Trial Outcomes & Findings for BIBF 1120 in Bevacizumab Resistant, Persistent, or Recurrent Epithelial Ovarian Cancer (NCT NCT01669798)

Last Updated: 2018-10-16

Results Overview

Measure of Progression Free Survival (PFS) by the percentage of patients who survive progression-free for at least 6 months after initiating study therapy in patients with bevacizumab-resistant, persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

6 months

Results posted on

2018-10-16

Participant Flow

Patients were enrolled from February of 2013 to July of 2017 at three cancer clinics in North Carolina and Virginia.

Participant milestones

Participant milestones
Measure	BIBF 1120 BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy. BIBF 1120: PO 200mg BID
Overall Study STARTED	32
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	BIBF 1120 BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy. BIBF 1120: PO 200mg BID
Overall Study Physician Decision	5

Baseline Characteristics

BIBF 1120 in Bevacizumab Resistant, Persistent, or Recurrent Epithelial Ovarian Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BIBF 1120 n=27 Participants BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy. BIBF 1120: PO 200mg BID
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Primary site of tumor Ovary	26 Participants n=5 Participants
Primary site of tumor Peritoneum	1 Participants n=5 Participants
Histologic tumor type Adenocarcinoma, Unspecified	1 Participants n=5 Participants
Histologic tumor type Clear Cell Carcinoma	1 Participants n=5 Participants
Histologic tumor type Other: Poorly Differentiated Adenocarcinoma	1 Participants n=5 Participants
Histologic tumor type Serous Adenocarcinoma	24 Participants n=5 Participants
Platinum based treatment resistant/sensitive Platinum Resistant	22 Participants n=5 Participants
Platinum based treatment resistant/sensitive Platinum Sensitive	5 Participants n=5 Participants
Antecedent Bevacizumab (bev) therapy prior to starting trial Front-line chemo with bev, plus bev maintenance	9 Participants n=5 Participants
Antecedent Bevacizumab (bev) therapy prior to starting trial Front-line chemo with bev, without bev maintenance	2 Participants n=5 Participants
Antecedent Bevacizumab (bev) therapy prior to starting trial Second-line chemo with bev, plus bev maintenance	5 Participants n=5 Participants
Antecedent Bevacizumab (bev) therapy prior to starting trial Secon-line chemo with bev, without bev maintenance	4 Participants n=5 Participants
Antecedent Bevacizumab (bev) therapy prior to starting trial Second line single agent bevacizumab	6 Participants n=5 Participants
Antecedent Bevacizumab (bev) therapy prior to starting trial Third-line chemotherapy plus bevacizumab	1 Participants n=5 Participants
Number of prior therapy regimens One prior regimen	8 Participants n=5 Participants
Number of prior therapy regimens Two prior regimens	10 Participants n=5 Participants
Number of prior therapy regimens Three prior regimens	7 Participants n=5 Participants
Number of prior therapy regimens Four prior regimens	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: The analysis was to be based on 27 evaluable patients for the first stage. Subjects were considered evaluable if they completed at least one cycle of study drug. Of the 27 subjects, one was not considered evaluable because they did not receive a full cycle.

Outcome measures

Outcome measures
Measure	BIBF 1120 n=26 Participants BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy. BIBF 1120: PO 200mg BID
Percentage of Patients Who Survive Progression-free	11.5 percentage of participants Interval 2.5 to 30.2

SECONDARY outcome

Timeframe: 1 year

Population: Responders are those who achieved a partial response (PR). No subjects achieved a complete response (CR).

Evaluating the percentage of patients who have objective tumor response (complete or partial) based on RECIST 1.1 criteria.

Outcome measures

Outcome measures
Measure	BIBF 1120 n=27 Participants BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy. BIBF 1120: PO 200mg BID
Objective Tumor Response Via RECIST (Response Evaluation Criteria in Solid Tumors) 1.1	7.4 percentage of participants Interval 0.9 to 24.3

SECONDARY outcome

Timeframe: Through study completion, on average 2 years

Population: Analysis stratified results between PFS (Progression Free Survival) and OS (Overall Survival). Confidence interval and results based on Kaplan Meier Estimates.

The duration of progression-free survival and overall survival measured in months; Progression-Free Survival (PFS) is defined as the duration of time from study entry to time of progression or death, whichever occurs first.

