Trial Outcomes & Findings for Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer (NCT NCT01091454)

NCT ID: NCT01091454

Last Updated: 2018-05-08

Results Overview

A patient is considered to be a 3-month progression-free survivor if the patient is on study treatment 3 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients and 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. If some patients are lost to follow-up not having been observed for at least 3 months, an estimate and confidence interval for the 3-month PFS rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 48 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2018-05-08

Participant Flow

Participant milestones

Measure	Treatment (Cisplatin and Brostallicin) Patients receive 50 mg/m\^2 cisplatin IV over 2 hours on day 1 and 10 mg/m\^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	48
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Treatment (Cisplatin and Brostallicin) Patients receive 50 mg/m\^2 cisplatin IV over 2 hours on day 1 and 10 mg/m\^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Study Ineligible	1

Baseline Characteristics

Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer

Baseline characteristics by cohort

Measure	Treatment (Cisplatin and Brostallicin) n=47 Participants Patients receive 50 mg/m\^2 cisplatin IV over 2 hours on day 1 and 10 mg/m\^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Age, Continuous	57 years n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

A patient is considered to be a 3-month progression-free survivor if the patient is on study treatment 3 months from registration without a documentation of disease progression. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients and 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. If some patients are lost to follow-up not having been observed for at least 3 months, an estimate and confidence interval for the 3-month PFS rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Measure	Treatment (Cisplatin and Brostallicin) n=47 Participants Patients receive 50 mg/m\^2 cisplatin IV over 2 hours on day 1 and 10 mg/m\^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
3-month Progression-free Survival (3-mo PFS) Rate	0.511 proportion of participants Interval 0.386 to 0.676

SECONDARY outcome

Timeframe: Up to 5 years

Population: Out of the total number of participants who completed the study and were evaluable for the primary endpoint and adverse events (as provided in the Participant Flow), only a subset of participants (Overall Number of Participants Analyzed specified above) were evaluable for the Confirmed Response Rate.

A confirmed response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. The confirmed response rate will be estimated by the number of confirmed responses in evaluable patients with measurable disease divided by the total number of evaluable patients with measurable disease. The appropriate confidence interval will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <1 cm.; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Measure	Treatment (Cisplatin and Brostallicin) n=45 Participants Patients receive 50 mg/m\^2 cisplatin IV over 2 hours on day 1 and 10 mg/m\^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Confirmed Response Rate	22 percentage of confirmed responses Interval 11.0 to 37.0

SECONDARY outcome

Timeframe: Up to 5 years

Duration of response is defined for all evaluable patients with measurable disease who have achieved a confirmed response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented. If a patient dies subsequent to the confirmed response without a documentation of disease progression, the patient will be considered to have had disease progression at the time of their death. The distribution of duration of response will be estimated using the method of Kaplan-Meier. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <1 cm.; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Measure	Treatment (Cisplatin and Brostallicin) n=47 Participants Patients receive 50 mg/m\^2 cisplatin IV over 2 hours on day 1 and 10 mg/m\^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Duration of Response	4 months Interval 2.6 to 14.5

SECONDARY outcome

Timeframe: At 6 months

6-month progression-free survival. A patient is considered to be a 6-month progression-free survivor if the patient is on study treatment 6 months from registration without a documentation of disease progression. The 6-month progression-free survival rate incorporating censoring will be computed using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Measure	Treatment (Cisplatin and Brostallicin) n=47 Participants Patients receive 50 mg/m\^2 cisplatin IV over 2 hours on day 1 and 10 mg/m\^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
6-month Progression-free Survival (6-mo PFS) Rate	0.277 proportion of participants Interval 0.174 to 0.439

SECONDARY outcome

Timeframe: up to 5 years

Time to disease progression is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. The distribution of time to progression will be estimated using the method of Kaplan-Meier. Progression is defined using the revised RECIST guideline (v1.1) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Measure	Treatment (Cisplatin and Brostallicin) n=47 Participants Patients receive 50 mg/m\^2 cisplatin IV over 2 hours on day 1 and 10 mg/m\^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Time to Disease Progression	3.2 months Interval 2.2 to 4.2

SECONDARY outcome

Timeframe: Up to 5 years

Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.

Outcome measures

Measure	Treatment (Cisplatin and Brostallicin) n=47 Participants Patients receive 50 mg/m\^2 cisplatin IV over 2 hours on day 1 and 10 mg/m\^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Survival Time	8.3 months Interval 4.7 to 14.9

Adverse Events

Treatment (Cisplatin and Brostallicin)

