Trial Outcomes & Findings for Phase I/II Adaptive Randomized Trial of Bevacizumab Versus Bevacizumab Plus Vorinostat in Adults With Recurrent Glioblastoma (NCT NCT01266031)

NCT ID: NCT01266031

Last Updated: 2018-07-31

Results Overview

PFS is time measured in months to disease progression as assessed at six months from participant registration. Assessments continue every 8 weeks up to 28 days after last dose (follow-up), anticipated trial length one year. Participants must be assessed at least 4 weeks after surgery to begin treatment in the adaptive randomized Phase 2 portion of the trial. PFS in participants in the surgical arm determined from the date of randomization to the treatment arms and not from the date of registration in the trial. Study outcome measure period ended June 2015.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 96 participants
• Primary outcome timeframe: Baseline until disease progression or death due to any cause, up to six months
• Results posted on: 2018-07-31

Participant Flow

Recruitment Period: the study was initially written in 2010 and eventually activated at the lead site on 7/6/2011.

Participant milestones

Measure	Vorinostat + Bevacizumab Phase I Vorinostat starting dose 400 mg orally days 1 - 7 \& days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 \& 15 of 28 day cycle.	Bevacizumab Phase II Bevacizumab 10 mg/kg/dose IV on days 1 \& 15 of a 28 day cycle.	Bevacizumab + Vorinostat 400 mg Phase II Bevacizumab 10 mg/kg/dose IV Day 1 \& 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 \& days 15 to 21 of a 28 day cycle.
Overall Study STARTED	6	41	49
Overall Study COMPLETED	6	38	47
Overall Study NOT COMPLETED	0	3	2

Reasons for withdrawal

Measure	Vorinostat + Bevacizumab Phase I Vorinostat starting dose 400 mg orally days 1 - 7 \& days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 \& 15 of 28 day cycle.	Bevacizumab Phase II Bevacizumab 10 mg/kg/dose IV on days 1 \& 15 of a 28 day cycle.	Bevacizumab + Vorinostat 400 mg Phase II Bevacizumab 10 mg/kg/dose IV Day 1 \& 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 \& days 15 to 21 of a 28 day cycle.
Overall Study Not treated	0	3	2

Baseline Characteristics

Phase I/II Adaptive Randomized Trial of Bevacizumab Versus Bevacizumab Plus Vorinostat in Adults With Recurrent Glioblastoma

Baseline characteristics by cohort

Measure	Vorinostat + Bevacizumab n=6 Participants Phase I Vorinostat starting dose 400 mg orally days 1 - 7 and days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 + 15 of 28 day cycle.	Bevacizumab n=41 Participants Phase II Bevacizumab 10 mg/kg/dose by vein on days 1 and 15 of a 28 day cycle.	Bevacizumab + Vorinostat 400 mg n=49 Participants Phase II Bevacizumab 10 mg/kg/dose IV Day 1 \& 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 \& days 15 to 21 of a 28 day cycle.	Total n=96 Participants Total of all reporting groups
Age, Continuous	51.5 years n=5 Participants	60 years n=7 Participants	57 years n=5 Participants	57 years n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants	33 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	29 Participants n=7 Participants	31 Participants n=5 Participants	63 Participants n=4 Participants
Region of Enrollment United States	6 participants n=5 Participants	41 participants n=7 Participants	49 participants n=5 Participants	96 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline until disease progression or death due to any cause, up to six months

PFS is time measured in months to disease progression as assessed at six months from participant registration. Assessments continue every 8 weeks up to 28 days after last dose (follow-up), anticipated trial length one year.

Participants must be assessed at least 4 weeks after surgery to begin treatment in the adaptive randomized Phase 2 portion of the trial. PFS in participants in the surgical arm determined from the date of randomization to the treatment arms and not from the date of registration in the trial.

Study outcome measure period ended June 2015.