Outcome measures

Outcome measures
Measure	BIBF 1120 n=27 Participants BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy. BIBF 1120: PO 200mg BID
Duration of Progression-Free Survival Progression Free Survival (PFS)	1.8 Months Interval 1.6 to 3.5
Duration of Progression-Free Survival Overall Survival (OS)	16 Months Interval 8.0 to 25.0

SECONDARY outcome

Timeframe: 1 year

Population: Twenty five subjects were analyzed based on the Gynaecologic Cancer Intergroup response CA125 response criteria. Two subjects data were unavailable.

The proportion of patients who have objective tumor response (complete or partial) based on Gynaecologic Cancer InterGroup(GCIG) CA-125 criteria which is: "A response according to CA 125 has occurred if there is at least a 50% reduction in CA 125 levels from a pretreatment sample. The response must be confirmed and maintained for at least 28 days.".

Outcome measures

Outcome measures
Measure	BIBF 1120 n=25 Participants BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy. BIBF 1120: PO 200mg BID
Objective Tumor Response Based on GCIG CA-125 Criteria	0 Participants

SECONDARY outcome

Timeframe: 1 year

Population: All adverse events considered possible, probably, or definitely related to study drug. Reported regardless of severity.

To determine frequency and severity of adverse events as assessed using NCI Common Toxicity Criteria version 4.

Outcome measures

Outcome measures
Measure	BIBF 1120 n=27 Participants BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy. BIBF 1120: PO 200mg BID
Adverse Event Frequency and Severity Proteinuria	4 Participants
Adverse Event Frequency and Severity Urinary incontinence	1 Participants
Adverse Event Frequency and Severity Vaginal dryness	1 Participants
Adverse Event Frequency and Severity Vaginal pain	1 Participants
Adverse Event Frequency and Severity Atelectasis	1 Participants
Adverse Event Frequency and Severity Dyspnea	2 Participants
Adverse Event Frequency and Severity Pleural effusion	1 Participants
Adverse Event Frequency and Severity Wheezing	1 Participants
Adverse Event Frequency and Severity Rash maculo-papular	1 Participants
Adverse Event Frequency and Severity Hypertension	4 Participants
Adverse Event Frequency and Severity Intermittent leg cramps	1 Participants
Adverse Event Frequency and Severity Bilateral neuropathy, hands and feet	1 Participants
Adverse Event Frequency and Severity Anemia	2 Participants
Adverse Event Frequency and Severity Sinus tachycardia	1 Participants
Adverse Event Frequency and Severity Tinnitus	1 Participants
Adverse Event Frequency and Severity Abdominal pain	7 Participants
Adverse Event Frequency and Severity Bloating	3 Participants
Adverse Event Frequency and Severity Diarrhea	17 Participants
Adverse Event Frequency and Severity Dry mouth	1 Participants
Adverse Event Frequency and Severity Constipation	4 Participants
Adverse Event Frequency and Severity Dyspepsia	1 Participants
Adverse Event Frequency and Severity Gastroesophageal reflux disease	1 Participants
Adverse Event Frequency and Severity Nausea	17 Participants
Adverse Event Frequency and Severity Vomiting	13 Participants
Adverse Event Frequency and Severity Chills	1 Participants
Adverse Event Frequency and Severity Edema limbs	3 Participants
Adverse Event Frequency and Severity Fatigue	14 Participants
Adverse Event Frequency and Severity Non-cardiac chest pain	1 Participants
Adverse Event Frequency and Severity Alanine aminotransferase increased	10 Participants
Adverse Event Frequency and Severity Alkaline phosphatase increased	8 Participants
Adverse Event Frequency and Severity Aspartate aminotransferase increased	12 Participants
Adverse Event Frequency and Severity Creatinine increased	1 Participants
Adverse Event Frequency and Severity Neutrophil count decreased	1 Participants
Adverse Event Frequency and Severity Platelet count decreased	2 Participants
Adverse Event Frequency and Severity Weight loss	3 Participants
Adverse Event Frequency and Severity Anorexia	4 Participants
Adverse Event Frequency and Severity Hypoalbuminemia	2 Participants
Adverse Event Frequency and Severity Hypocalcemia	1 Participants
Adverse Event Frequency and Severity Hypomagnesemia	4 Participants
Adverse Event Frequency and Severity Hyponatremia	4 Participants
Adverse Event Frequency and Severity Arthralgia	4 Participants
Adverse Event Frequency and Severity Arthritis	1 Participants
Adverse Event Frequency and Severity Back Pain	2 Participants
Adverse Event Frequency and Severity Bone pain	1 Participants
Adverse Event Frequency and Severity Pain in extremity	1 Participants
Adverse Event Frequency and Severity Dysgeusia	2 Participants
Adverse Event Frequency and Severity Headache	8 Participants
Adverse Event Frequency and Severity Hematuria	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Biomarker levels measured and stratified into two groups: those who experienced either Partial Response (PR) or Stable Disease (SD); and those who experienced Progressive Disease (PD). Data was not collected for one subject.

