Trial Outcomes & Findings for Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer (NCT NCT02228681)

NCT ID: NCT02228681

Last Updated: 2024-09-19

Results Overview

A confirmed complete or partial response as defined by RECIST 1.1 was considered a response. "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 74 participants
• Primary outcome timeframe: From date of randomization until the date of first documented progression or date of death , up to 3 years.
• Results posted on: 2024-09-19

Participant Flow

The study was activated on 02/19/2015 and closed to accrual on 04/18/2016. All patients underwent disease evaluation and were found to have measurable histologically confirmed advanced stage, persistent or recurrent endometrial carcinoma. After obtaining informed consent and verification of eligibility, patients were enrolled and treated.

Participant milestones

Measure	Everolimus and Letrozole Everolimus 10 mg daily plus letrozole 2.5 mg PO daily in a 28 day cycle.	Tamoxifen and Medroxyprogesterone Acetate Tamoxifen 20 mg PO bid days 1-28 plus medroxyprogesterone acetate 200 mg PO days 8-14 and 22-28 repeating in a 28 day cycle.
Overall Study STARTED	37	37
Overall Study COMPLETED	37	37
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer

Baseline characteristics by cohort

Measure	Everolimus and Letrozole n=37 Participants Everolimus 10 mg daily plus letrozole 2.5 mg PO daily in a 28 day cycle.	Tamoxifen and Medroxyprogesterone Acetate n=37 Participants Tamoxifen 20 mg PO bid days 1-28 plus medroxyprogesterone acetate 200 mg PO days 8-14 and 22-28 repeating in a 28 day cycle.	Total n=74 Participants Total of all reporting groups
Age, Continuous	63.3 years STANDARD_DEVIATION 9.1 • n=5 Participants	66.8 years STANDARD_DEVIATION 7.3 • n=7 Participants	65 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	37 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of randomization until the date of first documented progression or date of death , up to 3 years.

Population: Eligible and treated participants. One participant in arm II was not treated. Participant flow contains all eligible participants.

A confirmed complete or partial response as defined by RECIST 1.1 was considered a response. "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Measure	Everolimus and Letrozole n=37 Participants Everolimus 10 mg daily plus letrozole 2.5 mg PO daily in a 28 day cycle.	Tamoxifen and Medroxyprogesterone Acetate n=36 Participants Tamoxifen 20 mg PO bid days 1-28 plus medroxyprogesterone acetate 200 mg PO days 8-14 and 22-28 repeating in a 28 day cycle.
Frequency of Response	9 Number of participants	8 Number of participants

SECONDARY outcome

Timeframe: Tumor measurements were done at 8 and 16 weeks after initiating treatment and then every 12 weeks and compared with baseline measurements prior to treatment. Measurements are continued until disease progression is documented or death.

Population: Eligible Patients

Progression-free Survival is defined as the duration alive from study entry until progression is documented, or death; whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions' longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.

Outcome measures

Measure	Everolimus and Letrozole n=37 Participants Everolimus 10 mg daily plus letrozole 2.5 mg PO daily in a 28 day cycle.	Tamoxifen and Medroxyprogesterone Acetate n=37 Participants Tamoxifen 20 mg PO bid days 1-28 plus medroxyprogesterone acetate 200 mg PO days 8-14 and 22-28 repeating in a 28 day cycle.
Median Progression-free Survival	6.4 months Interval 3.8 to 17.7	3.7 months Interval 2.5 to 8.9

SECONDARY outcome

Timeframe: Assessed throughout the treatment period and for 30 days after discontinuation of treatment. Treatment continues until progression of disease.

