Trial Outcomes & Findings for Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer (NCT NCT02668666)

Last Updated: 2026-01-20

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. PFS is defined as time from registration until disease progression met by RECIST 1.1 or death from any cause.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

49 participants

Primary outcome timeframe

Time of treatment start until the criteria for disease progression or death. Up to a maximum of 61 months.

Results posted on

2026-01-20

Participant Flow

Participant milestones

Participant milestones
Measure	Investigational Treatment Subjects will be enrolled to determine progression-free survival (PFS) in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies. Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28. Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously). Palbociclib: Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28. Tamoxifen: Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).
Overall Study STARTED	49
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Investigational Treatment n=49 Participants Subjects will be enrolled to determine progression-free survival (PFS) in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies. Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28. Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously). Palbociclib: Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28. Tamoxifen: Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).
Age, Continuous	60 years n=37 Participants
Sex: Female, Male Female	49 Participants n=37 Participants
Sex: Female, Male Male	0 Participants n=37 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=37 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=37 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=37 Participants
Race (NIH/OMB) Asian	1 Participants n=37 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants
Race (NIH/OMB) Black or African American	11 Participants n=37 Participants
Race (NIH/OMB) White	33 Participants n=37 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=37 Participants
Region of Enrollment United States	49 participants n=37 Participants
Menopausal Status Post-menopausal	40 Participants n=37 Participants
Menopausal Status Pre-menopausal	9 Participants n=37 Participants
ECOG Performance ECOG = 0	33 Participants n=37 Participants
ECOG Performance ECOG = 1	15 Participants n=37 Participants
ECOG Performance ECOG = 2	1 Participants n=37 Participants

PRIMARY outcome

Timeframe: Time of treatment start until the criteria for disease progression or death. Up to a maximum of 61 months.

Population: Out of 49 subjects, 41 subjects were evaluable for PFS per RECIST 1.1 criteria.

Outcome measures

Outcome measures
Measure	Investigational Treatment n=41 Participants Subjects will be enrolled to determine progression-free survival (PFS) in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies. Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28. Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously). Palbociclib: Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28. Tamoxifen: Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).
Progression Free Survival (PFS) Per RECIST 1.1	9.13 Months Interval 5.91 to 18.96

SECONDARY outcome

Timeframe: Adverse events (AEs) had been recorded from the time of consent until 30 days after discontinuation of study drug(s), up to a maximum of 56 months.

Number of subjects experienced toxicity and tolerability of palbociclib and tamoxifen combination therapy, per Common Terminology Criteria for Adverse Events (CTCAE) v4.

Outcome measures

Outcome measures
Measure	Investigational Treatment n=49 Participants Subjects will be enrolled to determine progression-free survival (PFS) in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies. Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28. Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously). Palbociclib: Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28. Tamoxifen: Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).
Adverse Events	49 Participants

SECONDARY outcome

Timeframe: Up to a maximum of 61 months.

Population: Out of 49 subjects, two subjects did not meet the evaluable criteria, and therefore excluded from the efficacy analysis.

Outcome measures

Outcome measures
Measure	Investigational Treatment n=47 Participants Subjects will be enrolled to determine progression-free survival (PFS) in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies. Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28. Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously). Palbociclib: Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28. Tamoxifen: Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).
Objective Response Rates (ORR)	30 Percentage of participants

SECONDARY outcome

Timeframe: Up to a maximum of 61 months.

Population: Out of 49 subjects, two subjects did not meet the evaluable criteria, and therefore excluded from the efficacy analysis.

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; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. Per MD Anderson (MDA) criteria for bone only disease: CR, Complete sclerotic fill-in of lytic lesions on XR or CT and Normalization of signal intensity on MRI; PR, decrease of ≥ 50% in the sum of the perpendicular measurements of any lesion on XR, CT, or MRI; PD \> 25% increase in in the sum of measurable lesions or new bone metastases; SD, not meet criteria for CR/PR/PD. Clinical Benefit = CR +PR+SD lasting 24 weeks or longer.

