Trial Outcomes & Findings for RAD001 for Patients With Radioiodine Refractory Thyroid Cancer (NCT NCT00936858)
NCT ID: NCT00936858
Last Updated: 2021-10-22
Results Overview
Progression free survival (PFS) is defined as the time from start of treatment to disease progression or death from any cause as estimated by Kaplan Meier methods. Progression is measured using RECIST 1.1 criteria, defined as at least a 20% increase in size in target lesion and/or unequivocal progression of non-target lesions and/or appearance of new lesions. Patients who have not progressed and are alive are censored at the date the patient is known to be progression-free.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Every 2 months for first 24 months, then every 3 months from >24 to 60 months; up to 48 months.
Results posted on
2021-10-22
Participant Flow
July 2009 to August 2013
Participant milestones
| Measure |
RAD001 Group
RAD001 will be administered orally as once daily dose of 10 mg (one 10mg tablet or two 5mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.
RAD001: Taken orally once a day in the morning
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
Participants With Medullary Thyroid Cancer
|
10
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
50
|
Reasons for withdrawal
| Measure |
RAD001 Group
RAD001 will be administered orally as once daily dose of 10 mg (one 10mg tablet or two 5mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.
RAD001: Taken orally once a day in the morning
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Progression
|
29
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Physician Decision
|
7
|
|
Overall Study
Still on protocol treatment/ No documentation to say off protocol treatment
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
RAD001 for Patients With Radioiodine Refractory Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Arm A
n=50 Participants
RAD001 will be administered orally as once daily dose of 10 mg (one 10mg tablet or two 5mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.
RAD001: Taken orally once a day in the morning
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Subtype
Medullary
|
10 Participants
n=5 Participants
|
|
Subtype
Differentiated
|
33 Participants
n=5 Participants
|
|
Subtype
Anaplastic
|
7 Participants
n=5 Participants
|
|
Previous Therapies
Tyrosine Kinase Inhibitors · Yes
|
22 Participants
n=5 Participants
|
|
Previous Therapies
Tyrosine Kinase Inhibitors · No
|
28 Participants
n=5 Participants
|
|
Previous Therapies
Surgery · Yes
|
44 Participants
n=5 Participants
|
|
Previous Therapies
Surgery · No
|
6 Participants
n=5 Participants
|
|
Previous Therapies
Radioactive Iodine · Yes
|
31 Participants
n=5 Participants
|
|
Previous Therapies
Radioactive Iodine · No
|
19 Participants
n=5 Participants
|
|
Previous Therapies
External Beam Radiotherapy · Yes
|
30 Participants
n=5 Participants
|
|
Previous Therapies
External Beam Radiotherapy · No
|
20 Participants
n=5 Participants
|
|
ECOG Performance Status
0 - Fully Active
|
32 Participants
n=5 Participants
|
|
ECOG Performance Status
1 - Restricted
|
14 Participants
n=5 Participants
|
|
ECOG Performance Status
2- Ambulatory and Capable of Self Care
|
4 Participants
n=5 Participants
|
|
Site of Distant Metastasis
None · Yes
|
1 Participants
n=5 Participants
|
|
Site of Distant Metastasis
None · No (Not a Metastatic Site)
|
49 Participants
n=5 Participants
|
|
Site of Distant Metastasis
Bone · Yes
|
21 Participants
n=5 Participants
|
|
Site of Distant Metastasis
Bone · No (Not a Metastatic Site)
|
29 Participants
n=5 Participants
|
|
Site of Distant Metastasis
Lung · Yes
|
33 Participants
n=5 Participants
|
|
Site of Distant Metastasis
Lung · No (Not a Metastatic Site)
|
17 Participants
n=5 Participants
|
|
Site of Distant Metastasis
Liver · Yes
|
14 Participants
n=5 Participants
|
|
Site of Distant Metastasis
Liver · No (Not a Metastatic Site)
|
36 Participants
n=5 Participants
|
|
Site of Distant Metastasis
Lymph Nodes · Yes
|
26 Participants
n=5 Participants
|
|
Site of Distant Metastasis
Lymph Nodes · No (Not a Metastatic Site)
|
24 Participants
n=5 Participants
|
|
Site of Distant Metastasis
Other · Yes
|
12 Participants
n=5 Participants
|
|
Site of Distant Metastasis
Other · No (Not a Metastatic Site)
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 2 months for first 24 months, then every 3 months from >24 to 60 months; up to 48 months.Progression free survival (PFS) is defined as the time from start of treatment to disease progression or death from any cause as estimated by Kaplan Meier methods. Progression is measured using RECIST 1.1 criteria, defined as at least a 20% increase in size in target lesion and/or unequivocal progression of non-target lesions and/or appearance of new lesions. Patients who have not progressed and are alive are censored at the date the patient is known to be progression-free.
