Table 3:

Demonstrates grade 3–5 adverse events for both Arm I and Arm II

A. Distribution of High-Grade (3–5) AEs Per Patient During Chemotherapy
Treatment Arm	Sum	Mean	Standard Deviation	Minimum	First Quartile	Median	Third Quartile	Maximum
C/P	39	1.39	2.39	0	0	0	1.5	10
C/P+T	63	1.97	3.43	0	0	0.5	3	15
Both arms	102	1.70	2.98	0	0	0	2	15
B. Number of High-Grade AEs reported
System-Organ Class	Grade 3	Grade 4	Grade 5	Sum
Gastrointestinal disorders	9	0	0	9
Investigations	25	4	0	29
Blood and lymphatic system disorders	17	7	0	24
General disorders and administration site conditions	1	0	0	1
Skin and subcutaneous tissue disorders	1	0	0	1
Metabolism and nutrition disorders	10	0	0	10
Musculoskeletal and connective tissue disorders	1	0	0	1
Nervous system disorders	1	0	0	1
Respiratory, thoracic and mediastinal disorders	3	1	0	4
Vascular disorders	9	0	2	11
Infections and infestations	4	2	0	6
Renal and urinary disorders	3	0	0	3
Psychiatric disorders	2	0	0	2
Reproductive system and breast disorders	0	0	0	0
Eye disorders	0	0	0	0
Ear and labyrinth disorders	0	0	0	0
Injury, poisoning and procedural complications	0	0	0	0
Immune system disorders	0	0	0	0
Cardiac disorders	0	0	0	0
ALL System-Organ Classes	86	14	2	102