Trial Outcomes & Findings for Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer (NCT NCT00063999)

NCT ID: NCT00063999

Last Updated: 2021-10-19

Results Overview

The time alive in months from study entry to last contact or death.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1381 participants
• Primary outcome timeframe: Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually after for a maximum of 10 years.
• Results posted on: 2021-10-19

Participant Flow

GOG 0209 accrued 1381 patients from August 2003 to April 2009. 1312 of these patients were eligible.

Participant milestones

Measure	Doxorubicin, Cisplatin, Paclitaxel Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Paclitaxel, Carboplatin Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	692	689
Overall Study COMPLETED	647	665
Overall Study NOT COMPLETED	45	24

Reasons for withdrawal

Measure	Doxorubicin, Cisplatin, Paclitaxel Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Paclitaxel, Carboplatin Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Overall Study Withdrawal by Subject	1	0
Overall Study Ineligible	44	24

Baseline Characteristics

Doxorubicin Hydrochloride, Cisplatin, and Paclitaxel or Carboplatin and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer

Baseline characteristics by cohort

Measure	Arm I (Doxorubicin Hydrochloride, Cisplatin, Paclitaxel) n=647 Participants Patients receive doxorubicin hydrochloride IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Arm II (Paclitaxel, Carboplatin) n=665 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Total n=1312 Participants Total of all reporting groups
Age, Customized <40 years	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Age, Customized 40 -49 years	67 Participants n=5 Participants	70 Participants n=7 Participants	137 Participants n=5 Participants
Age, Customized 50-59 years	192 Participants n=5 Participants	219 Participants n=7 Participants	411 Participants n=5 Participants
Age, Customized 60-60 years	256 Participants n=5 Participants	244 Participants n=7 Participants	500 Participants n=5 Participants
Age, Customized >=70 years	113 Participants n=5 Participants	114 Participants n=7 Participants	227 Participants n=5 Participants
Sex: Female, Male Female	647 Participants n=5 Participants	665 Participants n=7 Participants	1312 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually after for a maximum of 10 years.

Population: Eligible and treated patients. Data are reported from the second interim analysis.

The time alive in months from study entry to last contact or death.

Outcome measures

Measure	Arm I (Doxorubicin, Cisplatin, Paclitaxel) n=647 Participants Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Arm II (Paclitaxel, Carboplatin) n=665 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Progesterone Receptor Positive Patients with progesterone receptor positive tumors	Progesterone Receptor Negative Patients with progesterone receptor negative tumors
Number of Participants Alive at Time of Last Follow-up. Alive	376 Participants	385 Participants	—	—
Number of Participants Alive at Time of Last Follow-up. Dead	271 Participants	280 Participants	—	—

SECONDARY outcome

Timeframe: Baseline, 6 weeks post treatment start, 15 weeks post treatment start and 26 weeks post treatment start

Population: Eligible and evaluable and enrolled prior to 3/26/2006

The FACT/GOG-Ntx subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5-point Likert scale (0=not at all; 1= a little bit; 2=somewhat; 3=quite a bit; 4=very much). For east item, reversal was performed prior to score calculation so that a large score suggests less symptom. according to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges 0-16 with a large subscale score suggests less symptom or better QOL (Quality of Life).

Outcome measures

Measure	Arm I (Doxorubicin, Cisplatin, Paclitaxel) n=228 Participants Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Arm II (Paclitaxel, Carboplatin) n=246 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Progesterone Receptor Positive Patients with progesterone receptor positive tumors	Progesterone Receptor Negative Patients with progesterone receptor negative tumors
Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short) Baseline	14.9 units on a scale Standard Error 0.15	14.9 units on a scale Standard Error 0.14	—	—
Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short) 6 Weeks	13.5 units on a scale Standard Error 0.28	11.3 units on a scale Standard Error 0.27	—	—
Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short) 15 Weeks	11.1 units on a scale Standard Error 0.37	11.2 units on a scale Standard Error 0.34	—	—
Patient-reported Neurotoxicity (Ntx) as Measured by the FACT/GOG-Ntx Subscale (Short) 26 Weeks	9.5 units on a scale Standard Error 0.41	10.9 units on a scale Standard Error 0.36	—	—