Serious events: 29 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Cisplatin and Brostallicin) n=48 participants at risk Patients receive 50 mg/m\^2 cisplatin IV over 2 hours on day 1 and 10 mg/m\^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	8.3% 4/48 • Number of events 4 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Blood and lymphatic system disorders Febrile neutropenia	14.6% 7/48 • Number of events 7 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Cardiac disorders Atrial fibrillation	2.1% 1/48 • Number of events 2 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Cardiac disorders Pericardial effusion	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Cardiac disorders Sinus bradycardia	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Gastrointestinal disorders Nausea	4.2% 2/48 • Number of events 2 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Gastrointestinal disorders Vomiting	4.2% 2/48 • Number of events 2 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
General disorders Death NOS	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
General disorders Fatigue	6.2% 3/48 • Number of events 5 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Immune system disorders Allergic reaction	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Infections and infestations Lung infection	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Infections and infestations Mucosal infection	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Infections and infestations Sepsis	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Infections and infestations Urinary tract infection	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Investigations Creatinine increased	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Investigations Neutrophil count decreased	39.6% 19/48 • Number of events 19 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Investigations Platelet count decreased	41.7% 20/48 • Number of events 24 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Investigations White blood cell decreased	10.4% 5/48 • Number of events 5 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Metabolism and nutrition disorders Hyponatremia	2.1% 1/48 • Number of events 2 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Nervous system disorders Seizure	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Nervous system disorders Syncope	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.2% 2/48 • Number of events 2 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.