Outcome measures

Measure	Bevacizumab n=38 Participants Phase II Bevacizumab 10 mg/kg/dose IV on days 1 \& 15 of a 28 day cycle.	Bevacizumab + Vorinostat 400 mg n=47 Participants Phase II Bevacizumab 10 mg/kg/dose IV Day 1 \& 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 \& days 15 to 21 of a 28 day cycle.	Phase II: Bevacizumab + Vorinostat 400 mg Phase II Bevacizumab 10 mg/kg/dose IV Day 1 \& 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 \& days 15 to 21 of a 28 day cycle.
Progression Free Survival (PFS) at 6 Months	0.29 Months Interval 0.15 to 0.45	0.23 Months Interval 0.12 to 0.36	—

PRIMARY outcome

Timeframe: 28 day, cycle 1

MTD defined as the dose level at which 1/6 patients experience dose limiting toxicity (DLT), using conventional Phase I design where the MTD was selected using a 3+3 accrual design at each dose level until MTD was determined. Toxicities will be graded according to the Common Terminology Criteria for Adverse events (CTCAE) Version 4.0.

Outcome measures

Measure	Bevacizumab n=6 Participants Phase II Bevacizumab 10 mg/kg/dose IV on days 1 \& 15 of a 28 day cycle.	Bevacizumab + Vorinostat 400 mg Phase II Bevacizumab 10 mg/kg/dose IV Day 1 \& 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 \& days 15 to 21 of a 28 day cycle.	Phase II: Bevacizumab + Vorinostat 400 mg Phase II Bevacizumab 10 mg/kg/dose IV Day 1 \& 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 \& days 15 to 21 of a 28 day cycle.
Maximum Tolerated Dose (MTD) of Oral Vorinostat Used With Bevacizumab	400 mg/day	—	—

SECONDARY outcome

Timeframe: 3, 6, and 12 months from patient registration

Progression defined by the Modified MacDonald criteria is 25% increase in the sum of products, of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any lesion/site, OR failure to return for evaluation due to health or deteriorating condition (unless clearly unrelated to this cancer).

Outcome measures

Measure	Bevacizumab n=38 Participants Phase II Bevacizumab 10 mg/kg/dose IV on days 1 \& 15 of a 28 day cycle.	Bevacizumab + Vorinostat 400 mg n=47 Participants Phase II Bevacizumab 10 mg/kg/dose IV Day 1 \& 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 \& days 15 to 21 of a 28 day cycle.	Phase II: Bevacizumab + Vorinostat 400 mg Phase II Bevacizumab 10 mg/kg/dose IV Day 1 \& 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 \& days 15 to 21 of a 28 day cycle.
Time to Progression (TTP) Overall TTP	4.07 Months Interval 1.94 to 5.88	3.71 Months Interval 2.73 to 4.63	—
Time to Progression (TTP) 3 months	0.59 Months Interval 0.41 to 0.73	0.62 Months Interval 0.46 to 0.74	—
Time to Progression (TTP) 6 months	0.29 Months Interval 0.15 to 0.45	0.28 Months Interval 0.15 to 0.42	—
Time to Progression (TTP) 12 months	0.06 Months Interval 0.01 to 0.19	0.15 Months Interval 0.06 to 0.29	—

SECONDARY outcome

Timeframe: up to 30 months.

OS was computed using the number of months from the date of randomization to the date of death, up to 30 months. Participants still alive were censored at the last follow-up date.

Outcome measures

Measure	Bevacizumab n=38 Participants Phase II Bevacizumab 10 mg/kg/dose IV on days 1 \& 15 of a 28 day cycle.	Bevacizumab + Vorinostat 400 mg n=47 Participants Phase II Bevacizumab 10 mg/kg/dose IV Day 1 \& 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 \& days 15 to 21 of a 28 day cycle.	Phase II: Bevacizumab + Vorinostat 400 mg Phase II Bevacizumab 10 mg/kg/dose IV Day 1 \& 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 \& days 15 to 21 of a 28 day cycle.
Overall Survival (OS)	9.24 Months Interval 5.88 to 11.4	7.80 Months Interval 5.04 to 9.12	—

SECONDARY outcome

Timeframe: Baseline before treatment, Cycle 1 Day 2, day 15 (pre-infusion and post-infusion), Cycle 2 (pre-infusion)

Population: This outcome measure was not done. A few samples were collected and stored. However, the correlative biology was predicated on adequate acquisition of tumor tissue and funding. unfortunately, we were unable to obtain funding to perform this aspect (i.e. analysis) of the study.