Outcome measures

Outcome measures
Measure	Investigational Treatment n=47 Participants Subjects will be enrolled to determine progression-free survival (PFS) in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies. Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28. Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously). Palbociclib: Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28. Tamoxifen: Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).
Clinical Benefit Rate (CBR)	64 Percentage of participants

SECONDARY outcome

Timeframe: 2 years

To determine the percentage of overall survival at 2 years from the initiation of treatment. Overall survival is defined as the time from treatment start until death or date of last contact.

Outcome measures

Outcome measures
Measure	Investigational Treatment n=49 Participants Subjects will be enrolled to determine progression-free survival (PFS) in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies. Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28. Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously). Palbociclib: Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28. Tamoxifen: Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).
Overall Survival (OS)	75.63 Percentage of participants Interval 60.28 to 85.72

Adverse Events

Investigational Treatment

Serious events: 16 serious events

Other events: 49 other events

Deaths: 16 deaths

Serious adverse events

Serious adverse events
Measure	Investigational Treatment n=49 participants at risk Subjects will be enrolled to determine progression-free survival (PFS) in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies. Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28. Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously). Palbociclib: Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28. Tamoxifen: Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).
GASTROINTESTINAL DISORDERS ABDOMINAL PAIN	4.1% 2/49 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS BACK PAIN	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS BRONCHOSPASM	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GASTROINTESTINAL DISORDERS COLONIC PERFORATION	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS DYSPNEA	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INFECTIONS AND INFESTATIONS ENTEROCOLITIS INFECTIOUS	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GASTROINTESTINAL DISORDERS ESOPHAGITIS	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS FLANK PAIN	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS FRACTURE	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
HEPATOBILIARY DISORDERS GALLBLADDER OBSTRUCTION	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
HEPATOBILIARY DISORDERS GALLBLADDER PERFORATION	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GASTROINTESTINAL DISORDERS GASTROINTESTINAL DISORDERS - OTHER, SPECIFY	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
VASCULAR DISORDERS HYPOTENSION	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
VASCULAR DISORDERS THROMBOEMBOLIC EVENT	8.2% 4/49 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INFECTIONS AND INFESTATIONS URINARY TRACT INFECTION	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
Cardiac disorders CARDIAC ARREST	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.