SECONDARY outcome

Timeframe: Pre-treatment, 6 weeks post starting treatment (prior to cycle 3), 15 weeks post starting treatment (prior to cycle 6), 26 weeks post starting treatment

Population: Eligible and evaluable and enrolled prior to 3/26/2006

The FACT-G contains 4 subscales: Physical Well Being (7 items), Social Well Being (7 items), Emotional Well Being (6 items), Functional Well Being (7 items). The combination (14 items) of the physical well-being (PWB) and functional well-being (FWB) subscales was used to measure the HRQOL (Health Related Quality of Life). Each item is scored using a 5-point Likert scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). for each negative item, reversal was performed prior to score calculation so that a large score suggests better QOL. A subscale score was calculated as the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answred item scores by the number of items in the subscale. The QOL was measured with the summation of the PWB and FWBsubscale score and ranges 0-56 with a large score suggests better QOL.

Outcome measures

Measure	Arm I (Doxorubicin, Cisplatin, Paclitaxel) n=228 Participants Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Arm II (Paclitaxel, Carboplatin) n=246 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Progesterone Receptor Positive Patients with progesterone receptor positive tumors	Progesterone Receptor Negative Patients with progesterone receptor negative tumors
Patient Reported Quality of Life as Measured With the Combination of Physical Well-being (PWB) Subscale and Functional Well-being (FWB) Subscale From the FACT-G Baseline	39.4 units on a scale Standard Error 0.72	37.9 units on a scale Standard Error 0.7	—	—
Patient Reported Quality of Life as Measured With the Combination of Physical Well-being (PWB) Subscale and Functional Well-being (FWB) Subscale From the FACT-G 6 weeks	35.5 units on a scale Standard Error 0.73	37.5 units on a scale Standard Error 0.68	—	—
Patient Reported Quality of Life as Measured With the Combination of Physical Well-being (PWB) Subscale and Functional Well-being (FWB) Subscale From the FACT-G 15 weeks	35.3 units on a scale Standard Error 0.74	36.5 units on a scale Standard Error 0.7	—	—
Patient Reported Quality of Life as Measured With the Combination of Physical Well-being (PWB) Subscale and Functional Well-being (FWB) Subscale From the FACT-G 26 weeks	39.8 units on a scale Standard Error 0.8	38.5 units on a scale Standard Error 0.81	—	—

SECONDARY outcome

Timeframe: Patients were assessed during treatment. Following completion of treatment, follow up was assessed every 3 months for 2 years, then every 6 months for 3 years and annually thereafter, for a maximum of 10 years.

Population: Eligible patients with estrogen and progesterone receptor data.

The time alive in months from study entry to last contact or death.

Outcome measures

Measure	Arm I (Doxorubicin, Cisplatin, Paclitaxel) n=919 Participants Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Arm II (Paclitaxel, Carboplatin) n=355 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Progesterone Receptor Positive n=832 Participants Patients with progesterone receptor positive tumors	Progesterone Receptor Negative n=440 Participants Patients with progesterone receptor negative tumors
Number of Participants Alive at Time of Last Follow-up by Estrogen or Progesterone Receptor Status (Positive or Negative) Alive	408 Participants	90 Participants	380 Participants	117 Participants
Number of Participants Alive at Time of Last Follow-up by Estrogen or Progesterone Receptor Status (Positive or Negative) Dead	511 Participants	265 Participants	452 Participants	323 Participants

SECONDARY outcome

Timeframe: Assessed throughout the treatment period and for 30 days after discontinuation of treatment.