About 5cc of blood was collected to measure plasma angiogenic proteins vascular endothelial growth factor (VEGF), placental growth factor (PIGF), and basic fibroblast growth factor (bFGF) by enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline before treatment, Cycle 1 Day 2, day 15 (pre-infusion and post-infusion), Cycle 2 (pre-infusion)

Population: This outcome measure was not done. A few samples were collected and stored. However, the correlative biology was predicated on adequate acquisition of tumor tissue and funding. unfortunately, we were unable to obtain funding to perform this aspect (i.e. analysis) of the study.

About 5cc of blood was collected to measure plasma angiogenic proteins stromal cell-derived factor α (SDF1α), angiopoietin 1 and 2 by enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, week 4, week 8, and end of therapy, approximately week 52 (cycle 12)

Population: Reason outcome measure #7 is not done per arm/group is it was intentionally not completed due to negative findings of the study's primary outcomes.

Percentage of patients rating their symptoms to be 7 or greater on a 0-10 scale using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool. Zero is "not present" and 10 is "as bad as you can imagine. All patients with at least one valid questionnaire will be included in the analyses. Differences of at least 2 points will be classified as the minimum clinically meaningful change in the symptom severity and symptom interference measures.

Outcome measures

Measure	Bevacizumab n=50 Participants Phase II Bevacizumab 10 mg/kg/dose IV on days 1 \& 15 of a 28 day cycle.	Bevacizumab + Vorinostat 400 mg Phase II Bevacizumab 10 mg/kg/dose IV Day 1 \& 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 \& days 15 to 21 of a 28 day cycle.	Phase II: Bevacizumab + Vorinostat 400 mg Phase II Bevacizumab 10 mg/kg/dose IV Day 1 \& 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 \& days 15 to 21 of a 28 day cycle.
Percentage of Patients Rating Their Symptoms to be 7 or Greater on a 0-10 Scale Using the Mean Severity of the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) Self Reporting Tool Baseline	2 percentage of of participants	—	—
Percentage of Patients Rating Their Symptoms to be 7 or Greater on a 0-10 Scale Using the Mean Severity of the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) Self Reporting Tool Cycle 2, week 4	0 percentage of of participants	—	—
Percentage of Patients Rating Their Symptoms to be 7 or Greater on a 0-10 Scale Using the Mean Severity of the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) Self Reporting Tool Cycle 4, week 8	0 percentage of of participants	—	—
Percentage of Patients Rating Their Symptoms to be 7 or Greater on a 0-10 Scale Using the Mean Severity of the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) Self Reporting Tool End ot therapy, week 52	0 percentage of of participants	—	—

SECONDARY outcome

Timeframe: Baseline, week 4 (cycle 2), week 8 (cycle 4), and end of therapy, approximately week 52 (cycle 12)

Population: Overall analysis was done but not done by treatment arm/group.

Overall mean severity of 22 symptoms. Symptoms are rated 0-10, zero is "not present" and 10 is "as bad as you can imagine". All patients with at least one valid questionnaire will be included in the analyses.