Population: Eligible and Treated Patients

Maximum grade of physician assessed adverse events graded and categorized using Common Toxicity Criteria for Adverse Events (CTCAE) version 4

Outcome measures

Measure	Everolimus and Letrozole n=37 Participants Everolimus 10 mg daily plus letrozole 2.5 mg PO daily in a 28 day cycle.	Tamoxifen and Medroxyprogesterone Acetate n=36 Participants Tamoxifen 20 mg PO bid days 1-28 plus medroxyprogesterone acetate 200 mg PO days 8-14 and 22-28 repeating in a 28 day cycle.
Frequency and Severity of CTCAE (Common Toxicity Criteria for Adverse Events) Version 4 Grade 4	2 Participants	2 Participants
Frequency and Severity of CTCAE (Common Toxicity Criteria for Adverse Events) Version 4 Grade 2	6 Participants	14 Participants
Frequency and Severity of CTCAE (Common Toxicity Criteria for Adverse Events) Version 4 Grade 3	27 Participants	17 Participants
Frequency and Severity of CTCAE (Common Toxicity Criteria for Adverse Events) Version 4 Grade 1	2 Participants	2 Participants
Frequency and Severity of CTCAE (Common Toxicity Criteria for Adverse Events) Version 4 Grade 5	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Following treatment discontinuation, patients are followed quarterly for 2 years, semi-annually for 3 more years, annually thereafter.

Population: Eligible patients

Survival is defined as the duration alive from study entry until death.

Outcome measures

Measure	Everolimus and Letrozole n=37 Participants Everolimus 10 mg daily plus letrozole 2.5 mg PO daily in a 28 day cycle.	Tamoxifen and Medroxyprogesterone Acetate n=37 Participants Tamoxifen 20 mg PO bid days 1-28 plus medroxyprogesterone acetate 200 mg PO days 8-14 and 22-28 repeating in a 28 day cycle.
Median Survival	NA Months Interval 14.2 to No upper limit or median estimate can be provided as the median survival time has not been reached.	16.6 Months Interval 7.6 to No upper limit or median estimate can be provided as the median survival time has not been reached.

OTHER_PRE_SPECIFIED outcome

Timeframe: At study entry

To determine if relevant biomarkers correlate with response to treatment in each of the two arms. Unstained sections of tumor tissue will be used for hormone receptor (estrogen receptor-alpha, estrogen receptor-beta, progesterone receptor-A, progesterone receptor B and the G protein-coupled estrogen receptor, GPR-30) immunohistochemistry.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At study entry

To determine if relevant biomarkers correlate with response to treatment in each of the two arms. Unstained sections of tumor tissue will be used for mTOR pathway (including phosphorylated S6 ribosomal protein, PTEN, total and phosphorylated AKT, total and phosphorylated mTOR, and phospho-ERK1/2) immunohistochemistry

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At study entry

To determine if relevant biomarkers correlate with response to treatment in each of the two arms. Unstained sections of tumor tissue and DNA extracted from whole blood will be used for mutational analysis (including PTEN, PIK3CA, KRAS, and CTNNB1 (beta-catenin) performed using a sequencing panel assay.

Outcome measures

Outcome data not reported

Adverse Events

Everolimus and Letrozole

Serious events: 13 serious events

Other events: 37 other events

Deaths: 13 deaths

Tamoxifen and Medroxyprogesterone Acetate

Serious events: 10 serious events

Other events: 36 other events

Deaths: 20 deaths

Serious adverse events

Measure	Everolimus and Letrozole n=37 participants at risk Everolimus 10 mg daily plus letrozole 2.5 mg PO daily in a 28 day cycle.	Tamoxifen and Medroxyprogesterone Acetate n=36 participants at risk Tamoxifen 20 mg PO bid days 1-28 plus medroxyprogesterone acetate 200 mg PO days 8-14 and 22-28 repeating in a 28 day cycle.
Blood and lymphatic system disorders Anemia	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Cardiac disorders Pericardial Effusion	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Cardiac disorders Supraventricular Tachycardia	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Ascites	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Diarrhea	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Ileus	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Nausea	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
General disorders Fever	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Hepatobiliary disorders Cholecystitis	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Infections and infestations Kidney Infection	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Infections and infestations Lung Infection	8.1% 3/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Infections and infestations Sepsis	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Infections and infestations Urinary Tract Infection	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Investigations Creatinine Increased	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Musculoskeletal and connective tissue disorders Back Pain	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms Benign, Malignant and Unspecified (including cysts and polyps)	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Nervous system disorders Stroke	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Renal and urinary disorders Urinary Tract Obstruction	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Skin and subcutaneous tissue disorders Skin and Subcutaneous Tissue Disorder	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Vascular disorders Thromboembolic Event	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	8.3% 3/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.