Correlating baseline and on treatment levels of additional growth factors measured in picograms per milliliter that may be co- or counter- regulated with VEGF with response to treatment

Outcome measures

Outcome measures
Measure	BIBF 1120 n=26 Participants BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy. BIBF 1120: PO 200mg BID
Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response CD73: Partial Response or Stable Disease	3.0 picograms per milliliter Interval 1.8 to 3.4
Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response CD73: Progressive Disease	3.8 picograms per milliliter Interval 2.6 to 5.0
Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response HGF: Partial Response or Stable Disease	130.1 picograms per milliliter Interval 78.3 to 188.2
Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response HGF: Progressive Disease	191.0 picograms per milliliter Interval 72.1 to 517.4
Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response IL-6: Partial Response or Stable Disease	18.2 picograms per milliliter Interval 8.9 to 28.5
Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response PDGF-BB: Partial Response or Stable Disease	184.7 picograms per milliliter Interval 26.7 to 325.6
Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response PDGF-BB (pg/ml): PD	396.4 picograms per milliliter Interval 91.1 to 769.2
Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response PIGF: Partial Response or Stable Disease	23.4 picograms per milliliter Interval 21.5 to 27.9
Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response BMP-9: Partial Response or Stable Disease	47.0 picograms per milliliter Interval 39.0 to 62.7
Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response BMP-9: Progressive Disease	45.9 picograms per milliliter Interval 36.2 to 48.3
Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response IL-6: Progressive Disease	32.6 picograms per milliliter Interval 16.5 to 50.5
Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response PDGF-AA: Partial Response or Stable Disease	89.5 picograms per milliliter Interval 27.7 to 347.4
Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response PDGF-AA: Progressive Disease	233.9 picograms per milliliter Interval 47.1 to 419.6
Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response PIGF: Progressive Disease	24.3 picograms per milliliter Interval 14.2 to 30.5
Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response SDF-1: Partial Response or Stable Disease	1968.6 picograms per milliliter Interval 1453.7 to 3021.0
Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response SDF-1: Progressive Disease	2121.9 picograms per milliliter Interval 1199.4 to 3360.0
Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response TGFBeta-R3: Partial Respone or Stable Disease	50.6 picograms per milliliter Interval 32.8 to 71.0
Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response TGFBeta-R3: Progressive Disease	52.5 picograms per milliliter Interval 45.4 to 57.3
Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response Ang2: Partial Response or Stable Disease	261.1 picograms per milliliter Interval 141.6 to 456.1
Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response Ang2: Progressive Disease	189.5 picograms per milliliter Interval 146.7 to 222.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: We initially planned to measure baseline and on treatment levels of coagulation and endothelial cell activation markers that may predict for thrombotic or bleeding risks related to treatment. These markers are best analyzed in citrated plasma and funding was not available for tube collection and analysis.

To measure baseline and on treatment levels of additional growth factors that may be co- or counter- regulated with VEGF and correlate with response to treatment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: VEGF levels measured and stratified into two groups: those who experienced either Partial Response (PR) or Stable Disease (SD); and those who experienced Progressive Disease (PD). Data was not collected for one subject

Baseline levels of VEGF were correlated with treatment outcome. Results are stratified in groups: "Partial Response (PR) or Stable Disease (SD)" and "Progressive Disease (PD)"

Outcome measures

Outcome measures
Measure	BIBF 1120 n=26 Participants BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy. BIBF 1120: PO 200mg BID
VEGF Levels Correlated With Treatment Outcome Partial Response or Stable Disease	1405 picograms per milliliter Interval 958.0 to 1580.0
VEGF Levels Correlated With Treatment Outcome Progressive Disease	1033 picograms per milliliter Interval 698.0 to 1199.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Correlating baseline and on treatment levels of additional growth factors measured in nanograms per milliliter that may be co- or counter- regulated with VEGF with response to treatment