Outcome measures

Measure	Bevacizumab n=50 Participants Phase II Bevacizumab 10 mg/kg/dose IV on days 1 \& 15 of a 28 day cycle.	Bevacizumab + Vorinostat 400 mg Phase II Bevacizumab 10 mg/kg/dose IV Day 1 \& 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 \& days 15 to 21 of a 28 day cycle.	Phase II: Bevacizumab + Vorinostat 400 mg Phase II Bevacizumab 10 mg/kg/dose IV Day 1 \& 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 \& days 15 to 21 of a 28 day cycle.
Mean Symptom Severity Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool Baseline	1.6 score on a scale Standard Deviation 1.5	—	—
Mean Symptom Severity Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool Cycle 2	1.3 score on a scale Standard Deviation 1.1	—	—
Mean Symptom Severity Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool Cycle 4	1.9 score on a scale Standard Deviation 1.6	—	—
Mean Symptom Severity Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Self Reporting Tool End of therapy	2.2 score on a scale Standard Deviation 1.7	—	—

SECONDARY outcome

Timeframe: Baseline, (cycle 2), week 8 (cycle 4), and end of therapy, approximately week 52 (cycle 12)

Population: Overall analysis was done but not done by treatment arm/group.

Overall mean interference severity of 6 interference items. Interference is rated 0-10, zero is "did not interfere" and 10 is "as bad as you can imagine". All patients with at least one valid questionnaire will be included in the analyses.

Outcome measures

Measure	Bevacizumab n=50 Participants Phase II Bevacizumab 10 mg/kg/dose IV on days 1 \& 15 of a 28 day cycle.	Bevacizumab + Vorinostat 400 mg Phase II Bevacizumab 10 mg/kg/dose IV Day 1 \& 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 \& days 15 to 21 of a 28 day cycle.	Phase II: Bevacizumab + Vorinostat 400 mg Phase II Bevacizumab 10 mg/kg/dose IV Day 1 \& 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 \& days 15 to 21 of a 28 day cycle.
Mean Symptom Interference at the Time of Clinical Evaluation Baseline	2.2 score on a scale Standard Deviation 2.4	—	—
Mean Symptom Interference at the Time of Clinical Evaluation Cycle 2	1.7 score on a scale Standard Deviation 1.7	—	—
Mean Symptom Interference at the Time of Clinical Evaluation Cycle 4	2.9 score on a scale Standard Deviation 2.4	—	—
Mean Symptom Interference at the Time of Clinical Evaluation End of therapy	2.9 score on a scale Standard Deviation 2.6	—	—

SECONDARY outcome

Timeframe: End of therapy, approximately

Population: This outcome measure was not done. We collected radiological response data provided by the local physician at time points per protocol. At the end of the study, the plan was to send all MRI discs to one radiologist for central review to confirm responses. With only limited funding, and negative findings, the PI decided to not pursue this outcome.

Magnetic resonance imaging (MRI) and contrast-enhanced (CE) MRI was used to evaluate tumor response. Response is defined by the Modified MacDonald criteria. Complete Response (CR) is complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. Partial Response, Non-Measurable (PRNM) is not applicable. Stable/No Response does not qualify for CR, PR or progression. Progression is 25% increase in the sum of products, of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any lesion/site, OR failure to return for evaluation due to health or deteriorating condition (unless clearly unrelated to this cancer).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle.

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Measure	Bevacizumab n=6 Participants Phase II Bevacizumab 10 mg/kg/dose IV on days 1 \& 15 of a 28 day cycle.	Bevacizumab + Vorinostat 400 mg n=38 Participants Phase II Bevacizumab 10 mg/kg/dose IV Day 1 \& 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 \& days 15 to 21 of a 28 day cycle.	Phase II: Bevacizumab + Vorinostat 400 mg n=47 Participants Phase II Bevacizumab 10 mg/kg/dose IV Day 1 \& 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 \& days 15 to 21 of a 28 day cycle.
Number of Participants With Serious and Non-Serious Adverse Events	6 Participants	38 Participants	47 Participants