Population: Eligible and treated patients

Maximum grade of physician assessed neurotoxicity and infection

Outcome measures

Measure	Arm I (Doxorubicin, Cisplatin, Paclitaxel) n=640 Participants Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Arm II (Paclitaxel, Carboplatin) n=664 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Progesterone Receptor Positive Patients with progesterone receptor positive tumors	Progesterone Receptor Negative Patients with progesterone receptor negative tumors
Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection Grade < 2 Sensory neuropathy	167 Participants	130 Participants	—	—
Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection Grade 2 or Higher Sensory Neuropathy	473 Participants	534 Participants	—	—
Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection Grade <3 infection with Neutrope	25 Participants	29 Participants	—	—
Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection Grade 3 or Higher Infection with Neutropenia	615 Participants	635 Participants	—	—
Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection Grade <3 infection without Neutropenia	22 Participants	13 Participants	—	—
Number of Participants With Indicated Severity of CTCAE v2 Graded Neurotoxicity and Infection Grade 3 or Higher Infection without Neutropenia	618 Participants	651 Participants	—	—

Adverse Events

Arm I (Doxorubicin, Cisplatin, Paclitaxel)

Serious events: 217 serious events

Other events: 631 other events

Deaths: 271 deaths

Arm II (Paclitaxel, Carboplatin)