Outcome measures

Outcome measures
Measure	BIBF 1120 n=26 Participants BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy. BIBF 1120: PO 200mg BID
Concentration of Select Growth Factors Measured in Nanograms Per Milliliter Reported as a Function of Treatment Response TIMP-1: Partial Response or Stable Disease	93.5 nanograms per milliliter Interval 72.2 to 108.7
Concentration of Select Growth Factors Measured in Nanograms Per Milliliter Reported as a Function of Treatment Response TIMP-1: Progressive Disease	116.4 nanograms per milliliter Interval 88.2 to 141.9
Concentration of Select Growth Factors Measured in Nanograms Per Milliliter Reported as a Function of Treatment Response TSP-2: Partial Response or Stable Disease	95.1 nanograms per milliliter Interval 77.6 to 113.7
Concentration of Select Growth Factors Measured in Nanograms Per Milliliter Reported as a Function of Treatment Response ICAM-1: Partial Response or Stable Disease	635.1 nanograms per milliliter Interval 584.0 to 688.0
Concentration of Select Growth Factors Measured in Nanograms Per Milliliter Reported as a Function of Treatment Response ICAM-1: Progressive Disease	686.8 nanograms per milliliter Interval 589.0 to 951.0
Concentration of Select Growth Factors Measured in Nanograms Per Milliliter Reported as a Function of Treatment Response OPN: Partial Response or Stable Disease	643.0 nanograms per milliliter Interval 470.0 to 887.0
Concentration of Select Growth Factors Measured in Nanograms Per Milliliter Reported as a Function of Treatment Response OPN: Progressive Disease	923.0 nanograms per milliliter Interval 530.0 to 1349.0
Concentration of Select Growth Factors Measured in Nanograms Per Milliliter Reported as a Function of Treatment Response TGF-Beta1: Partial Response or Stable Disease	122.5 nanograms per milliliter Interval 93.4 to 134.6
Concentration of Select Growth Factors Measured in Nanograms Per Milliliter Reported as a Function of Treatment Response TGF-Beta1: Progressive Disease	90.3 nanograms per milliliter Interval 75.8 to 118.4
Concentration of Select Growth Factors Measured in Nanograms Per Milliliter Reported as a Function of Treatment Response TGF-Beta2: Partial Response or Stable Disease	22.0 nanograms per milliliter Interval 14.4 to 34.9
Concentration of Select Growth Factors Measured in Nanograms Per Milliliter Reported as a Function of Treatment Response TGF-Beta2: Progressive Disease	33.4 nanograms per milliliter Interval 14.4 to 57.2
Concentration of Select Growth Factors Measured in Nanograms Per Milliliter Reported as a Function of Treatment Response TSP-2: Progressive Disease	104.9 nanograms per milliliter Interval 91.5 to 169.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Correlating baseline and on treatment levels of VCAM-1 measured in micrograms per milliliter that may be co- or counter- regulated with VEGF with response to treatment

Outcome measures

Outcome measures
Measure	BIBF 1120 n=26 Participants BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy. BIBF 1120: PO 200mg BID
Concentration of VCAM-1 Reported as a Function of Treatment Response VCAM-1: Partial Response or Stable Disease	2.2 micrograms per milliliter Interval 1.8 to 2.5
Concentration of VCAM-1 Reported as a Function of Treatment Response VCAM-1: Progressive Disease	2.3 micrograms per milliliter Interval 1.6 to 2.8

Adverse Events

BIBF 1120

Serious events: 6 serious events

Other events: 27 other events

Deaths: 22 deaths

Serious adverse events

Serious adverse events
Measure	BIBF 1120 n=27 participants at risk BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy. BIBF 1120: PO 200mg BID
Gastrointestinal disorders Abdominal Pain	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Infections and infestations Kidney Infection	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
General disorders Non-cardiac chest pain	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Investigations Aspartate aminotransferase increased	7.4% 2/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Metabolism and nutrition disorders Hyponatremia	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Investigations Alanine aminotransferase increased	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.

