Table 2.
Adverse Events by CTCAE Categorya and Severity in GTE and Placebo Groups
| Adverse Events (No.) |
# Participants (%) with
Adverse Events b |
||||||
|---|---|---|---|---|---|---|---|
|
|
|||||||
| GTE | Placebo | Total | GTE (n=538) |
Placebo (n=537) |
P-value | ||
|
CTCAE
Category |
Infections and Infestations | 216 | 217 | 433 | 139 (25.8) | 145 (27.0) | 0.67 |
| GI Disorders | 235 | 184 | 419 | 137 (25.5) | 123 (22.9) | 0.33 | |
| Vascular Disorders | 154 | 144 | 298 | 132 (24.5) | 125 (23.3) | 0.63 | |
| Respiratory, Thoracic and Mediastinal Disorders |
122 | 122 | 244 | 83 (15.4) | 85 (15.8) | 0.86 | |
| General Disorders and Administration Site Condition |
69 | 77 | 146 | 58 (10.8) | 60 (11.2) | 0.84 | |
| Musculoskeletal and Connective Tissue Disorders |
65 | 69 | 134 | 59 (11.0) | 55 (10.2) | 0.70 | |
| Othersc | 280 | 218 | 498 | 190 (35.3) | 165 (30.7) | 0.11 | |
|
| |||||||
|
Grade
(Severity) d |
1 | 848 | 754 | 1602 | 359 (66.7) | 344 (64.0) | 0.36 |
| 2 | 279 | 268 | 547 | 172 (32.0) | 170 (31.7) | 0.91 | |
| 3 | 13 | 8 | 21 | 11 (2.0) | 7 (1.3) | 0.34 | |
| 4 | 1 | 0 | 1 | 1 (0.2) | 0 (0) | 1.00e | |
| 5 | 0 | 1 | 1 | 0 (0) | 1 (0.2) | 1.00e | |
|
| |||||||
| Totals | 1141 | 1031 | 2172 | --- | |||
Adverse events coded using NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
Data presented as number of participants (% total participants). For participants who reported multiple adverse events within a given system category, the most severe AE per subject, per system is presented.
Includes categories contributing < 5% each to total number of adverse events: surgical and medical procedures; investigations; injury, poisoning and procedural complications; neoplasms (benign, malignant and unspecified (including cysts and polyps)); social circumstances; and disorders of the following systems (in descending order of number of events): nervous; psychiatric; reproductive system and breast; skin and subcutaneous tissue; ear and labyrinth; eye; renal and urinary; cardiac; immune system; metabolism and nutrition; endocrine; blood and lymphatic system; congenital, familial and genetic; and hepatobiliary (not including liver enzyme abnormalities).
Grade: 1=mild; 2=moderate; 3=severe; 4=life-threatening; 5=death.
Based on Fisher’s exact test.
Abbreviation: GTE, green tea extract.