Outcome measures
| Measure |
Arm A
n=50 Participants
RAD001 will be administered orally as once daily dose of 10 mg (one 10mg tablet or two 5mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.
RAD001: Taken orally once a day in the morning
|
|---|---|
|
Median Progression Free Survival
|
12.5 months
Interval 7.2 to 17.5
|
SECONDARY outcome
Timeframe: Every 2 months for first 24 months, then every 3 months from >24 to 60 months; up to 48 months.The objective response rate is the proportion of participants achieving complete response (CR) or partial response (PR) on treatment based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria. PR or better is achieved if the following are true: Target Lesions: -At least a 30% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Non-target Lesions: No progression. No appearance new lesions or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. Bone Lesions: -\>50% increase in lesions. -No new lesions.
Outcome measures
| Measure |
Arm A
n=50 Participants
RAD001 will be administered orally as once daily dose of 10 mg (one 10mg tablet or two 5mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.
RAD001: Taken orally once a day in the morning
|
|---|---|
|
Objective Response Rate
|
6 percentage of participants
Interval 0.0 to 12.6
|
SECONDARY outcome
Timeframe: Every 2 months for first 24 months, then every 3 months from >24 to 60 months; up to 5 years post study registration.Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive.
Outcome measures
| Measure |
Arm A
n=50 Participants
RAD001 will be administered orally as once daily dose of 10 mg (one 10mg tablet or two 5mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.
RAD001: Taken orally once a day in the morning
|
|---|---|
|
Median Overall Survival
|
32.7 months
Interval 18.7 to 61.3
|
SECONDARY outcome
Timeframe: Measured at baseline and then again at cycle 8 (8 months).Population: Only 8 of the 10 participants with Medullary Thyroid Cancer filled out both questionnaires (one at baseline and one at cycle 8).
The M. D. Anderson Symptom Inventory (MDASI) questionnaire was used to assess quality of life. Questions 1 to 19 were scored. Each of the 19 questions have a response range of 0 - 10, where 0 represents "not present" and 10 represents "as bad as you can imagine". The 19 responses are averaged together to create a mean score, with a lower score indicating a better quality of life. All questionnaire mean scores at each timepoint are averaged together to give a mean score at that timepoint (baseline and week 8) The mean change in quality of life is calculated by subtracting the baseline mean score from the week 8 mean score.
Outcome measures
| Measure |
Arm A
n=8 Participants
RAD001 will be administered orally as once daily dose of 10 mg (one 10mg tablet or two 5mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.
RAD001: Taken orally once a day in the morning
|
|---|---|
|
Mean Change in Quality of Life [Medullary Thyroid Cancer Population Only]
|
-0.0621 mean change in score on the MDASI scale
Standard Deviation 0.992
|
Adverse Events
Arm A
Serious events: 36 serious events
Other events: 50 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Arm A
n=50 participants at risk
RAD001 will be administered orally as once daily dose of 10 mg (one 10mg tablet or two 5mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.
RAD001: Taken orally once a day in the morning
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
6.0%
3/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Blood and lymphatic system disorders
Hematologic-other
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
10.0%
5/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
8.0%
4/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Nausea
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
GI-other
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
General disorders
Fatigue
|
14.0%
7/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
General disorders
Fever w/o neutropenia
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
General disorders
Constitutional, other
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Infections and infestations
Infection w/ gr3-4 neut, skin
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Infections and infestations
Infection Gr0-2 neut, lung
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Infections and infestations
Infection Gr0-2 neut, pharynx
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Infections and infestations
Infection Gr0-2 neut, upper airway
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Infections and infestations
Infection-other
|
12.0%
6/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
Lymphopenia
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
Neutrophils
|
8.0%
4/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
Platelets
|
6.0%
3/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
Weight loss
|
10.0%
5/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
ALT, SGPT
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
Amylase
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
Hypercholesterolemia
|
6.0%
3/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
Creatinine
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
Lipase
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Metabolism and nutrition disorders
Anorexia
|
8.0%
4/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
5/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.0%
3/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Nervous system disorders
Taste disturbance
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Nervous system disorders
Neurologic-other
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Nervous system disorders
Head/headache
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Psychiatric disorders
Insomnia
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
Other adverse events
| Measure |
Arm A
n=50 participants at risk
RAD001 will be administered orally as once daily dose of 10 mg (one 10mg tablet or two 5mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.