Other adverse events

Other adverse events
Measure	BIBF 1120 n=27 participants at risk BIBF 1120 will be administered at a daily oral dose of 200 mg BID until disease progression or adverse effects prohibit further therapy. BIBF 1120: PO 200mg BID
Blood and lymphatic system disorders Anemia	18.5% 5/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Blood and lymphatic system disorders Leukocytosis	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Cardiac disorders Sinus tachycardia	7.4% 2/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Ear and labyrinth disorders Tinnitus	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Endocrine disorders Endocrine disorders - Other, specify	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Gastrointestinal disorders Abdominal distension	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Gastrointestinal disorders Abdominal pain	33.3% 9/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Gastrointestinal disorders Ascites	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Gastrointestinal disorders Bloating	22.2% 6/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Gastrointestinal disorders Constipation	37.0% 10/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Gastrointestinal disorders Diarrhea	66.7% 18/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Gastrointestinal disorders Dry mouth	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Gastrointestinal disorders Dyspepsia	7.4% 2/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Gastrointestinal disorders Gastroesophageal reflux disease	7.4% 2/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Gastrointestinal disorders Nausea	63.0% 17/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Gastrointestinal disorders Vomiting	48.1% 13/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
General disorders Chills	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
General disorders Edema limbs	18.5% 5/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
General disorders Fatigue	55.6% 15/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
General disorders Fever	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
General disorders Non-cardiac chest pain	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
General disorders Pain	11.1% 3/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Infections and infestations Infections and infestations - Other, specify	7.4% 2/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Infections and infestations Tooth infection	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Infections and infestations Sinusitis	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Infections and infestations Upper respiratory infection	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Infections and infestations Urinary tract infection	7.4% 2/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Investigations Alanine aminotransferase increased	33.3% 9/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Investigations Alkaline phosphatase increased	29.6% 8/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Investigations Aspartate aminotransferase increased	33.3% 9/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Investigations Creatinine increased	11.1% 3/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Investigations Investigations - Other, specify	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Investigations Neutrophil count decreased	7.4% 2/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Investigations Platelet count decreased	11.1% 3/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Investigations Weight loss	11.1% 3/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Investigations White blood cell decreased	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Metabolism and nutrition disorders Anorexia	14.8% 4/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Metabolism and nutrition disorders Dehydration	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Metabolism and nutrition disorders Hyperglycemia	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Metabolism and nutrition disorders Hyperkalemia	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Metabolism and nutrition disorders Hypoalbuminemia	14.8% 4/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Metabolism and nutrition disorders Hypocalcemia	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Metabolism and nutrition disorders Hypokalemia	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Metabolism and nutrition disorders Hypomagnesemia	22.2% 6/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Metabolism and nutrition disorders Hyponatremia	18.5% 5/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Musculoskeletal and connective tissue disorders Aarthralgia	11.1% 3/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Musculoskeletal and connective tissue disorders Arthritis	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Musculoskeletal and connective tissue disorders Back pain	14.8% 4/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Musculoskeletal and connective tissue disorders Bone pain	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Musculoskeletal and connective tissue disorders Chest wall pain	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder- Other, specify	11.1% 3/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Musculoskeletal and connective tissue disorders Myalgia	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Musculoskeletal and connective tissue disorders Neck pain	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Musculoskeletal and connective tissue disorders Pain in extremity	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Nervous system disorders Dizziness	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Nervous system disorders Dysgeusia	11.1% 3/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Nervous system disorders Headache	33.3% 9/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Nervous system disorders Nervous system disorders - Other, specify	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Nervous system disorders Peripheral sensory neuropathy	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Psychiatric disorders Anxiety	7.4% 2/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Psychiatric disorders Depression	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Renal and urinary disorders Hematuria	7.4% 2/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Renal and urinary disorders Proteinuria	14.8% 4/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Renal and urinary disorders Renal and urinary disorders - Other, specify	7.4% 2/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Renal and urinary disorders Urinary frequency	7.4% 2/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Renal and urinary disorders Urinary incontinence	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Renal and urinary disorders Urinary tract obstruction	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Reproductive system and breast disorders Vaginal dryness	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Reproductive system and breast disorders Vaginal pain	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Respiratory, thoracic and mediastinal disorders Atelectasis	7.4% 2/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Respiratory, thoracic and mediastinal disorders Cough	11.1% 3/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Respiratory, thoracic and mediastinal disorders Dyspnea	22.2% 6/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Respiratory, thoracic and mediastinal disorders Pleural effusion	11.1% 3/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Respiratory, thoracic and mediastinal disorders Wheezing	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Skin and subcutaneous tissue disorders Rash maculo-papular	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Skin and subcutaneous tissue disorders Skin ulceration	7.4% 2/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Vascular disorders Hypertension	25.9% 7/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.
Vascular disorders Hypotension	3.7% 1/27 • The study period during which all AEs and SAEs are collected began after informed consent is obtained and initiation of study treatment on Cycle 1, Day 1. It ended 30 days following the last administration of study treatment, or if the patient initiated treatment with a new anti-cancer therapy, or study discontinuation/termination; whichever was earlier.

Additional Information

Angeles Alvarez Secord

Duke University Medical Center

Phone: 919-684-3765

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place