Adverse Events

Phase I: Vorinostat + Bevacizumab

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Phase II: Bevacizumab

Serious events: 10 serious events

Other events: 36 other events

Deaths: 0 deaths

Phase II: Bevacizumab + Vorinostat 400 mg

Serious events: 14 serious events

Other events: 43 other events

Deaths: 1 deaths

Serious adverse events

Measure	Phase I: Vorinostat + Bevacizumab n=6 participants at risk Phase I Vorinostat starting dose 400 mg orally days 1 - 7 \& days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 \& 15 of 28 day cycle.	Phase II: Bevacizumab n=38 participants at risk Phase II Bevacizumab 10 mg/kg/dose IV on days 1 \& 15 of a 28 day cycle.	Phase II: Bevacizumab + Vorinostat 400 mg n=47 participants at risk Phase II Bevacizumab 10 mg/kg/dose IV Day 1 \& 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 \& days 15 to 21 of a 28 day cycle.
Cardiac disorders Atrial fibrillation	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Psychiatric disorders Cognitive disturbance	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Colonic perforation	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Constipation	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
General disorders Death NOS	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Edema cerebral	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Investigations Ejection fraction decreased	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Encephalopathy	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Headache	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Vascular disorders Hypertension	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Respiratory, thoracic and mediastinal disorders Infections and infestations	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Intracranial hemorrhage	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Lethargy	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Nausea	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
General disorders Non-cardiac chest pain	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
General disorders Pain	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Seizure	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	7.9% 3/38 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Stroke	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Syncope	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Vascular disorders Thromboembolic event	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	10.6% 5/47 • Number of events 5 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Renal and urinary disorders Urinary retention	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Vomiting	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Infections and infestations Wound infection	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Blood and lymphatic system disorders Blood and Lymphatic System Disorders, Other, specify	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders, Other specify	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Renal and urinary disorders Renal and urinary disorders, Other, specify	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.