Serious events: 156 serious events

Other events: 657 other events

Deaths: 280 deaths

Serious adverse events

Measure	Arm I (Doxorubicin, Cisplatin, Paclitaxel) n=647 participants at risk Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Arm II (Paclitaxel, Carboplatin) n=665 participants at risk Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Immune system disorders Allergic Reaction/Hypersensitivity	0.62% 4/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.45% 3/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Blood and lymphatic system disorders Hemoglobin	0.77% 5/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	1.5% 10/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Blood and lymphatic system disorders Hematologic-Other	0.00% 0/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Blood and lymphatic system disorders Transfusion: Platelets	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Blood and lymphatic system disorders Transfusion: Prbcs	0.31% 2/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Blood and lymphatic system disorders Platelets	0.62% 4/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.75% 5/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Blood and lymphatic system disorders Neutrophils/Granulocytes	2.5% 16/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	3.9% 26/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Blood and lymphatic system disorders Leukocytes	0.77% 5/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Cardiac disorders Hypertension	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Cardiac disorders Circulatory Or Cardiac-Other	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Cardiac disorders Cardiac Left Ventricular Function	0.31% 2/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Cardiac disorders Hypotension	0.00% 0/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.30% 2/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Cardiac disorders Sinus Tachycardia	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Cardiac disorders Phlebitis	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Cardiac disorders Vasovagal Episode	0.00% 0/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Cardiac disorders Supraventricular Arrhythmias	0.31% 2/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Cardiac disorders Thrombosis/Embolism	5.1% 33/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	2.4% 16/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Cardiac disorders Cardiac-Ischemia/Infarction	0.46% 3/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Cardiac disorders Sinus Bradycardia	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Vascular disorders Prothrombin Time	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
General disorders Constitutional Symptoms-Other	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
General disorders Fever In The Absence Of Neutropenia	0.31% 2/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
General disorders Fatigue	0.77% 5/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Skin and subcutaneous tissue disorders Wound-Infectious	0.31% 2/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.45% 3/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Skin and subcutaneous tissue disorders Skin-Other	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Skin and subcutaneous tissue disorders Wound-Non-Infectious	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Gastrointestinal disorders Stomatitis/Pharyngitis	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Gastrointestinal disorders Gi-Other	0.77% 5/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.45% 3/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Gastrointestinal disorders Fistula-Intestinal	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Gastrointestinal disorders Duodenal Ulcer	0.00% 0/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Gastrointestinal disorders Ileus	0.46% 3/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.45% 3/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Gastrointestinal disorders Gastritis	0.00% 0/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Gastrointestinal disorders Mucositis Due To Radiation	0.00% 0/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Gastrointestinal disorders Colitis	0.00% 0/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.30% 2/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Gastrointestinal disorders Fistula-Rectal/Anal	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Gastrointestinal disorders Dehydration	2.5% 16/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	1.4% 9/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Gastrointestinal disorders Constipation	0.31% 2/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.60% 4/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Gastrointestinal disorders Diarrhea (Without Colostomy)	1.4% 9/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Gastrointestinal disorders Vomiting	2.0% 13/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.30% 2/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Gastrointestinal disorders Nausea	1.1% 7/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.45% 3/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Vascular disorders Melena/Gi Bleeding	0.46% 3/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Vascular disorders Vaginal Bleeding	0.31% 2/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Vascular disorders Rectal Bleeding/Hematochezia	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Vascular disorders Hemorrhage/Bleeding Without Grade 3 Or 4	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Hepatobiliary disorders Hepatic-Other	0.00% 0/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Hepatobiliary disorders Sgot	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Infections and infestations Infection, Other	0.46% 3/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Infections and infestations Catheter-Related Infection	0.93% 6/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Infections and infestations Infection With Unknown Anc	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Infections and infestations Infection Documented W Grd 3/4 Neutropn.	2.8% 18/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	1.4% 9/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Infections and infestations Infection Without Neutropenia	2.6% 17/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	1.2% 8/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Infections and infestations Febrile Neutropenia-Fuo Infect Not Docum	2.2% 14/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	2.1% 14/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Blood and lymphatic system disorders Lymphatics-Other	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Metabolism and nutrition disorders Hyponatremia	0.46% 3/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Metabolism and nutrition disorders Hypocalcemia	0.31% 2/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Metabolism and nutrition disorders Hyperglycemia	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.30% 2/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Metabolism and nutrition disorders Hypokalemia	0.77% 5/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.30% 2/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Metabolism and nutrition disorders Hypomagnesmia	0.62% 4/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Musculoskeletal and connective tissue disorders Muscle Weakness Not Due To Neuropathy	0.46% 3/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Nervous system disorders Tremor	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Nervous system disorders Neurologic-Other	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.30% 2/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Nervous system disorders Seizure(S)	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Nervous system disorders Depressed Level Of Consciousness	0.00% 0/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Nervous system disorders Cns Cerebrovascular Ischemia	0.46% 3/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Nervous system disorders Confusion	0.00% 0/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Nervous system disorders Ataxia	0.00% 0/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.30% 2/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Nervous system disorders Syncope	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Nervous system disorders Mood Alteration-Anxiety Agitation	0.00% 0/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Nervous system disorders Mood Alteration-Depression	0.46% 3/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Nervous system disorders Neuropathy-Sensory	0.31% 2/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Nervous system disorders Neuropathy Motor	0.00% 0/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.30% 2/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Eye disorders Ocular-Other	0.00% 0/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
General disorders Chest Pain Non-Cardiac Or Non-Pleuritic	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.60% 4/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
General disorders Rectal Or Perirectal Pain	0.00% 0/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
General disorders Abdominal Pain Or Cramping	0.93% 6/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.60% 4/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
General disorders Pain-Other	0.00% 0/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Respiratory, thoracic and mediastinal disorders Pneumonitis/Pulmonary Infiltrates	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Respiratory, thoracic and mediastinal disorders Pleural Effusion (Non-Malignant)	0.00% 0/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.46% 3/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.60% 4/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Respiratory, thoracic and mediastinal disorders Pulmonary-Other	0.46% 3/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Respiratory, thoracic and mediastinal disorders Adult Respiratory Distress Syndrome	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Renal and urinary disorders Ureteral Obstruction	0.00% 0/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.45% 3/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Renal and urinary disorders Fistula Or Gu Fistula	0.00% 0/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Renal and urinary disorders Renal Failure	0.00% 0/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Renal and urinary disorders Creatinine	0.62% 4/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.30% 2/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Renal and urinary disorders Renal/Gu-Other	0.31% 2/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
General disorders Syndromes-Other	0.00% 0/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.15% 1/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.