Other adverse events

Measure	Everolimus and Letrozole n=37 participants at risk Everolimus 10 mg daily plus letrozole 2.5 mg PO daily in a 28 day cycle.	Tamoxifen and Medroxyprogesterone Acetate n=36 participants at risk Tamoxifen 20 mg PO bid days 1-28 plus medroxyprogesterone acetate 200 mg PO days 8-14 and 22-28 repeating in a 28 day cycle.
Blood and lymphatic system disorders Blood And Lymphatic System Disorders - Other	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Blood and lymphatic system disorders Anemia	67.6% 25/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	55.6% 20/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Cardiac disorders Atrial Fibrillation	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Cardiac disorders Supraventricular Tachycardia	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Cardiac disorders Palpitations	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Cardiac disorders Heart Failure	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Cardiac disorders Cardiac Disorders - Other	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Cardiac disorders Pericardial Effusion	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Cardiac disorders Sinus Tachycardia	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Ear and labyrinth disorders Vertigo	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Ear and labyrinth disorders Tinnitus	8.1% 3/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Ear and labyrinth disorders Hearing Impaired	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Endocrine disorders Hyperthyroidism	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Eye disorders Eye Disorders - Other	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Eye disorders Blurred Vision	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Eye disorders Vitreous Hemorrhage	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Dysphagia	10.8% 4/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	5.6% 2/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Dyspepsia	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	5.6% 2/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Dry Mouth	13.5% 5/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	8.3% 3/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Constipation	35.1% 13/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	33.3% 12/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Diarrhea	48.6% 18/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	19.4% 7/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Cheilitis	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Vomiting	24.3% 9/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	13.9% 5/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Bloating	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	5.6% 2/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Stomach Pain	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Salivary Duct Inflammation	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Rectal Mucositis	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Abdominal Pain	18.9% 7/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	25.0% 9/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Proctitis	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Rectal Hemorrhage	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Mucositis Oral	64.9% 24/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	11.1% 4/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Gastrointestinal Disorders - Other	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Oral Hemorrhage	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Ileus	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Gastrointestinal Pain	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Oral Pain	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Abdominal Distension	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Nausea	51.4% 19/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	33.3% 12/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Gastroesophageal Reflux Disease	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	8.3% 3/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Lip Pain	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Fecal Incontinence	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Hemorrhoids	8.1% 3/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Ascites	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	8.3% 3/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Toothache	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Gastrointestinal disorders Flatulence	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	5.6% 2/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
General disorders General Disorders And Administration Site Conditio	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
General disorders Pain	27.0% 10/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	16.7% 6/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
General disorders Malaise	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
General disorders Localized Edema	8.1% 3/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
General disorders Flu Like Symptoms	8.1% 3/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
General disorders Non-Cardiac Chest Pain	10.8% 4/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
General disorders Edema Limbs	40.5% 15/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	25.0% 9/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
General disorders Edema Face	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
General disorders Fatigue	59.5% 22/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	41.7% 15/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
General disorders Fever	10.8% 4/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	5.6% 2/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
General disorders Chills	10.8% 4/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Hepatobiliary disorders Portal Vein Thrombosis	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Hepatobiliary disorders Cholecystitis	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Infections and infestations Infections And Infestations - Other	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Infections and infestations Wound Infection	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Infections and infestations Upper Respiratory Infection	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Infections and infestations Tooth Infection	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Infections and infestations Vulval Infection	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Infections and infestations Skin Infection	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Infections and infestations Sinusitis	8.1% 3/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Infections and infestations Sepsis	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Infections and infestations Otitis Media	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Infections and infestations Papulopustular Rash	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Infections and infestations Nail Infection	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Infections and infestations Mucosal Infection	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Infections and infestations Lung Infection	13.5% 5/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Infections and infestations Kidney Infection	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Infections and infestations Eye Infection	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Infections and infestations Vaginal Infection	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Infections