Other adverse events

Measure	Phase I: Vorinostat + Bevacizumab n=6 participants at risk Phase I Vorinostat starting dose 400 mg orally days 1 - 7 \& days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 \& 15 of 28 day cycle.	Phase II: Bevacizumab n=38 participants at risk Phase II Bevacizumab 10 mg/kg/dose IV on days 1 \& 15 of a 28 day cycle.	Phase II: Bevacizumab + Vorinostat 400 mg n=47 participants at risk Phase II Bevacizumab 10 mg/kg/dose IV Day 1 \& 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 \& days 15 to 21 of a 28 day cycle.
Metabolism and nutrition disorders Hypocalcemia	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	7.9% 3/38 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Abdominal distension	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	10.5% 4/38 • Number of events 5 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Ear and labyrinth disorders Ear and labyrinth disorders, Other, specify	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Endocrine disorders Adrenal insufficiency	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Psychiatric disorders Agitation	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Investigations Alanine aminotransferase (ALT) increased	33.3% 2/6 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	8.5% 4/47 • Number of events 6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Akathisia	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Investigations Alkaline phosphatase increased	33.3% 2/6 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	6.4% 3/47 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Immune system disorders Allergic reaction	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	6.4% 3/47 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Amnesia	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Blood and lymphatic system disorders Anemia	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	7.9% 3/38 • Number of events 6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	12.8% 6/47 • Number of events 8 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders Anorexia	33.3% 2/6 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	13.2% 5/38 • Number of events 5 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	31.9% 15/47 • Number of events 17 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Psychiatric disorders Anxiety	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	6.4% 3/47 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Investigations Aspartate aminotransferase (AST) increased	33.3% 2/6 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	6.4% 3/47 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Ataxia	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders Bicarbonate Serum-low	66.7% 4/6 • Number of events 6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Bloating	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Investigations Blood bilirubin increased	16.7% 1/6 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	6.4% 3/47 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Eye disorders Blurred vision	16.7% 1/6 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Infections and infestations Bronchial infection	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Injury, poisoning and procedural complications Bruising	33.3% 2/6 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	10.5% 4/38 • Number of events 5 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Injury, poisoning and procedural complications Burn	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Cardiac disorders Chest pain - cardiac	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
General disorders Chills	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Investigations Cholesterol high	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Cognitive disturbance	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	13.2% 5/38 • Number of events 6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	12.8% 6/47 • Number of events 8 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Concentration impairment	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Psychiatric disorders Confusion	33.3% 2/6 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	7.9% 3/38 • Number of events 5 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	6.4% 3/47 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Eye disorders Conjunctivitis	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Constipation	66.7% 4/6 • Number of events 6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	10.5% 4/38 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	23.4% 11/47 • Number of events 11 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	18.4% 7/38 • Number of events 8 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	10.6% 5/47 • Number of events 6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Investigations Creatinine increased	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	10.5% 4/38 • Number of events 7 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	6.4% 3/47 • Number of events 5 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Endocrine disorders Cushingoid	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Skin and subcutaneous tissue disorders DECUBITUS Ulcer Sacrum	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders Dehydration	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Dental caries	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Psychiatric disorders Depression	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	7.9% 3/38 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	10.6% 5/47 • Number of events 5 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Skin and subcutaneous tissue disorders Bump at sutura site	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Skin and subcutaneous tissue disorders Multiple scabs	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Diarrhea	33.3% 2/6 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	10.5% 4/38 • Number of events 6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	19.1% 9/47 • Number of events 20 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Eye disorders Diplopia	33.3% 2/6 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Dizziness	66.7% 4/6 • Number of events 5 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	7.9% 3/38 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	23.4% 11/47 • Number of events 11 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Eye disorders Dry eye	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Dry mouth	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	6.4% 3/47 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Dysarthria	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Dysgeusia	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Dysphagia	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Dysphasia	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	10.5% 4/38 • Number of events 6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	12.8% 6/47 • Number of events 6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Edema cerebral	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
General disorders Edema face	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
General disorders Edema limbs	50.0% 3/6 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	15.8% 6/38 • Number of events 8 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	7.9% 3/38 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	8.5% 4/47 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Eye disorders Eye disorders - Other, specify	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	14.9% 7/47 • Number of events 10 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Facial nerve disorder	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	7.9% 3/38 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	10.6% 5/47 • Number of events 6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
General disorders Fatigue	100.0% 6/6 • Number of events 11 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	26.3% 10/38 • Number of events 16 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	46.8% 22/47 • Number of events 31 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Fecal incontinence	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