Other adverse events

Measure	Arm I (Doxorubicin, Cisplatin, Paclitaxel) n=647 participants at risk Patients receive doxorubicin IV over approximately 15-30 minutes on day 1, cisplatin IV over 60-90 minutes on day 1, paclitaxel IV over 3 hours on day 2, and filgrastim SC on days 3-12 or pegfilgrastim SC on day 3. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.	Arm II (Paclitaxel, Carboplatin) n=665 participants at risk Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Leukocytes	64.6% 418/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	83.6% 556/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Blood and lymphatic system disorders Neutrophils/Granulocytes	62.1% 402/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	88.7% 590/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Blood and lymphatic system disorders Platelets	37.7% 244/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	25.9% 172/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Blood and lymphatic system disorders Hemoglobin	68.8% 445/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	61.7% 410/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Blood and lymphatic system disorders Hematologic-Other	31.2% 202/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	23.5% 156/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Immune system disorders Allergic Reaction/Hypersensitivity	2.8% 18/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	4.4% 29/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Ear and labyrinth disorders Ear and labyrinth disorders	4.0% 26/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	2.0% 13/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Cardiac disorders Cardiac Left Ventricular Function	7.7% 50/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.00% 0/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Cardiac disorders Cardiac disorders	8.5% 55/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	6.0% 40/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Vascular disorders Vascular disorders	0.93% 6/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	1.1% 7/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
General disorders Constitutional	5.7% 37/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	3.9% 26/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	73.1% 473/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	73.1% 486/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	3.9% 25/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	1.8% 12/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Endocrine disorders Endocrine disorders	1.7% 11/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	1.1% 7/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Gastrointestinal disorders All other GI	25.2% 163/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	18.8% 125/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Gastrointestinal disorders Nausea	33.7% 218/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	18.3% 122/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Gastrointestinal disorders Vomiting	25.5% 165/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	12.3% 82/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Gastrointestinal disorders Stomatitis/Pharyngitis	8.3% 54/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	2.6% 17/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Renal and urinary disorders Renal and urinary disorders	2.3% 15/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	3.0% 20/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Hepatobiliary disorders Hepatobiliary disorders	2.6% 17/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	2.6% 17/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Infections and infestations Infections and infestations	2.9% 19/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	1.2% 8/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Infections and infestations Febrile Neutropenia-Fuo Infect Not Docum	7.0% 45/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	5.6% 37/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Infections and infestations Infection Without Neutropenia	8.3% 54/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	3.8% 25/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Blood and lymphatic system disorders Blood and lymphatic system disorders	1.1% 7/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.45% 3/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Metabolism and nutrition disorders Metabolism and nutrition disorders	21.6% 140/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	14.4% 96/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	3.7% 24/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	3.0% 20/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Nervous system disorders Nervous system disorders	10.4% 67/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	7.1% 47/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Nervous system disorders Neuropathy: sensory	25.2% 163/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	19.2% 128/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Eye disorders Eye disorders	7.1% 46/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	5.1% 34/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
General disorders Pain	14.1% 91/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	13.4% 89/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
General disorders myalgia	14.7% 95/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	14.6% 97/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	13.9% 90/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	12.3% 82/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (including cysts and polyps)	0.15% 1/647 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.	0.45% 3/665 • Adverse Events were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment, up to 10 years. CTCAE v2.0 was used to grade and categorize all AEs and SAEs until 3/31/2010. Beginning 4/1/2010 CTCAE v4 was used to grade and categorize SAEs through AdEERs. All AEs and SAEs reported here were mapped to CTCAE v2.0.

Additional Information

Linda Gedeon for Virginia Filiaci, PhD.

NRG Oncology

Phone: 716-545-8321

Email: lgedeon@gogstats.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60