Other adverse events

Measure	Treatment (Cisplatin and Brostallicin) n=48 participants at risk Patients receive 50 mg/m\^2 cisplatin IV over 2 hours on day 1 and 10 mg/m\^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	72.9% 35/48 • Number of events 146 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	2.1% 1/48 • Number of events 2 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Blood and lymphatic system disorders Febrile neutropenia	6.2% 3/48 • Number of events 4 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Cardiac disorders Atrial fibrillation	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Cardiac disorders Chest pain - cardiac	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Cardiac disorders Palpitations	4.2% 2/48 • Number of events 2 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Cardiac disorders Pericardial effusion	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Cardiac disorders Sinus tachycardia	8.3% 4/48 • Number of events 6 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Ear and labyrinth disorders Hearing impaired	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Ear and labyrinth disorders Tinnitus	8.3% 4/48 • Number of events 5 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Eye disorders Eye disorders - Other, specify	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Eye disorders Watering eyes	2.1% 1/48 • Number of events 2 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Gastrointestinal disorders Abdominal pain	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Gastrointestinal disorders Anal pain	2.1% 1/48 • Number of events 2 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Gastrointestinal disorders Constipation	25.0% 12/48 • Number of events 23 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Gastrointestinal disorders Diarrhea	35.4% 17/48 • Number of events 32 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Gastrointestinal disorders Dyspepsia	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Gastrointestinal disorders Gastroesophageal reflux disease	2.1% 1/48 • Number of events 2 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Gastrointestinal disorders Mucositis oral	16.7% 8/48 • Number of events 8 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Gastrointestinal disorders Nausea	62.5% 30/48 • Number of events 80 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Gastrointestinal disorders Oral pain	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Gastrointestinal disorders Rectal hemorrhage	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Gastrointestinal disorders Vomiting	22.9% 11/48 • Number of events 22 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
General disorders Chills	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
General disorders Edema limbs	6.2% 3/48 • Number of events 7 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
General disorders Fatigue	93.8% 45/48 • Number of events 189 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
General disorders Fever	6.2% 3/48 • Number of events 3 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
General disorders Gait disturbance	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
General disorders General disorders and administration site conditions - Other, specify	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
General disorders Infusion related reaction	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
General disorders Localized edema	4.2% 2/48 • Number of events 2 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
General disorders Malaise	4.2% 2/48 • Number of events 2 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
General disorders Non-cardiac chest pain	6.2% 3/48 • Number of events 4 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
General disorders Pain	6.2% 3/48 • Number of events 6 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Immune system disorders Allergic reaction	12.5% 6/48 • Number of events 8 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Infections and infestations Lung infection	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Infections and infestations Lymph gland infection	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Infections and infestations Mucosal infection	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Infections and infestations Skin infection	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Infections and infestations Urinary tract infection	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Infections and infestations Vaginal infection	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Injury, poisoning and procedural complications Bruising	4.2% 2/48 • Number of events 5 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Injury, poisoning and procedural complications Fall	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Investigations Alanine aminotransferase increased	14.6% 7/48 • Number of events 10 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Investigations Alkaline phosphatase increased	47.9% 23/48 • Number of events 66 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Investigations Aspartate aminotransferase increased	18.8% 9/48 • Number of events 15 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Investigations Blood bilirubin increased	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Investigations Creatinine increased	20.8% 10/48 • Number of events 26 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Investigations GGT increased	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Investigations Hemoglobin increased	4.2% 2/48 • Number of events 5 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Investigations Lymphocyte count decreased	16.7% 8/48 • Number of events 24 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Investigations Neutrophil count decreased	47.9% 23/48 • Number of events 43 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Investigations Platelet count decreased	75.0% 36/48 • Number of events 105 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Investigations Weight gain	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Investigations Weight loss	4.2% 2/48 • Number of events 5 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Investigations White blood cell decreased	33.3% 16/48 • Number of events 27 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Metabolism and nutrition disorders Anorexia	12.5% 6/48 • Number of events 16 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Metabolism and nutrition disorders Dehydration	8.3% 4/48 • Number of events 4 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Metabolism and nutrition disorders Hyperglycemia	8.3% 4/48 • Number of events 11 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Metabolism and nutrition disorders Hyperkalemia	6.2% 3/48 • Number of events 8 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Metabolism and nutrition disorders Hypermagnesemia	4.2% 2/48 • Number of events 2 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Metabolism and nutrition disorders Hypernatremia	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Metabolism and nutrition disorders Hypoalbuminemia	10.4% 5/48 • Number of events 8 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Metabolism and nutrition disorders Hypocalcemia	16.7% 8/48 • Number of events 14 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Metabolism and nutrition disorders Hypokalemia	18.8% 9/48 • Number of events 15 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Metabolism and nutrition disorders Hypomagnesemia	18.8% 9/48 • Number of events 20 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Metabolism and nutrition disorders Hyponatremia	12.5% 6/48 • Number of events 15 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Metabolism and nutrition disorders Hypophosphatemia	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Musculoskeletal and connective tissue disorders Back pain	4.2% 2/48 • Number of events 2 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Musculoskeletal and connective tissue disorders Bone pain	10.4% 5/48 • Number of events 10 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Musculoskeletal and connective tissue disorders Chest wall pain	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	4.2% 2/48 • Number of events 6 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Musculoskeletal and connective tissue disorders Myalgia	4.2% 2/48 • Number of events 2 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Musculoskeletal and connective tissue disorders Neck pain	4.2% 2/48 • Number of events 2 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Musculoskeletal and connective tissue disorders Pain in extremity	6.2% 3/48 • Number of events 5 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	4.2% 2/48 • Number of events 2 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Nervous system disorders Cognitive disturbance	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Nervous system disorders Dizziness	12.5% 6/48 • Number of events 8 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Nervous system disorders Dysgeusia	10.4% 5/48 • Number of events 12 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Nervous system disorders Headache	14.6% 7/48 • Number of events 12 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Nervous system disorders Memory impairment	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Nervous system disorders Paresthesia	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Nervous system disorders Peripheral motor neuropathy	14.6% 7/48 • Number of events 13 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Nervous system disorders Peripheral sensory neuropathy	50.0% 24/48 • Number of events 95 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Nervous system disorders Syncope	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Psychiatric disorders Anxiety	6.2% 3/48 • Number of events 3 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Psychiatric disorders Depression	2.1% 1/48 • Number of events 3 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Psychiatric disorders Insomnia	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Renal and urinary disorders Chronic kidney disease	2.1% 1/48 • Number of events 4 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Renal and urinary disorders Renal and urinary disorders - Other, specify	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Reproductive system and breast disorders Breast pain	6.2% 3/48 • Number of events 5 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Reproductive system and breast disorders Vaginal dryness	2.1% 1/48 • Number of events 3 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	4.2% 2/48 • Number of events 3 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Respiratory, thoracic and mediastinal disorders Cough	10.4% 5/48 • Number of events 6 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Respiratory, thoracic and mediastinal disorders Dyspnea	29.2% 14/48 • Number of events 33 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.2% 3/48 • Number of events 4 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Respiratory, thoracic and mediastinal disorders Hoarseness	4.2% 2/48 • Number of events 2 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	8.3% 4/48 • Number of events 4 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.1% 1/48 • Number of events 8 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Respiratory, thoracic and mediastinal disorders Productive cough	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Respiratory, thoracic and mediastinal disorders Sore throat	6.2% 3/48 • Number of events 3 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Skin and subcutaneous tissue disorders Alopecia	25.0% 12/48 • Number of events 31 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Skin and subcutaneous tissue disorders Dry skin	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Skin and subcutaneous tissue disorders Erythema multiforme	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Skin and subcutaneous tissue disorders Pruritus	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	2.1% 1/48 • Number of events 4 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Vascular disorders Flushing	4.2% 2/48 • Number of events 2 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Vascular disorders Hot flashes	2.1% 1/48 • Number of events 6 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Vascular disorders Hypertension	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Vascular disorders Hypotension	4.2% 2/48 • Number of events 3 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Vascular disorders Lymphedema	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Vascular disorders Thromboembolic event	2.1% 1/48 • Number of events 1 • Adverse events are assessed 15 days prior to registration and during the Active Monitoring Phase: once per cycle (<=3 days prior to each subsequent cycle) of treatment and at the end of treatment; for up to 5 years. This study will utilize the CTEP Active Version of NCI Common Terminology Criteria for Adverse Events (CTCAE) for adverse event monitoring and reporting (Version 4). All eligible patients that have initiated treatment will be considered evaluable for adverse event analyses. Adverse events will be graded using the NCI CTCAE coding scheme. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.

Additional Information

Alvaro Moreno-Aspitia MD

Mayo Clinic

Phone: 507-284-1159

Email: morenoaspitia.alvaro@mayo.edu

Results disclosure agreements

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