Table 3.
Additional Adverse Events by CTCAE System Categorya
| CTCAE System Category | Total Events (No.) |
# Participants (%) with
Adverse Events b |
|||
|---|---|---|---|---|---|
| GTE | Placebo | GTE (n = 538) |
Placebo (n = 537) |
P-value | |
| Surgical and Medical Procedures | 46 | 48 | 39 (7.3) | 41 (7.6) | 0.81 |
| Investigations | 67 | 14 | 44 (8.2) | 14 (2.6) | <0.001 |
| Nervous | 36 | 34 | 34 (6.3) | 33 (6.2) | 0.91 |
| Injury, Poisoning and Procedural Complications | 27 | 29 | 19 (3.5) | 22 (4.1) | 0.63 |
| Psychiatric | 22 | 11 | 17 (3.2) | 11 (2.1) | 0.25 |
| Reproductive System and Breast | 12 | 19 | 12 (2.2) | 17 (3.2) | 0.34 |
| Skin and Subcutaneous Tissue | 19 | 8 | 18 (3.4) | 8 (1.5) | 0.05 |
| Ear and Labyrinth | 10 | 10 | 9 (1.7) | 9 (1.7) | 1.00 |
| Eye | 6 | 14 | 6 (1.1) | 13 (2.4) | 0.10 |
| Renal and Urinary | 6 | 10 | 6 (1.1) | 8 (1.5) | 0.59 |
| Cardiac | 8 | 5 | 7 (1.3) | 5 (0.9) | 0.56 |
| Immune System | 7 | 2 | 7 (1.3) | 2 (0.4) | 0.18c |
| Metabolism and Nutrition | 7 | 2 | 5 (0.9) | 2 (0.4) | 0.45c |
| Neoplasms (benign, malignant and unspecified (including cysts and polyps)) |
3 | 5 | 3 (0.6) | 5 (0.9) | 0.51c |
| Endocrine | 0 | 4 | 0 (0) | 3 (0.6) | 0.12c |
| Blood and Lymphatic System | 3 | 0 | 3 (0.6) | 0 (0) | 0.25c |
| Congenital, Familial, and Genetic Disorders | 0 | 2 | 0 (0) | 1 (0.2) | 0.50c |
| Hepatobiliary (not including liver enzyme abnormalities) |
0 | 1 | 0 (0) | 1 (0.2) | 0.50c |
| Social Circumstances | 1 | 0 | 1 (0.2) | 0 (0) | 0.50c |
a
Adverse events coded using NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. AE system categories included contributed < 5% each to total number of adverse events.
b
Data presented as number of participants (% total participants). For participants who reported multiple AEs within a given system category, the most severe AE per subject, per system is presented.
c
Based on Fisher’s exact test.
Abbreviation: GTE, green tea extract.