RAD001: Taken orally once a day in the morning
|
|---|---|
|
Cardiac disorders
Cardiac-ischemia
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Tootheache
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Nervous system disorders
Dysgeunsia
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Vascular disorders
Vascular Disorder - Other
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Infections and infestations
Infection Gr0-2 neut, upper airway
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Infections and infestations
Infection w/ unk ANC lung
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Infections and infestations
Infection w/ unk ANC upper airway NOS
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Infections and infestations
Infection w/ unk ANC urinary tract NOS
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.0%
8/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Nervous system disorders
Speech impairment
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
56.0%
28/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Blood and lymphatic system disorders
Hemolysis
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Blood and lymphatic system disorders
Hematologic-other
|
14.0%
7/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Blood and lymphatic system disorders
Lymphatics-other
|
6.0%
3/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Cardiac disorders
Sinus tachycardia
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Cardiac disorders
Arrhythmia-other
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Ear and labyrinth disorders
Tinnitus
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Ear and labyrinth disorders
Middle ear, pain
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Eye disorders
Dry eye syndrome
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Eye disorders
Ocular surface disease
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Eye disorders
Vision-blurred
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Eye disorders
Vision-photophobia
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Eye disorders
Tearing
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Eye disorders
Ocular-other
|
6.0%
3/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Chelitis
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Constipation
|
10.0%
5/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
54.0%
27/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
10.0%
5/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Dry mouth
|
34.0%
17/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Dysphagia
|
14.0%
7/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Flatulence
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Dyspepsia
|
12.0%
6/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Ileus
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Incontinence, anal
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
50.0%
25/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
18.0%
9/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Nausea
|
26.0%
13/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Salivary
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Ulcer, gastric
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Vomiting
|
22.0%
11/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
GI-other
|
24.0%
12/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Anus, hemorrhage
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Oral cavity, hemorrhage
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Rectum, hemorrhage
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Abdomen, pain
|
10.0%
5/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Dental/teeth/peridontal, pain
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Oral cavity, pain
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Gastrointestinal disorders
Oral gums, pain
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
General disorders
Fatigue
|
80.0%
40/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
General disorders
Fever w/o neutropenia
|
22.0%
11/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
General disorders
Constitutional, other
|
6.0%
3/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
General disorders
Edema head and neck
|
8.0%
4/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
General disorders
Edema limb
|
44.0%
22/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
General disorders
Chest/thoracic pain NOS
|
8.0%
4/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
General disorders
Face, pain
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
General disorders
Pain NOS
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
General disorders
Pain-other
|
38.0%
19/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
General disorders
Flu-like syndrome
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
General disorders
Syndromes-other
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Hepatobiliary disorders
Hepatic-other
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Hepatobiliary disorders
Liver, pain
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Immune system disorders
Allergic reaction
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Immune system disorders
Allergy-other
|
6.0%
3/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Infections and infestations
Infection w/ gr3-4 neut, lung
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Infections and infestations
Infection Gr0-2 neut, dental-tooth
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Infections and infestations
Infection Gr0-2 neut, eye NOS
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Infections and infestations
Infection Gr0-2 neut, lung
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Infections and infestations
Infection Gr0-2 neut, middle ear
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Infections and infestations
Infection Gr0-2 neut, oral cavity
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Infections and infestations
Infection Gr0-2 neut, salivary
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Infections and infestations
Infection Gr0-2 neut, sinus
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Infections and infestations
Infection Gr0-2 neut, skin
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Infections and infestations
Infection Gr0-2 neut, ungual
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Infections and infestations
Infection Gr0-2 neut, urinary tract
|
6.0%
3/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Infections and infestations
Infection w/ unk ANC sinus
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Infections and infestations
Infection-other
|
34.0%
17/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Injury, poisoning and procedural complications
Wound - non-infectious
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
Leukocytes
|
20.0%
10/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
Lymphopenia
|
14.0%
7/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
Neutrophils
|
18.0%
9/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
Platelets
|
26.0%
13/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
Weight gain
|
6.0%
3/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
Weight loss
|
42.0%
21/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
Coagulation-other