and infestations Urinary Tract Infection	16.2% 6/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Infections and infestations Bronchial Infection	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Injury, poisoning and procedural complications Wrist Fracture	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Injury, poisoning and procedural complications Fracture	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Injury, poisoning and procedural complications Fall	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	5.6% 2/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Injury, poisoning and procedural complications Burn	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Injury, poisoning and procedural complications Bruising	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Injury, poisoning and procedural complications Ankle Fracture	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Investigations Investigations - Other	10.8% 4/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Investigations Weight Loss	18.9% 7/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	13.9% 5/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Investigations Weight Gain	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	5.6% 2/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Investigations Platelet Count Decreased	40.5% 15/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	11.1% 4/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Investigations Lymphocyte Count Decreased	10.8% 4/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	5.6% 2/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Investigations Lipase Increased	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Investigations Inr Increased	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Investigations Creatinine Increased	16.2% 6/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	22.2% 8/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Investigations Cholesterol High	43.2% 16/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	8.3% 3/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Investigations Neutrophil Count Decreased	32.4% 12/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	8.3% 3/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Investigations Cd4 Lymphocytes Decreased	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Investigations Blood Bilirubin Increased	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Investigations White Blood Cell Decreased	45.9% 17/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	11.1% 4/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Investigations Aspartate Aminotransferase Increased	37.8% 14/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	22.2% 8/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Investigations Alkaline Phosphatase Increased	18.9% 7/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Investigations Alanine Aminotransferase Increased	29.7% 11/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	25.0% 9/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Metabolism and nutrition disorders Hypophosphatemia	13.5% 5/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	19.4% 7/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Metabolism and nutrition disorders Hyponatremia	10.8% 4/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	13.9% 5/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Metabolism and nutrition disorders Hypomagnesemia	21.6% 8/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Metabolism and nutrition disorders Hypokalemia	35.1% 13/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	22.2% 8/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Metabolism and nutrition disorders Hypoglycemia	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Metabolism and nutrition disorders Hypocalcemia	21.6% 8/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	25.0% 9/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Metabolism and nutrition disorders Hypoalbuminemia	43.2% 16/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	33.3% 12/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Metabolism and nutrition disorders Hypertriglyceridemia	54.1% 20/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	22.2% 8/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Metabolism and nutrition disorders Hypernatremia	13.5% 5/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Metabolism and nutrition disorders Hypermagnesemia	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	5.6% 2/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Metabolism and nutrition disorders Hyperkalemia	10.8% 4/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Metabolism and nutrition disorders Hyperglycemia	62.2% 23/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	30.6% 11/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Metabolism and nutrition disorders Hypercalcemia	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Metabolism and nutrition disorders Dehydration	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Metabolism and nutrition disorders Anorexia	35.1% 13/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	22.2% 8/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Musculoskeletal and connective tissue disorders Pain In Extremity	21.6% 8/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	8.3% 3/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Musculoskeletal and connective tissue disorders Osteoporosis	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Musculoskeletal and connective tissue disorders Neck Pain	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Musculoskeletal and connective tissue disorders Myalgia	21.6% 8/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	11.1% 4/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Musculoskeletal and connective tissue disorders Muscle Weakness Lower Limb	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	13.5% 5/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	8.3% 3/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Musculoskeletal and connective tissue disorders Trismus	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Musculoskeletal and connective tissue disorders Bone Pain	8.1% 3/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Musculoskeletal and connective tissue disorders Back Pain	18.9% 7/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	11.1% 4/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Musculoskeletal and connective tissue disorders Arthritis	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Musculoskeletal and connective tissue disorders Arthralgia	21.6% 8/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	13.9% 5/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Musculoskeletal and connective tissue disorders Musculoskeletal And Connective Tissue Disorder -	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms Benign, Malignant And Unspecified (Incl	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor Pain	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Nervous system disorders Nervous System Disorders - Other	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Nervous system disorders Tremor	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	5.6% 2/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Nervous system disorders Stroke	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Nervous system disorders Peripheral Sensory Neuropathy	18.9% 7/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	13.9% 5/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Nervous system disorders Paresthesia	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Nervous system disorders Memory Impairment	