Table 1.

Demonstrates all adverse events for both Arm I and Arm II Please note in Table 1c the investigations category can best be described as abnormal lab findings, or other abnormal procedural findings (i.e. ejection fraction decreased is categorized here as well as urine output decreased).

A. Distribution of AEs Per Patient (any grade) During Chemotherapy
Treatment Arm	Sum	Mean	Standard Deviation	Minimum	First Quartile	Median	Third Quartile	Maximum
Carboplatin/Paclitaxel only (C/P)	433	15.46	16.26	0	6.5	8.5	18	73
Carboplatin/Paclitaxel +Trastuzumab (C/P+T)	544	17.00	16.01	0	8	10.5	25.5	72
BOTH ARMS	977	16.28	16.01	0	7	10	20.5	73
B: Adverse Events (AEs) by Grade and Treatment Arm
	Number of AEs by Grade					Number of AEs, All Grades
TREATMENT ARM	1	2	3	4	5
Carboplatin/Paclitaxel only (C/P)	273	121	34	3	2	433
Carboplatin/Paclitaxel +Trastuzumab (C/P+T)	343	138	52	11	.	544
BOTH ARMS	616	259	86	14	2	977
C: Adverse Events (AEs) by Grade and System Organ Class
	Number of AEs by Grade					Number of AEs, All Grades
SYSTEM ORGAN CLASS (CATEGORY)	1	2	3	4	5
Gastrointestinal disorders	109	37	9	.	.	155
Investigations	74	44	25	4	.	147
Blood and lymphatic system disorders	38	27	17	7	.	89
General disorders and administration site conditions	65	23	.	.	.	89
Skin and subcutaneous tissue disorders	47	33	1	.	.	81
Metabolism and nutrition disorders	54	16	10	.	.	80
Musculoskeletal and connective tissue disorders	54	21	1	.	.	76
Nervous system disorders	59	8	1	.	.	68
Respiratory, thoracic and mediastinal disorders	33	10	3	1	.	47
Vascular disorders	10	8	9	.	2	29
Infections and infestations	12	11	4	2	.	29
Renal and urinary disorders	14	11	3	.	.	28
Psychiatric disorders	21	1	2	.	.	24
Reproductive system and breast disorders	7	4	.	.	.	11
Eye disorders	5	2	.	.	.	7
Ear and labyrinth disorders	5	.	.	.	.	5
Injury, poisoning and procedural complications	4	.	.	.	.	4
Immune system disorders	1	3	.	.	.	4
Cardiac disorders	4	.	.	.	.	4
ALL SYSTEM-ORGAN CLASSES	616	259	86	14	2	977