General disorders Fever	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Flatulence	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Investigations Flu like symptoms	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
General disorders Gait disturbance	66.7% 4/6 • Number of events 7 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	13.2% 5/38 • Number of events 8 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	8.5% 4/47 • Number of events 5 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
General disorders Gait/walking (wide based ataxic hemiparetic)	33.3% 2/6 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
General disorders Gait/walking Impaired mobility	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Gastric ulcer	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	6.4% 3/47 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Gastrointestinal (sensitivity to smell)	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	7.9% 3/38 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	6.4% 3/47 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
General disorders General disorders and administration site conditions - Other, specify	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	6.4% 3/47 • Number of events 6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Headache	100.0% 6/6 • Number of events 10 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	28.9% 11/38 • Number of events 14 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	23.4% 11/47 • Number of events 21 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Heartburn	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Vascular disorders Hematoma	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Investigations Hemoglobin Increase	83.3% 5/6 • Number of events 9 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Hemorrhoids	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Respiratory, thoracic and mediastinal disorders Hiccups	16.7% 1/6 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	8.5% 4/47 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders Hyperglycemia	33.3% 2/6 • Number of events 19 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	26.3% 10/38 • Number of events 17 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	21.3% 10/47 • Number of events 18 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Hypersomnia	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Vascular disorders Hypertension	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	50.0% 19/38 • Number of events 57 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	38.3% 18/47 • Number of events 41 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders Hypertriglycedidemia	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders Hyperuricemia	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders Hypoalbuminemia	50.0% 3/6 • Number of events 6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders Hypoglycemia	33.3% 2/6 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	6.4% 3/47 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders Hypokalemia	33.3% 2/6 • Number of events 6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	10.5% 4/38 • Number of events 5 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	8.5% 4/47 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders Hyponatremia	50.0% 3/6 • Number of events 9 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	10.5% 4/38 • Number of events 5 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders Hypophosphatemia	33.3% 2/6 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Vascular disorders Hypotension	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Infections and infestations Infection with Normal ANC (Neck NOS), cellulitis	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Infections and infestations Infection with Normal ANC (Neck NOS), herpes zoster	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Infections and infestations Infection with Normal ANC (Neck NOS), (Urinary Tract NOS)	50.0% 3/6 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Infections and infestations Infection with Normal ANC (Wound), Herpes Z-back-perineal-scrutum	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Infections and infestations Infections and infestations	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	15.8% 6/38 • Number of events 6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
General disorders Infusion related reaction	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Investigations International normalized ratio (INR) increased	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Psychiatric disorders Insomnia	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	7.9% 3/38 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	8.5% 4/47 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Investigations Investigations - Other, specify	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Reproductive system and breast disorders Irregular Menses	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Musculoskeletal and connective tissue disorders Joint Pain	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Lethargy	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Blood and lymphatic system disorders Leukocytosis	50.0% 3/6 • Number of events 10 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
General disorders Localized edema	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	7.9% 3/38 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Investigations Lymphocyte count decreased	83.3% 5/6 • Number of events 24 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	18.4% 7/38 • Number of events 8 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	8.5% 4/47 • Number of events 10 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Investigations Lymphocyte count increased	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
General disorders Malaise	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Memory impairment	66.7% 4/6 • Number of events 5 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	26.3% 10/38 • Number of events 11 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	23.4% 11/47 • Number of events 13 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Psychiatric disorders Mental Status Altered	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders METABOLIC/LABORATORY (Elevated BUN)	50.0% 3/6 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders METABOLIC/LABORATORY (elevated LDH)	50.0% 3/6 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders METABOLIC/LABORATORY (high chloride)	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders METABOLIC/LABORATORY (low chloride)	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders METABOLIC/LABORATORY (low creatinine)	33.3% 2/6 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders METABOLIC/LABORATORY (low protein)	33.3% 2/6 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Metabolism and nutrition disorders METABOLIC/LABORATORY (low uric acid)	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Ear and labyrinth disorders Middle ear inflammation	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Psychiatric disorders Mood Alteration	50.0% 3/6 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Movements involuntary	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Infections and infestations Mucosal infection	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Mucositis oral	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Musculoskeletal and connective tissue disorders Muscle weakness- Whole body/generalized	33.3% 2/6 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Musculoskeletal and connective tissue disorders Muscle weakness lower extremity	33.3% 2/6 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	14.9% 7/47 • Number of events 8 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Musculoskeletal and connective tissue disorders Muscle weakness right-sided	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	13.2% 5/38 • Number of events 5 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	14.9% 7/47 • Number of events 10 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	7.9% 3/38 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	10.5% 4/38 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Nausea	83.3% 5/6 • Number of events 8 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	15.8% 6/38 • Number of events 7 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	34.0% 16/47 • Number of events 20 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	23.4% 11/47 • Number of events 24 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Neuropathy, Numbness, Right sided	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Neuropathy, Cranial (Pupil, Upper eyelid)	33.3% 2/6 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Neuropathy, Sensory Legs/Toes tingling	33.3% 2/6 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Investigations Neutrophil count decreased	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	17.0% 8/47 • Number of events 16 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