Other adverse events

Other adverse events
Measure	Investigational Treatment n=49 participants at risk Subjects will be enrolled to determine progression-free survival (PFS) in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies. Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28. Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously). Palbociclib: Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28. Tamoxifen: Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).
SKIN AND SUBCUTANEOUS TISSUE DISORDERS ALOPECIA	22.4% 11/49 • Number of events 11 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GASTROINTESTINAL DISORDERS ABDOMINAL PAIN	22.4% 11/49 • Number of events 18 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INVESTIGATIONS ALANINE AMINOTRANSFERASE INCREASED	4.1% 2/49 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INVESTIGATIONS ALKALINE PHOSPHATASE INCREASED	20.4% 10/49 • Number of events 14 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS ALLERGIC RHINITIS	6.1% 3/49 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
NERVOUS SYSTEM DISORDERS AMNESIA	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
BLOOD AND LYMPHATIC SYSTEM DISORDERS ANEMIA	44.9% 22/49 • Number of events 83 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
METABOLISM AND NUTRITION DISORDERS ANOREXIA	24.5% 12/49 • Number of events 14 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
PSYCHIATRIC DISORDERS ANXIETY	8.2% 4/49 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS ARTHRALGIA	10.2% 5/49 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS ARTHRITIS	8.2% 4/49 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INVESTIGATIONS ASPARTATE AMINOTRANSFERASE INCREASED	8.2% 4/49 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS BACK PAIN	38.8% 19/49 • Number of events 29 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INFECTIONS AND INFESTATIONS BLADDER INFECTION	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GASTROINTESTINAL DISORDERS BLOATING	4.1% 2/49 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
BLOOD AND LYMPHATIC SYSTEM DISORDERS BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INVESTIGATIONS BLOOD BILIRUBIN INCREASED	4.1% 2/49 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
EYE DISORDERS BLURRED VISION	4.1% 2/49 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS BONE PAIN	16.3% 8/49 • Number of events 12 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
REPRODUCTIVE SYSTEM AND BREAST DISORDERS BREAST PAIN	6.1% 3/49 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INFECTIONS AND INFESTATIONS BRONCHIAL INFECTION	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS BRUISING	8.2% 4/49 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS BULLOUS DERMATITIS	4.1% 2/49 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS BUTTOCK PAIN	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS CHILLS	16.3% 8/49 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INVESTIGATIONS CHOLESTEROL HIGH	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RENAL AND URINARY DISORDERS CHRONIC KIDNEY DISEASE	2.0% 1/49 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GASTROINTESTINAL DISORDERS COLITIS	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
PSYCHIATRIC DISORDERS CONFUSION	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
CONGENITAL, FAMILIAL AND GENETIC DISORDERS CONGENITAL, FAMILIAL AND GENETIC DISORDERS - OTHER, SPECIFY	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GASTROINTESTINAL DISORDERS CONSTIPATION	22.4% 11/49 • Number of events 15 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS COUGH	28.6% 14/49 • Number of events 24 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INVESTIGATIONS CREATININE INCREASED	10.2% 5/49 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
METABOLISM AND NUTRITION DISORDERS DEHYDRATION	6.1% 3/49 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
PSYCHIATRIC DISORDERS DEPRESSION	12.2% 6/49 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS DERMATITIS RADIATION	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GASTROINTESTINAL DISORDERS DIARRHEA	30.6% 15/49 • Number of events 23 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
NERVOUS SYSTEM DISORDERS DIZZINESS	24.5% 12/49 • Number of events 13 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
EYE DISORDERS DRY EYE	8.2% 4/49 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GASTROINTESTINAL DISORDERS DRY MOUTH	4.1% 2/49 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS DRY SKIN	8.2% 4/49 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
NERVOUS SYSTEM DISORDERS DYSGEUSIA	8.2% 4/49 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GASTROINTESTINAL DISORDERS DYSPEPSIA	10.2% 5/49 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
NERVOUS SYSTEM DISORDERS DYSPHASIA	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS DYSPNEA	22.4% 11/49 • Number of events 17 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
EAR AND LABYRINTH DISORDERS EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
EAR AND LABYRINTH DISORDERS EAR PAIN	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS EDEMA FACE	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS EDEMA LIMBS	20.4% 10/49 • Number of events 16 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
ENDOCRINE DISORDERS ENDOCRINE DISORDERS - OTHER, SPECIFY	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INFECTIONS AND INFESTATIONS ENTEROCOLITIS INFECTIOUS	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS EPISTAXIS	12.2% 6/49 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GASTROINTESTINAL DISORDERS ESOPHAGEAL PAIN	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
EYE DISORDERS EYE DISORDERS - OTHER, SPECIFY	6.1% 3/49 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