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
Alkaline phosphatase
|
12.0%
6/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
ALT, SGPT
|
26.0%
13/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
Amylase
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
AST, SGOT
|
36.0%
18/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
Hypercholesterolemia
|
58.0%
29/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
Creatinine
|
14.0%
7/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
Lipase
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Investigations
Metabolic/Laboratory-other
|
6.0%
3/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Metabolism and nutrition disorders
Pancreatic glucose intolerance
|
6.0%
3/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Metabolism and nutrition disorders
Anorexia
|
48.0%
24/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Metabolism and nutrition disorders
Alkalosis
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.0%
4/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
24.0%
12/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
32.0%
16/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.0%
3/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.0%
4/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.0%
4/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
38.0%
19/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic lower extr muscle weak
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic upper extr muscle weak
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
8.0%
4/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
34.0%
17/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Musculoskeletal and connective tissue disorders
Bone, pain
|
10.0%
5/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall, pain
|
8.0%
4/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
20.0%
10/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
22.0%
11/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
6.0%
3/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Musculoskeletal and connective tissue disorders
Neck, pain
|
8.0%
4/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Nervous system disorders
Taste disturbance
|
38.0%
19/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Nervous system disorders
Dizziness
|
18.0%
9/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Nervous system disorders
Neuropathy CN VIII hearing + balance
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Nervous system disorders
Neuropathy-motor
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Nervous system disorders
Neuropathy-sensory
|
8.0%
4/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Nervous system disorders
Tremor
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Nervous system disorders
Neurologic-other
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Nervous system disorders
Head/headache
|
30.0%
15/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Nervous system disorders
Neuropathic, pain
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Psychiatric disorders
Insomnia
|
32.0%
16/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Psychiatric disorders
Confusion
|
6.0%
3/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Psychiatric disorders
Anxiety
|
18.0%
9/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Psychiatric disorders
Depression
|
10.0%
5/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Psychiatric disorders
Libido
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Renal and urinary disorders
Urinary hemorrhage NOS
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Renal and urinary disorders
Proteinuria
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Renal and urinary disorders
Bladder, pain
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Renal and urinary disorders
Urethra, pain
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Renal and urinary disorders
Cystitis
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Renal and urinary disorders
Incontinence urinary
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Renal and urinary disorders
Obstruction-bladder
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Renal and urinary disorders
Obstruction-ureteral
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Renal and urinary disorders
Renal failure
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
10.0%
5/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Renal and urinary disorders
Urine color
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Renal and urinary disorders
Renal/GU-other
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Reproductive system and breast disorders
Pelvic, pain
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Reproductive system and breast disorders
Scrotum, pain
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Reproductive system and breast disorders
Testicle, pain
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Reproductive system and breast disorders
Sexual/Reproductive function-Other
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
16.0%
8/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleura, pain
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat/pharynx/larynx, pain
|
14.0%
7/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
62.0%
31/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
56.0%
28/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Edema, larynx
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Fistula trachea
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reaction
|
10.0%
5/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
10.0%
5/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
14.0%
7/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
16.0%
8/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
24.0%
12/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Skin and subcutaneous tissue disorders
Sweating
|
8.0%
4/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.0%
8/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Skin and subcutaneous tissue disorders
Induration/fibrosis
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
16.0%
8/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
8.0%
4/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
10.0%
5/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
44.0%
22/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
32.0%
16/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Skin and subcutaneous tissue disorders
Skin, pain
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Vascular disorders
Hypertension
|
14.0%
7/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Vascular disorders
Hypotension
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Vascular disorders
Flushing
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Vascular disorders
Hot flashes
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Vascular disorders
Hemorrhage-other
|
4.0%
2/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Vascular disorders
Dermal change lymphedema
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
6.0%
3/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
|
Vascular disorders
Vascular-Other (Specify)
|
2.0%
1/50 • Assessed while on treatment and then up to 30 days after discontinuing treatment; up to 31 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place