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Nervous system disorders Lethargy	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Nervous system disorders Headache	40.5% 15/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	8.3% 3/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Nervous system disorders Dysgeusia	21.6% 8/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Nervous system disorders Syncope	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Nervous system disorders Dizziness	10.8% 4/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	8.3% 3/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Psychiatric disorders Psychiatric Disorders - Other	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Psychiatric disorders Suicidal Ideation	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Psychiatric disorders Restlessness	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Psychiatric disorders Insomnia	24.3% 9/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	11.1% 4/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Psychiatric disorders Hallucinations	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Psychiatric disorders Depression	21.6% 8/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	11.1% 4/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Psychiatric disorders Delirium	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Psychiatric disorders Confusion	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Psychiatric disorders Anxiety	13.5% 5/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	11.1% 4/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Psychiatric disorders Agitation	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	5.6% 2/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Renal and urinary disorders Renal And Urinary Disorders - Other	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	5.6% 2/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Renal and urinary disorders Urinary Urgency	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Renal and urinary disorders Urinary Tract Obstruction	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	5.6% 2/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Renal and urinary disorders Urinary Retention	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Renal and urinary disorders Urinary Incontinence	10.8% 4/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Renal and urinary disorders Urinary Tract Pain	13.5% 5/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	8.3% 3/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Renal and urinary disorders Urinary Frequency	16.2% 6/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	5.6% 2/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Renal and urinary disorders Renal Calculi	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Renal and urinary disorders Proteinuria	18.9% 7/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	13.9% 5/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Renal and urinary disorders Hematuria	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	5.6% 2/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	5.6% 2/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Reproductive system and breast disorders Reproductive System And Breast Disorders - Other	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Reproductive system and breast disorders Vaginal Pain	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Reproductive system and breast disorders Vaginal Hemorrhage	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	16.7% 6/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Reproductive system and breast disorders Perineal Pain	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Reproductive system and breast disorders Pelvic Pain	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	8.3% 3/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Reproductive system and breast disorders Vaginal Discharge	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	8.3% 3/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Reproductive system and breast disorders Breast Pain	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic And Mediastinal Disorders -	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Respiratory, thoracic and mediastinal disorders Sore Throat	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Respiratory, thoracic and mediastinal disorders Postnasal Drip	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	5.6% 2/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Respiratory, thoracic and mediastinal disorders Pneumonitis	8.1% 3/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Respiratory, thoracic and mediastinal disorders Productive Cough	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Respiratory, thoracic and mediastinal disorders Epistaxis	29.7% 11/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Respiratory, thoracic and mediastinal disorders Dyspnea	40.5% 15/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	30.6% 11/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Respiratory, thoracic and mediastinal disorders Cough	48.6% 18/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	19.4% 7/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	16.2% 6/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	5.6% 2/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Skin and subcutaneous tissue disorders Skin And Subcutaneous Tissue Disorders - Other	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	5.6% 2/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Skin and subcutaneous tissue disorders Rash Acneiform	8.1% 3/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Skin and subcutaneous tissue disorders Pruritus	18.9% 7/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Skin and subcutaneous tissue disorders Periorbital Edema	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Skin and subcutaneous tissue disorders Pain Of Skin	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	21.6% 8/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	8.3% 3/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Skin and subcutaneous tissue disorders Nail Ridging	8.1% 3/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Skin and subcutaneous tissue disorders Nail Discoloration	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Skin and subcutaneous tissue disorders Dry Skin	10.8% 4/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	8.3% 3/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Skin and subcutaneous tissue disorders Alopecia	21.6% 8/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	8.3% 3/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Vascular disorders Thromboembolic Event	2.7% 1/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	13.9% 5/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Vascular disorders Lymphedema	5.4% 2/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	0.00% 0/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Vascular disorders Hypertension	35.1% 13/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	22.2% 8/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Vascular disorders Hot Flashes	24.3% 9/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	22.2% 8/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
Vascular disorders Flushing	0.00% 0/37 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.	2.8% 1/36 • up to 30 days after the last cycle. Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.

Additional Information

Linda Gedeon for Virginia Filiaci, PhD

GOG Foundation

Phone: 716-845-1169

Email: lgedeon@gogstats.org

Results disclosure agreements

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

Restriction type: LTE60