NERVOUS SYSTEM DISORDERS FACIAL NERVE DISORDER	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS FACIAL PAIN	4.1% 2/49 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS FALL	8.2% 4/49 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS FATIGUE	65.3% 32/49 • Number of events 59 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS FEVER	6.1% 3/49 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS FLANK PAIN	4.1% 2/49 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
EYE DISORDERS FLOATERS	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS FLU LIKE SYMPTOMS	8.2% 4/49 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS FRACTURE	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GASTROINTESTINAL DISORDERS GASTROESOPHAGEAL REFLUX DISEASE	10.2% 5/49 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GASTROINTESTINAL DISORDERS GASTROINTESTINAL DISORDERS - OTHER, SPECIFY	8.2% 4/49 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY	8.2% 4/49 • Number of events 10 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS GENERALIZED MUSCLE WEAKNESS	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
EYE DISORDERS GLAUCOMA	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
NERVOUS SYSTEM DISORDERS HEADACHE	26.5% 13/49 • Number of events 16 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
EAR AND LABYRINTH DISORDERS HEARING IMPAIRED	2.0% 1/49 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
VASCULAR DISORDERS HEMATOMA	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INVESTIGATIONS HEMOGLOBIN INCREASED	2.0% 1/49 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GASTROINTESTINAL DISORDERS HEMORRHOIDS	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS HIP FRACTURE	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS HOARSENESS	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
VASCULAR DISORDERS HOT FLASHES	30.6% 15/49 • Number of events 36 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
METABOLISM AND NUTRITION DISORDERS HYPERCALCEMIA	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
METABOLISM AND NUTRITION DISORDERS HYPERGLYCEMIA	10.2% 5/49 • Number of events 26 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
METABOLISM AND NUTRITION DISORDERS HYPERKALEMIA	4.1% 2/49 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
METABOLISM AND NUTRITION DISORDERS HYPERMAGNESEMIA	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
VASCULAR DISORDERS HYPERTENSION	36.7% 18/49 • Number of events 31 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
METABOLISM AND NUTRITION DISORDERS HYPOALBUMINEMIA	16.3% 8/49 • Number of events 15 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
METABOLISM AND NUTRITION DISORDERS HYPOCALCEMIA	22.4% 11/49 • Number of events 20 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
METABOLISM AND NUTRITION DISORDERS HYPOKALEMIA	18.4% 9/49 • Number of events 18 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
METABOLISM AND NUTRITION DISORDERS HYPONATREMIA	18.4% 9/49 • Number of events 19 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
ENDOCRINE DISORDERS HYPOTHYROIDISM	10.2% 5/49 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS HYPOXIA	2.0% 1/49 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INFECTIONS AND INFESTATIONS INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	14.3% 7/49 • Number of events 11 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
PSYCHIATRIC DISORDERS INSOMNIA	8.2% 4/49 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INVESTIGATIONS INVESTIGATIONS - OTHER, SPECIFY	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
REPRODUCTIVE SYSTEM AND BREAST DISORDERS IRREGULAR MENSTRUATION	2.0% 1/49 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS IRRITABILITY	6.1% 3/49 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS JOINT RANGE OF MOTION DECREASED	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS LARYNGEAL INFLAMMATION	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
BLOOD AND LYMPHATIC SYSTEM DISORDERS LEUKOCYTOSIS	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INVESTIGATIONS LIPASE INCREASED	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS LOCALIZED EDEMA	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INFECTIONS AND INFESTATIONS LUNG INFECTION	4.1% 2/49 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
VASCULAR DISORDERS LYMPHEDEMA	10.2% 5/49 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INVESTIGATIONS LYMPHOCYTE COUNT DECREASED	24.5% 12/49 • Number of events 38 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
NERVOUS SYSTEM DISORDERS MEMORY IMPAIRMENT	8.2% 4/49 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
METABOLISM AND NUTRITION DISORDERS METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY	10.2% 5/49 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GASTROINTESTINAL DISORDERS MUCOSITIS ORAL	12.2% 6/49 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS MUSCLE WEAKNESS LOWER LIMB	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY	26.5% 13/49 • Number of events 16 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS MYALGIA	6.1% 3/49 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INFECTIONS AND INFESTATIONS NAIL INFECTION	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS NAIL LOSS	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS NAIL RIDGING	4.1% 2/49 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS NASAL CONGESTION	8.2% 4/49 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GASTROINTESTINAL DISORDERS NAUSEA	53.1% 26/49 • Number of events 44 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS NECK PAIN	6.1% 3/49 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY	4.1% 2/49 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