General disorders Non-cardiac chest pain	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Nystagmus	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Obstruction GI (STOMACH-small bowel nos)	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Eye disorders OCULAR SURFACE DISEASE	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Eye disorders OCULAR/VISUAL (Right homonymous hemianopsia)	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Eye disorders OCULAR/VISUAL (Right & Left visual field deficits)	33.3% 2/6 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Oral hemorrhage	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Oral pain	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
General disorders Pain	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	12.8% 6/47 • Number of events 8 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Musculoskeletal and connective tissue disorders PAIN (BACK)	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Musculoskeletal and connective tissue disorders Pain (Neuropathic in perineal/buttock)	16.7% 1/6 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	8.5% 4/47 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Paresthesia	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	10.6% 5/47 • Number of events 6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Infections and infestations Paronychia	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Eye disorders Photophobia	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Investigations Platelet count decreased	83.3% 5/6 • Number of events 5 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	15.8% 6/38 • Number of events 9 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	23.4% 11/47 • Number of events 19 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Renal and urinary disorders Proteinuria	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	7.9% 3/38 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Skin and subcutaneous tissue disorders Pruritus	16.7% 1/6 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	7.9% 3/38 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Psychiatric disorders Psychiatric disorders - Other, specify	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Pyramidal Tract Dysfunction	66.7% 4/6 • Number of events 8 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	8.5% 4/47 • Number of events 5 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	10.5% 4/38 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Renal and urinary disorders Renal and urinary disorders - Other, specify	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Psychiatric disorders Restlessness	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Infections and infestations Rhinitis infective	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Seizure	33.3% 2/6 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	13.2% 5/38 • Number of events 7 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	12.8% 6/47 • Number of events 7 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Sensory loss left side	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Cardiac disorders Sinus bradycardia	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Sinus pain	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Cardiac disorders Sinus tachycardia	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	8.5% 4/47 • Number of events 5 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Infections and infestations Sinusitis	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	10.5% 4/38 • Number of events 8 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	6.4% 3/47 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Skin and subcutaneous tissue disorders Skin infection	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Somnolence	33.3% 2/6 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Respiratory, thoracic and mediastinal disorders Sore throat	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	8.5% 4/47 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Speech Impairment	50.0% 3/6 • Number of events 5 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Stomach pain	33.3% 2/6 • Number of events 3 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Stroke	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Taste Alteration	33.3% 2/6 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Skin and subcutaneous tissue disorders Telangiectasia	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Vascular disorders Thromboembolic event	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Ear and labyrinth disorders Tinnitus	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Infections and infestations Tooth infection	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Tremor	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Infections and infestations Upper respiratory infection	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Renal and urinary disorders Urinary frequency	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Renal and urinary disorders Urinary incontinence	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	7.9% 3/38 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Ear and labyrinth disorders Vertigo	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Respiratory, thoracic and mediastinal disorders Voice alteration	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Gastrointestinal disorders Vomiting	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	10.6% 5/47 • Number of events 6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Investigations Weight gain	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	6.4% 3/47 • Number of events 4 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Investigations Weight loss	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	7.9% 3/38 • Number of events 5 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	12.8% 6/47 • Number of events 6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Investigations White blood cell decreased	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	5.3% 2/38 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	10.6% 5/47 • Number of events 13 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Infections and infestations Wound infection	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	4.3% 2/47 • Number of events 2 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Nervous system disorders Encephalopathy	0.00% 0/6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.1% 1/47 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Infections and infestations Urinary tract infection	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	2.6% 1/38 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	6.4% 3/47 • Number of events 6 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.
Skin and subcutaneous tissue disorders Hyperpigmentation (hands & knuckles)	16.7% 1/6 • Number of events 1 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/38 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.	0.00% 0/47 • Phase I adverse events collected within 4 week (28 day) cycle. Phase II evaluated for adverse events after each cycle for first 2 cycles and subsequently after each 2 cycles of treatment prior to initiating the next cycle. The summary is based on the information of the 85 treated patients. A total of 1098 adverse events have been observed in 82 patients after they started the treatment.

Additional Information

Dr. Mark Gilbert

National Cancer Institute

Phone: 301-402-6383

Email: gilbertmr@mail.nih.gov

Results disclosure agreements

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

Restriction type: GT60