P-9/M12 | Â | Â |
Skin and subcutaneous tissue disorder | Â | Â | Â | Â | Â | Â | Â |
16 | 10046735 | Urticaria | 3 | Â | Â | 1 | P-1/First Injection |
Endocrine | Â | Â | Â | Â | Â | Â | Â |
17 | 10021114 | Hypothyroidism | 1 | 1 | P-8/M9 | Â | Â |
Neurology | Â | Â | Â | Â | Â | Â | Â |
18 | 10037175 | Psychiatric disorders | 1 | 1 | P-8/M6 | Â | Â |