NERVOUS SYSTEM DISORDERS NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY	6.1% 3/49 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INVESTIGATIONS NEUTROPHIL COUNT DECREASED	71.4% 35/49 • Number of events 234 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS NON-CARDIAC CHEST PAIN	6.1% 3/49 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GASTROINTESTINAL DISORDERS ORAL DYSESTHESIA	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GASTROINTESTINAL DISORDERS ORAL PAIN	8.2% 4/49 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS OSTEOPOROSIS	6.1% 3/49 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS PAIN	22.4% 11/49 • Number of events 18 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS PAIN IN EXTREMITY	40.8% 20/49 • Number of events 39 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS PAIN OF SKIN	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INFECTIONS AND INFESTATIONS PAPULOPUSTULAR RASH	2.0% 1/49 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
NERVOUS SYSTEM DISORDERS PARESTHESIA	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INFECTIONS AND INFESTATIONS PARONYCHIA	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
REPRODUCTIVE SYSTEM AND BREAST DISORDERS PERINEAL PAIN	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
NERVOUS SYSTEM DISORDERS PERIPHERAL SENSORY NEUROPATHY	6.1% 3/49 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INVESTIGATIONS PLATELET COUNT DECREASED	40.8% 20/49 • Number of events 44 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PLEURAL EFFUSION	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PNEUMONITIS	4.1% 2/49 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS POSTNASAL DRIP	6.1% 3/49 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS PRODUCTIVE COUGH	8.2% 4/49 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS PRURITUS	12.2% 6/49 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INJURY, POISONING AND PROCEDURAL COMPLICATIONS RADIATION RECALL REACTION (DERMATOLOGIC)	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS RASH ACNEIFORM	4.1% 2/49 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS RASH MACULO-PAPULAR	8.2% 4/49 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RENAL AND URINARY DISORDERS RENAL AND URINARY DISORDERS - OTHER, SPECIFY	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
REPRODUCTIVE SYSTEM AND BREAST DISORDERS REPRODUCTIVE SYSTEM AND BREAST DISORDERS - OTHER, SPECIFY	6.1% 3/49 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY	4.1% 2/49 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INFECTIONS AND INFESTATIONS RHINITIS INFECTIVE	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS SCALP PAIN	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS SCOLIOSIS	4.1% 2/49 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
CARDIAC DISORDERS SINUS TACHYCARDIA	4.1% 2/49 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INFECTIONS AND INFESTATIONS SINUSITIS	2.0% 1/49 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY	18.4% 9/49 • Number of events 14 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INFECTIONS AND INFESTATIONS SKIN INFECTION	8.2% 4/49 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS SKIN ULCERATION	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS SNEEZING	4.1% 2/49 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS SORE THROAT	14.3% 7/49 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
VASCULAR DISORDERS THROMBOEMBOLIC EVENT	8.2% 4/49 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
EAR AND LABYRINTH DISORDERS TINNITUS	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INFECTIONS AND INFESTATIONS TOOTH INFECTION	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GASTROINTESTINAL DISORDERS TOOTHACHE	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
NERVOUS SYSTEM DISORDERS TREMOR	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INFECTIONS AND INFESTATIONS UPPER RESPIRATORY INFECTION	18.4% 9/49 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RENAL AND URINARY DISORDERS URINARY FISTULA	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RENAL AND URINARY DISORDERS URINARY FREQUENCY	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RENAL AND URINARY DISORDERS URINARY INCONTINENCE	2.0% 1/49 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INFECTIONS AND INFESTATIONS URINARY TRACT INFECTION	12.2% 6/49 • Number of events 12 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RENAL AND URINARY DISORDERS URINARY URGENCY	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
RENAL AND URINARY DISORDERS URINE DISCOLORATION	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS URTICARIA	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
REPRODUCTIVE SYSTEM AND BREAST DISORDERS VAGINAL DISCHARGE	4.1% 2/49 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
REPRODUCTIVE SYSTEM AND BREAST DISORDERS VAGINAL DRYNESS	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INFECTIONS AND INFESTATIONS VAGINAL INFECTION	6.1% 3/49 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
EAR AND LABYRINTH DISORDERS VERTIGO	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
EAR AND LABYRINTH DISORDERS VESTIBULAR DISORDER	2.0% 1/49 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
GASTROINTESTINAL DISORDERS VOMITING	24.5% 12/49 • Number of events 22 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INVESTIGATIONS WEIGHT GAIN	12.2% 6/49 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INVESTIGATIONS WEIGHT LOSS	14.3% 7/49 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.
INVESTIGATIONS WHITE BLOOD CELL DECREASED	65.3% 32/49 • Number of events 169 • All-Cause Mortality was monitored up to a maximum of 69 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 56 months.

Additional Information

Fauzia Sharmin

Hoosier Cancer Research Network

Phone: 317-921-2050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place